Food Matrices Based on Fruit Pastes as Vectors of Carbohydrates for the Prevention and Management of Protein-energy Undernutrition in the Elderly (Fruisenior) (Fruisenior)

Food Matrices Based on Fruit Pastes as Vectors of Carbohydrates for the Prevention and Management of Protein-energy Undernutrition in the Elderly: Proof of Clinical Concept

To develop more natural fruit pastes matrices that can effectively act as carbohydrate vectors in the elderly population and that are part of a normal diet while maintaining the pleasure of eating.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: fruit paste matrice

Detailed Description

This is an interventional randomized, single blinded, cross over and controlled study.

The main objective is the study of the kinetic modification of blood glucose with the "fruit" matrices enriched in maltodextrins, fructose and isomaltulose compared to the original recipe consisting only of simple sugars.

The secondary objective is:

-the assessment of the acceptability of all the fruit pastes tested (organoleptic, satiety and gastrointestinal comfort aspects).The study is composed of 7 visits Visit 1 - Selection Visit (Day -7)

• Informed consent form
• Clinical examination
• Medical history
• Anthropometric characteristics
• Blood biochemical and hematological assessment
• Compliance test with the original matrix will be carried out

Visit 2 (D0) / Visit 3 (D7) / Visit 4 (D14) / Visit 5 (D21) / Visit 6 (D28): study period If all the biological criteria are respected, the subjects will have to come back to the clinical center for each of the 5 study periods.

Volunteers will arrive fasted, without smoking in the morning. A catheter will be placed for blood sampling. After a first blood sampling for basal values, volunteers will ingest the equivalent of two bars of fruit pastes (about 80g in 10 minutes maximum) and blood will be withdrawn 15, 30, 45, 60, 90, 120 and 180 minutes after ingestion. The different matrices (5 in total) will be tested on the same volunteer. Plasma samples will be used to determine plasma glucose and fructose concentrations (aliquots stored in center for later assays) to evaluate the postprandial profiles of these two nutrients. At the end of the kinetic, the volunteers will be offered a complete meal. A satiety questionnaire will be performed before then 60 and 180 min after the ingestion of each fruit matrix. A questionnaire of satisfaction and acceptability will also be realized during the consumption of the matrix.

After the 5 fruit matrix will be tested, the subject will be invited to participate in an individual interview of about 30-45min with a member of the project team. The purpose of this interview will be a qualitative approach to search for a food development that can could improve the sensory quality of the fruit pastes tested and intended for the elderly (see below).

Visit 7 (D35 to D40): Participation in a discussion group (about 2 hours). During the participation in this group all 10 participants will be invited to taste the 5 products (original recipe, maltodextrin recipe, fructose recipe, isomaltulose recipe and mixed recipe comprising fructose and isomaltulose). Participants will be asked to indicate for each product their degree of appreciation for these products, their possible defects and qualities and to suggest ideas for improving their taste / texture / appearance. These interviews will alternate individual reflection phases and discussion phases according to the focus group method.

Visit 7 will be the last visit of the study.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63000
    • CHU de Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Male subject
• Subject over 65 years (included)
• Subject over 61 kg (included)
• Able to consume the 80g of fruit pastes in 10 minutes
• Subject with a dentition consistent with the fruit paste consumption in 10 minutes
• Subject with a Body Mass Index (BMI) between 21 and 30 kg/m2
• Subject agreeing to provide written consent

Exclusion Criteria:

