Effect of a Plant-based Ingredient on Generalized Hormonal Responses

The study is designed to determine the extent to which foods containing a plant-based ingredient affect blood glucose and hormonal response in healthy subjects.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: plant-based ingredient; Dietary supplement: No plant-based ingredient

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Gieres, France
    • Eurofins Optimed Clinical research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy males, Age at start of the study >20 and <50 years;
• Body mass index (BMI) ≥ 20,0 and ≤ 25,0 kg/m2;
• Apparently healthy: no medical conditions which might affect the study measurements, absorption, metabolism and distribution (including diabetes type 1 and type 2, gastrointestinal dysfunction, gastrointestinal surgery and inflammatory diseases);
• Fasting blood glucose value of subjects is ≥ 3.4 and ≤ 6.1 mmol/litre (i.e. 62-110 mg/dl) at screening;
• Agreeing to be informed about medically relevant personal test-results by a physician;
• Informed consent signed;
• Willing to comply to study protocol during study;
• Covered by Health Insurance System and/or in compliance with the recommendations of National Law in force relating to biomedical research.
• Accessible veins on arms as determined by examination at screening.

Exclusion Criteria:

• Any history of diabetes, hyper- (or hypo-) glycemia or other disorder of glucose metabolism;
• Blood donation in the past 2 months;
• Reported participation in another nutritional or biomedical trial 3 months before the pre-study examination or during the study;
• Reported participation in night shift work two weeks prior to pre-study investigation or during the study. Night work is defined as working between midnight and 6.00 AM;
• Reported intense sporting activities > 10h/w;
• Consumption of > 21 alcoholic drinks in a typical week;
• Not being used to eat breakfast;
• Reported use of any nicotine containing products in the six months preceding the study and during the study itself;
• Use of medication which interferes with study measurements;
• Reported dietary habits: medically prescribed diet, slimming diet;
• Not used to eat 3 meals a day;
• Vegetarian;
• Reported weight loss/gain (>10%) in the last six month before the study;
• Being an employee of Unilever and CRO;
• Allergy or intolerance to food products and aversion to food products provided during the study;
• Subject who cannot be contacted in case of emergency;
• Subject who, in the judgment of the investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development;
• Subject under guardianship;
• Subject who would receive more than 4500 euro's as indemnities for his participation in biomedical research within the 12 last months, including the indemnities for the present study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Plant-based ingredient to a starchy meal; Plant-based ingredient	Dietary supplement: plant-based ingredient; Dietary supplement: No plant-based ingredient
Other: Starchy meal alone; No plant-based ingredient	Dietary supplement: plant-based ingredient; Dietary supplement: No plant-based ingredient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC of post-prandial hormones	Amylin (total) will be assessed.	120 minutes
AUC of post-prandial hormones	Ghrelin (active) will be assessed.	120 minutes
AUC of post-prandial hormones	Glucose-dependent insulinotropic peptide (gastric inhibitory polypeptide, GIP) (total) will be assessed.	120 minutes
AUC of post-prandial hormones	Glucagon-like peptide-1 (GLP-1) (active) will be assessed.	120 minutes
AUC of post-prandial hormones	Leptin will be assessed.	120 minutes
AUC of post-prandial hormones	Pancreatic polypeptide (PP) will be assessed.	120 minutes
AUC of post-prandial hormones	Peptide YY (PYY) (total) will be assessed.	120 minutes
AUC of post-prandial hormones	Insulin will be assessed.	120 minutes
AUC of post-prandial hormones	C-peptide will be assessed.	120 minutes
AUC of post-prandial hormones	Glucagon will be assessed.	120 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC of post-prandial hormones	Amylin (total) will be assessed.	180 and 240 minutes
AUC of post-prandial hormones	Ghrelin (active) will be assessed.	180 and 240 minutes
AUC of post-prandial hormones	Glucose-dependent insulinotropic peptide (gastric inhibitory polypeptide, GIP) (total) will be assessed.	180 and 240 minutes
AUC of post-prandial hormones	Pancreatic polypeptide (PP) will be assessed.	180 and 240 minutes
AUC of post-prandial hormones	Peptide YY (PYY) (total) will be assessed.	180 and 240 minutes
AUC of post-prandial hormones	Leptin will be assessed.	180 and 240 minutes
AUC of post-prandial hormones	Glucagon will be assessed.	180 and 240 minutes
AUC of post-prandial hormones	Insulin will be assessed.	180 and 240 minutes
AUC of post-prandial hormones	C-peptide will be assessed.	180 and 240 minutes
AUC of post-prandial hormones	Glucagon-like peptide-1 (GLP-1) (active) will be assessed.	180 and 240 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood glucose response (+iAUC)	Effect on blood glucose response.	120 and 180 minutes

Collaborators and Investigators

• Sponsor: Unilever R&D
• Investigators: Principal Investigator: Yves DONAZZOLO, M.D., M.Sc., EUROFINS OPTIMED, GIERES - France

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: November 22, 2013
• First Submitted That Met QC Criteria: December 5, 2013
• First Posted (Estimate): December 6, 2013

Study Record Updates

• Last Update Posted (Estimate): April 9, 2014
• Last Update Submitted That Met QC Criteria: April 8, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: subjects
• Other Study ID Numbers: FDS-NAA-1462