• Subject with acute pathology (unstable or terminal pathology, severe dementia)
• Subject with renal failure (clearance < 60 ml/min)
• Subject with metabolic syndrome (3 of the following 5 criteria: waist greater than 94 cm, blood triglyceride greater than 1.7 mmol/l, blood pressure greater than or equal to 130 mm Hg/85 mm Hg, cholesterol (HDL) less than 1.0 mmol/l in men, blood glucose greater than or equal to 5.6 mmol/l)
• Person with diabetes
• Subject on food restriction
• Subject undergoing chemotherapy
• Subject with gastrointestinal pathology
• Subject in a diet incompatible with the nutritional protocol (gluten, lactose or milk intolerance, vegan)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Original recipe; Normal fruit paste	Other: fruit paste matrice; Evaluation of the kinetics of the appearance of nutrients and the metabolic response induced by the consumption of fruit pastes (5 different matrices will be tested: 1 Original recipe, 1 maltodextrine recipe, 1 fructose recipe, 1 isomaltulose recipe and 1 mixed recipe comprising fructose and isomaltulose) in elderly healthy volunteers.
Experimental: maltodextrin recipe; fruit pastes in which some of the simple sugars in the recipe will be replaced by maltodextrin with a low glycemic index (DE12).	Other: fruit paste matrice; Evaluation of the kinetics of the appearance of nutrients and the metabolic response induced by the consumption of fruit pastes (5 different matrices will be tested: 1 Original recipe, 1 maltodextrine recipe, 1 fructose recipe, 1 isomaltulose recipe and 1 mixed recipe comprising fructose and isomaltulose) in elderly healthy volunteers.
Experimental: fructose recipe; fruit pastes in which some of the simple sugars in the recipe (25% min) will be replaced by fructose	Other: fruit paste matrice; Evaluation of the kinetics of the appearance of nutrients and the metabolic response induced by the consumption of fruit pastes (5 different matrices will be tested: 1 Original recipe, 1 maltodextrine recipe, 1 fructose recipe, 1 isomaltulose recipe and 1 mixed recipe comprising fructose and isomaltulose) in elderly healthy volunteers.
Experimental: isomaltulose recipe; fruit pastes with some of the sugars will be replaced (25% min) by isomaltulose	Other: fruit paste matrice; Evaluation of the kinetics of the appearance of nutrients and the metabolic response induced by the consumption of fruit pastes (5 different matrices will be tested: 1 Original recipe, 1 maltodextrine recipe, 1 fructose recipe, 1 isomaltulose recipe and 1 mixed recipe comprising fructose and isomaltulose) in elderly healthy volunteers.
Experimental: mixed recipe; fruit pastes with some of the sugars will be replaced (25% min) by fructose / isomaltulose	Other: fruit paste matrice; Evaluation of the kinetics of the appearance of nutrients and the metabolic response induced by the consumption of fruit pastes (5 different matrices will be tested: 1 Original recipe, 1 maltodextrine recipe, 1 fructose recipe, 1 isomaltulose recipe and 1 mixed recipe comprising fructose and isomaltulose) in elderly healthy volunteers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Curve (AUC) of glycemia	Area Under the Curve (AUC) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.	Day 0
Maximum Plasma Concentration (Cmax) of glycemia	Maximum Plasma Concentration (Cmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.	Day 0
Time of Maximum Plasma Concentration (Tmax) of glycemia	Time of Maximum Plasma Concentration (Tmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.	Day 0
Area Under the Curve (AUC) of glycemia	Area Under the Curve (AUC) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.	Day 7
Maximum Plasma Concentration (Cmax) of glycemia	Maximum Plasma Concentration (Cmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.	Day 7
Time of Maximum Plasma Concentration (Tmax) of glycemia	Time of Maximum Plasma Concentration (Tmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.	day 7
Area Under the Curve (AUC) of glycemia	Area Under the Curve (AUC) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.	day 14
Maximum Plasma Concentration (Cmax) of glycemia	Maximum Plasma Concentration (Cmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.	day 14
Time of Maximum Plasma Concentration (Tmax) of glycemia	Time of Maximum Plasma Concentration (Tmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.	day 14
Area Under the Curve (AUC) of glycemia	Area Under the Curve (AUC) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.	day 21
Maximum Plasma Concentration (Cmax) of glycemia	Maximum Plasma Concentration (Cmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.	day 21
Time of Maximum Plasma Concentration (Tmax) of glycemia	Time of Maximum Plasma Concentration (Tmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.	day 21
Area Under the Curve (AUC) of glycemia	Area Under the Curve (AUC) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.	day 28
Maximum Plasma Concentration (Cmax) of glycemia	Maximum Plasma Concentration (Cmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste	day 28
Time of Maximum Plasma Concentration (Tmax) of glycemia	Time of Maximum Plasma Concentration (Tmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.	day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Curve (AUC) of fructose	Area Under the Curve (AUC) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.	Day 0
Maximum Plasma Concentration (Cmax) of fructose	Maximum Plasma Concentration (Cmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.	Day 0
Time of Maximum Plasma Concentration (Tmax) of fructose	Time of Maximum Plasma Concentration (Tmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.	Day 0
Area Under the Curve (AUC) of fructose	Area Under the Curve (AUC) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste	Day 7
Maximum Plasma Concentration (Cmax) of fructose	Maximum Plasma Concentration (Cmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.	Day 7
Time of Maximum Plasma Concentration (Tmax) of fructose	Time of Maximum Plasma Concentration (Tmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.	Day 7
Area Under the Curve (AUC) of fructose	Area Under the Curve (AUC) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.	Day 14
Maximum Plasma Concentration (Cmax) of fructose	Maximum Plasma Concentration (Cmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.	Day 14
Time of Maximum Plasma Concentration (Tmax) of fructose	Time of Maximum Plasma Concentration (Tmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.	Day 14
Area Under the Curve (AUC) of fructose	Area Under the Curve (AUC) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste	Day 21
Maximum Plasma Concentration (Cmax) of fructose	Maximum Plasma Concentration (Cmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.	Day 21
Time of Maximum Plasma Concentration (Tmax) of fructose	Time of Maximum Plasma Concentration (Tmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.	Day 21
Area Under the Curve (AUC) of fructose	Area Under the Curve (AUC) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste	Day 28
Maximum Plasma Concentration (Cmax) of fructose	Maximum Plasma Concentration (Cmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.	Day 28
Time of Maximum Plasma Concentration (Tmax) of fructose	Time of Maximum Plasma Concentration (Tmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.	Day 28
Area Under the Curve (AUC) of glucagon	Area Under the Curve (AUC) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.	day 0
Maximum Plasma Concentration (Cmax) of glucagon	: Maximum Plasma Concentration (Cmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.	day 0
Time of Maximum Plasma Concentration (Tmax) of glucagon	Time of Maximum Plasma Concentration (Tmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.	day 0
Area Under the Curve (AUC) of glucagon	Area Under the Curve (AUC) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste	day 7
Maximum Plasma Concentration (Cmax) of glucagon	Maximum Plasma Concentration (Cmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste	day 7
Time of Maximum Plasma Concentration (Tmax) of glucagon	Time of Maximum Plasma Concentration (Tmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste	Day 7
Area Under the Curve (AUC) of glucagon	Area Under the Curve (AUC) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste	Day 14
Maximum Plasma Concentration (Cmax) of glucagon	Maximum Plasma Concentration (Cmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.	Day 14
Time of Maximum Plasma Concentration (Tmax) of glucagon	Time of Maximum Plasma Concentration (Tmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste	Day 14
Area Under the Curve (AUC) of glucagon	Area Under the Curve (AUC) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.	Day 21
Maximum Plasma Concentration (Cmax) of glucagon	Maximum Plasma Concentration (Cmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.	Day 21
Time of Maximum Plasma Concentration (Tmax) of glucagon	Time of Maximum Plasma Concentration (Tmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.	Day 21
Area Under the Curve (AUC) of glucagon	Area Under the Curve (AUC) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste	Day 28
Maximum Plasma Concentration (Cmax) of glucagon	Maximum Plasma Concentration (Cmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.	Day 28
Time of Maximum Plasma Concentration (Tmax) of glucagon	Time of Maximum Plasma Concentration (Tmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.	Day 28
Area Under the Curve (AUC) of CCK	Area Under the Curve (AUC) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.	Day 0
Maximum Plasma Concentration (Cmax) of CCK	Maximum Plasma Concentration (Cmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste	Day 0
Time of Maximum Plasma Concentration (Tmax) of CCK	Time of Maximum Plasma Concentration (Tmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.	Day 0
Area Under the Curve (AUC) of CCK	Area Under the Curve (AUC) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.	Day 7
Maximum Plasma Concentration (Cmax) of CCK	Maximum Plasma Concentration (Cmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste	Day 7
Time of Maximum Plasma Concentration (Tmax) of CCK	Time of Maximum Plasma Concentration (Tmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.	Day 7
Area Under the Curve (AUC) of CCK	Area Under the Curve (AUC) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.	Day 14
Maximum Plasma Concentration (Cmax) of CCK	Maximum Plasma Concentration (Cmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.	Day 14
Time of Maximum Plasma Concentration (Tmax) of CCK	Time of Maximum Plasma Concentration (Tmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.	Day 14
Area Under the Curve (AUC) of CCK	Area Under the Curve (AUC) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste	Day 21
Maximum Plasma Concentration (Cmax) of CCK	Maximum Plasma Concentration (Cmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste	Day 21
Time of Maximum Plasma Concentration (Tmax) of CCK	Time of Maximum Plasma Concentration (Tmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.	Day 21
Area Under the Curve (AUC) of CCK	Area Under the Curve (AUC) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.	Day 28
Maximum Plasma Concentration (Cmax) of CCK	Maximum Plasma Concentration (Cmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.	Day 28
Time of Maximum Plasma Concentration (Tmax) of CCK	Time of Maximum Plasma Concentration (Tmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.	Day 28
Area Under the Curve (AUC) of Grehlin	Area Under the Curve (AUC) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.	Day 0
Maximum Plasma Concentration (Cmax) of Grehlin	Maximum Plasma Concentration (Cmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.	Day 0
Time of Maximum Plasma Concentration (Tmax) of Grehlin	Time of Maximum Plasma Concentration (Tmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.	day 0
Area Under the Curve (AUC) of Grehlin	Area Under the Curve (AUC) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste	day 7
Maximum Plasma Concentration (Cmax) of Grehlin	Maximum Plasma Concentration (Cmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.	day 7
Time of Maximum Plasma Concentration (Tmax) of Grehlin	Time of Maximum Plasma Concentration (Tmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste	day 7
Area Under the Curve (AUC) of Grehlin	Area Under the Curve (AUC) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste	day 14
Maximum Plasma Concentration (Cmax) of Grehlin	Maximum Plasma Concentration (Cmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.	day 14
Time of Maximum Plasma Concentration (Tmax) of Grehlin	Time of Maximum Plasma Concentration (Tmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.	day 14
Area Under the Curve (AUC) of Grehlin	Area Under the Curve (AUC) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste	day 21
Maximum Plasma Concentration (Cmax) of Grehlin	Maximum Plasma Concentration (Cmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.	day 21
Time of Maximum Plasma Concentration (Tmax) of Grehlin	Time of Maximum Plasma Concentration (Tmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.	day 21
Area Under the Curve (AUC) of Grehlin	Area Under the Curve (AUC) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste	day 28
Maximum Plasma Concentration (Cmax) of Grehlin	Maximum Plasma Concentration (Cmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.	day 28
Time of Maximum Plasma Concentration (Tmax) of Grehlin	Time of Maximum Plasma Concentration (Tmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.	day 28
Area Under the Curve (AUC) of leptin	Area Under the Curve (AUC) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste	day 0
Maximum Plasma Concentration (Cmax) of leptin	Maximum Plasma Concentration (Cmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste.	day 0
Time of Maximum Plasma Concentration (Tmax) of leptin	Time of Maximum Plasma Concentration (Tmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste.	day 0
Area Under the Curve (AUC) of leptin	Area Under the Curve (AUC) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste	day 7
Maximum Plasma Concentration (Cmax) of leptin	Maximum Plasma Concentration (Cmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste.	day 7
Time of Maximum Plasma Concentration (Tmax) of leptin	Time of Maximum Plasma Concentration (Tmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste	day 7
Area Under the Curve (AUC) of leptin	Area Under the Curve (AUC) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste	day 14
Maximum Plasma Concentration (Cmax) of leptin	Maximum Plasma Concentration (Cmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste	day 14
Time of Maximum Plasma Concentration (Tmax) of leptin	Time of Maximum Plasma Concentration (Tmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste	day 14
Area Under the Curve (AUC) of leptin	Area Under the Curve (AUC) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste	day 21
Maximum Plasma Concentration (Cmax) of leptin	Maximum Plasma Concentration (Cmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste.	day 21
Time of Maximum Plasma Concentration (Tmax) of leptin	Time of Maximum Plasma Concentration (Tmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste.	day 21
Area Under the Curve (AUC) of leptin	Area Under the Curve (AUC) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste	day 28
Maximum Plasma Concentration (Cmax) of leptin	Maximum Plasma Concentration (Cmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste.	day 28
Time of Maximum Plasma Concentration (Tmax) of leptin	Time of Maximum Plasma Concentration (Tmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste.	day 28
Area Under the Curve (AUC) of GLP1	Area Under the Curve (AUC) of GLP1 (defined in pmol/L) between T0 and T120 minutes following ingestion of fruit paste	day 0
Maximum Plasma Concentration (Cmax) of GLP1	Maximum Plasma Concentration (Cmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste	day 0
Time of Maximum Plasma Concentration (Tmax) of GLP1	Time of Maximum Plasma Concentration (Tmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste.	day 0
Area Under the Curve (AUC) of GLP1	Area Under the Curve (AUC) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste.	day 7
Maximum Plasma Concentration (Cmax) of GLP1	Maximum Plasma Concentration (Cmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste.	day 7
Time of Maximum Plasma Concentration (Tmax) of GLP1	Time of Maximum Plasma Concentration (Tmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste	day 7
Area Under the Curve (AUC) of GLP1	Area Under the Curve (AUC) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste	day 14
Maximum Plasma Concentration (Cmax) of GLP1	Maximum Plasma Concentration (Cmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste.	day 14
Time of Maximum Plasma Concentration (Tmax) of GLP1	Time of Maximum Plasma Concentration (Tmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste.	day 14
Area Under the Curve (AUC) of GLP1	Area Under the Curve (AUC) of GLP1 (defined in pmol/L) between T0 and T120 minutes following ingestion of fruit paste	day 21
Maximum Plasma Concentration (Cmax) of GLP1	Maximum Plasma Concentration (Cmax) of GLP1 (defined in pmol/L) between T0 and T120 minutes following ingestion of fruit paste.	day 21
Time of Maximum Plasma Concentration (Tmax) of GLP1	Time of Maximum Plasma Concentration (Tmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste.	day 21
Area Under the Curve (AUC) of GLP1	Area Under the Curve (AUC) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste	day 28
Maximum Plasma Concentration (Cmax) of GLP1	Maximum Plasma Concentration (Cmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste	day 28
Time of Maximum Plasma Concentration (Tmax) of GLP1	Time of Maximum Plasma Concentration (Tmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste.	day 28
Area Under the Curve (AUC) of incretines	Area Under the Curve (AUC) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste	day 0
Maximum Plasma Concentration (Cmax) of incretines	Maximum Plasma Concentration (Cmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.	day 0
Time of Maximum Plasma Concentration (Tmax) of incretines	Time of Maximum Plasma Concentration (Tmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.	day 0
Area Under the Curve (AUC) of incretines	Area Under the Curve (AUC) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste	day 7
Maximum Plasma Concentration (Cmax) of incretines	Maximum Plasma Concentration (Cmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste	day 7
Time of Maximum Plasma Concentration (Tmax) of incretines	Time of Maximum Plasma Concentration (Tmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.	day 7
Area Under the Curve (AUC) of incretines	Area Under the Curve (AUC) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste	day 14
Maximum Plasma Concentration (Cmax) of incretines	Maximum Plasma Concentration (Cmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.	day 14
Time of Maximum Plasma Concentration (Tmax) of incretines	Time of Maximum Plasma Concentration (Tmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste	day 14
Area Under the Curve (AUC) of incretines	Area Under the Curve (AUC) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste	day 21
Maximum Plasma Concentration (Cmax) of incretines	Maximum Plasma Concentration (Cmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.	day 21
Time of Maximum Plasma Concentration (Tmax) of incretines	Time of Maximum Plasma Concentration (Tmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste	day 21
Area Under the Curve (AUC) of incretines	Area Under the Curve (AUC) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste	day 28
Maximum Plasma Concentration (Cmax) of incretines	Maximum Plasma Concentration (Cmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.	day 28
Time of Maximum Plasma Concentration (Tmax) of incretines	Time of Maximum Plasma Concentration (Tmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste	day 28
Area Under the Curve (AUC) of insulin	Area Under the Curve (AUC) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste	day 0
Maximum Plasma Concentration (Cmax) of insulin	Maximum Plasma Concentration (Cmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste	day 0
Time of Maximum Plasma Concentration (Tmax) of insulin	Time of Maximum Plasma Concentration (Tmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste.	day 0
Area Under the Curve (AUC) of insulin	Area Under the Curve (AUC) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste	day 7
Maximum Plasma Concentration (Cmax) of insulin	Maximum Plasma Concentration (Cmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste	day 7
Time of Maximum Plasma Concentration (Tmax) of insulin	Time of Maximum Plasma Concentration (Tmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste.	day 7
Area Under the Curve (AUC) of insulin	Area Under the Curve (AUC) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste	day 14
Maximum Plasma Concentration (Cmax) of insulin	Maximum Plasma Concentration (Cmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste	day 14
Time of Maximum Plasma Concentration (Tmax) of insulin	Time of Maximum Plasma Concentration (Tmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste	day 14
Area Under the Curve (AUC) of insulin	Area Under the Curve (AUC) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste	day 21
Maximum Plasma Concentration (Cmax) of insulin	Maximum Plasma Concentration (Cmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste	day 21
Time of Maximum Plasma Concentration (Tmax) of insulin	Time of Maximum Plasma Concentration (Tmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste.	day 21
Area Under the Curve (AUC) of insulin	Area Under the Curve (AUC) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste	day 28
Maximum Plasma Concentration (Cmax) of urea	Maximum Plasma Concentration (Cmax) of urea (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste	day 28
Time of Maximum Plasma Concentration (Tmax) of insulin	Time of Maximum Plasma Concentration (Tmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste.	day 28
Area Under the Curve (AUC) of urea	Area Under the Curve (AUC) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste	day 0
Maximum Plasma Concentration (Cmax) of urea	Maximum Plasma Concentration (Cmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste	day 0
Time of Maximum Plasma Concentration (Tmax) of urea	Time of Maximum Plasma Concentration (Tmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.	day 0
Area Under the Curve (AUC) of urea	Area Under the Curve (AUC) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste	day 7
Maximum Plasma Concentration (Cmax) of urea	Maximum Plasma Concentration (Cmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste	day 7
Time of Maximum Plasma Concentration (Tmax) of urea	Time of Maximum Plasma Concentration (Tmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.	day 7
Area Under the Curve (AUC) of urea	Area Under the Curve (AUC) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.	day 14
Maximum Plasma Concentration (Cmax) of urea	Maximum Plasma Concentration (Cmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste	day 14
Time of Maximum Plasma Concentration (Tmax) of urea	Time of Maximum Plasma Concentration (Tmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.	day 14
Area Under the Curve (AUC) of urea	Area Under the Curve (AUC) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste	day 21
Maximum Plasma Concentration (Cmax) of urea	Maximum Plasma Concentration (Cmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste	day 21
Time of Maximum Plasma Concentration (Tmax) of urea	Time of Maximum Plasma Concentration (Tmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.	day 21
Area Under the Curve (AUC) of urea	Area Under the Curve (AUC) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste	day 28
Maximum Plasma Concentration (Cmax) of urea	Maximum Plasma Concentration (Cmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.	day 28
Time of Maximum Plasma Concentration (Tmax) of urea	Time of Maximum Plasma Concentration (Tmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste	day 28
Questionnaire of satiety	Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry.	at time 0 after ingestion in Day 0
Questionnaire of satiety	Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry	at time 60 after ingestion in Day 0
Questionnaire of satiety	Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry.	at time 180 after ingestion in Day 0
Questionnaire of satiety	Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry	at time 0 after ingestion in Day 7
Questionnaire of satiety	Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry	at time 60 after ingestion in Day 7
Questionnaire of satiety	Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry.	at time 180 after ingestion in Day 7
Questionnaire of satiety	Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry.	at time 0 after ingestion in Day 14
Questionnaire of satiety	Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry	at time 60 after ingestion in Day 14
Questionnaire of satiety	Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry	at time 180 after ingestion in Day 14
Questionnaire of satiety	Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry.	at time 0 after ingestion in Day 21
Questionnaire of satiety	Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry.	at time 60 after ingestion in Day 21
Questionnaire of satiety	Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry.	at time 180 after ingestion in Day 21
Questionnaire of satiety	Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry.	at time 0 after ingestion in Day 28
Questionnaire of satiety	Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry.	at time 60 after ingestion in Day 28
Questionnaire of satiety	Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry.	at time 180 after ingestion in Day 28
Questionnaire of acceptability	Acceptability was assessed by a 7-point time scale where "1" means a very poor acceptability and "7" means a very good acceptability	day 0
Questionnaire of acceptability	Acceptability was assessed by a 7-point time scale where "1" means a very poor acceptability and "7" means a very good acceptability	day 7
Questionnaire of acceptability	Acceptability was assessed by a 7-point time scale where "1" means a very poor acceptability and "7" means a very good acceptability	day 14
Questionnaire of acceptability	Acceptability was assessed by a 7-point time scale where "1" means a very poor acceptability and "7" means a very good acceptability	day 21
Questionnaire of acceptability	Acceptability was assessed by a 7-point time scale where "1" means a very poor acceptability and "7" means a very good acceptability	day 28
Facilited individual interview	Facilitated interview to assess organoleptic, satiety and gastrointestinal comfort	day 40
Focus group	Focus group interview to assess organoleptic, satiety and gastrointestinal comfort	day 40

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: Unité de Nutrition Humaine, INRAE, Centre Auvergne-Rhône Alpes; Unité de recherche CSGA, INRAE Dijon

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2021
• Primary Completion (Actual): July 15, 2021
• Study Completion (Actual): July 19, 2021

Study Registration Dates

• First Submitted: June 16, 2020
• First Submitted That Met QC Criteria: July 20, 2020
• First Posted (Actual): July 22, 2020

Study Record Updates

• Last Update Posted (Actual): September 27, 2022
• Last Update Submitted That Met QC Criteria: September 26, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Dietary intake; Fruit pastes matrices; Elderly healthy volunteer
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: RBHP 2019 PICKERING; 2019-A00995-52 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No