Acute Effects of Juice Consumption With Biofunctional Compounds and Probiotics on Glucose Metabolism

Acute Effects of Fruit Juice Enriched With Vitamin D3 or n-3 Fatty Acids or Probiotics and the Combination of the Three Ingredients on Glucose Metabolism in Healthy Adults

This study investigated the short-term effects of fruit juice enriched with Vitamin D3 or n-3 PUFA or probiotics and the combination of the three ingredients on glucose metabolism.

Study Overview

• Status: Completed
• Conditions: Appetite Disorders; Potential Abnormality of Glucose Tolerance
• Intervention / Treatment: Other: Glucose as reference food; Other: Control juice; Other: Juice with vitamin D3; Other: Juice with n-3 fatty acids; Other: Juice with probiotics; Other: Juice with probiotics, vitamin D3, and n-3 fatty acids

Detailed Description

This study aimed to 1. Determine the glycemic index and glycemic load of mixed fruit juice (pomegranate, grape, apple, and orange) enriched with Vitamin D3 or n-3 PUFA or probiotics, and the combination of the three bio-functional ingredients, compared to regular mixed fruit juice and the reference food (D-glucose), and 2.Examine the short-term effects of the five mixed fruit juices on postprandial blood glucose and salivary insulin responses, blood pressure, and subjective appetite, in healthy adults.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Attica
    • Athens, Attica, Greece, 11855
      • Agricultural University of Athens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy
• Non-smoking
• Non-diabetic men and women
• Body mass index between 18.5 and 25 kg.m2

Exclusion Criteria:

• Severe chronic disease (e.g. cardiovascular diseases, diabetes mellitus, kidney or liver conditions, endocrine conditions)
• Gastrointestinal disorders
• Pregnancy
• Lactation
• Competitive sports
• Alcohol abuse
• Drug dependency

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Glucose as reference food; Eleven healthy, normal body weight (male: 6, female: 5) adults after a 12hr fast, consumed 50g available carbohydrates from D-glucose, tested two times, in different visits as reference food, along with 300mL water. Fingertip capillary blood glucose samples were collected at baseline and 15, 30, 45, 60, 90, 120, 150, and 180 min after test drink consumption. Salivary insulin samples were collected at baseline, 15, 30, 45, 60, 90, 120, and 180 min after test drink consumption.	Other: Glucose as reference food; Eleven healthy, normal body weight subjects after 10-14hr fast, consumed 50g glucose diluted in 300mL water, tested two times, in different visits, within 5-10 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90, 120, 150 and 180 min. Salivary insulin samples were taken at baseline, 15, 30, 45, 60, 90, 120, and 180 min.; Other Names: reference drink D-Glucose
Experimental: Control juice; Eleven healthy, normal body weight (male: 6, female: 5) adults after a 12hr fast, consumed 50g available carbohydrates from control mixed fruit juice (pomegranate, grape, apple and orange), tested once, in random order, along with 300mL water. Fingertip capillary blood glucose samples were collected at baseline and 15, 30, 45, 60, 90, 120, 150, and 180 min after test drink consumption. Salivary insulin samples were collected at baseline, 15, 30, 45, 60, 90, 120, and 180 min after test drink consumption.	Other: Control juice; Eleven healthy, normal body weight subjects after 10-14hr fast, consumed 50g available carbohydrates from control juice (consisted of pomegranate, grape, apple and orange), tested once, within 5-10 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90, 120, 150 and 180 min. Salivary insulin samples were taken at baseline, 15, 30, 45, 60, 90, 120, and 180 min.
Experimental: Juice containing vitamin D3; Eleven healthy, normal body weight (male: 6, female: 5) adults after a 12hr fast, consumed 50g available carbohydrates from mixed fruit juice enriched with vitamin D3, tested once, in random order, along with 300mL water. Fingertip capillary blood glucose samples were collected at baseline and 15, 30, 45, 60, 90, 120, 150, and 180 min after test drink consumption. Salivary insulin samples were collected at baseline, 15, 30, 45, 60, 90, 120, and 180 min after test drink consumption.	Other: Juice with vitamin D3; Eleven healthy, normal body weight subjects after 10-14hr fast, consumed 50g available carbohydrates from juice (consisted of pomegranate, grape, apple and orange) containing vitamin D3, tested once, within 5-10 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90, 120, 150 and 180 min. Salivary insulin samples were taken at baseline, 15, 30, 45, 60, 90, 120, and 180 min.; Other Names: Vitamin D3
Experimental: Juice containing n-3 polyunsaturated fatty acids (PUFA); Eleven healthy, normal body weight (male: 6, female: 5) adults after a 12hr fast, consumed 50g available carbohydrates from mixed fruit juice enriched with n-3 PUFA, tested once, in random order, along with 300mL water. Fingertip capillary blood glucose samples were collected at baseline and 15, 30, 45, 60, 90, 120, 150, and 180 min after test drink consumption. Salivary insulin samples were collected at baseline, 15, 30, 45, 60, 90, 120, and 180 min after test drink consumption.	Other: Juice with n-3 fatty acids; Eleven healthy, normal body weight subjects after 10-14hr fast, consumed 50g available carbohydrates from juice (consisted of pomegranate, grape, apple and orange) containing n-3 fatty acids, tested once, within 5-10 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90, 120, 150 and 180 min. Salivary insulin samples were taken at baseline, 15, 30, 45, 60, 90, 120, and 180 min.; Other Names: n-3 fatty acids
Experimental: Juice containing probiotics; Eleven healthy, normal body weight (male: 6, female: 5) adults after a 12hr fast, consumed 50g available carbohydrates from mixed fruit juice enriched with probiotics, tested once, in random order, along with 300mL water. Fingertip capillary blood glucose samples were collected at baseline and 15, 30, 45, 60, 90, 120, 150, and 180 min after test drink consumption. Salivary insulin samples were collected at baseline, 15, 30, 45, 60, 90, 120, and 180 min after test drink consumption.	Other: Juice with probiotics; Eleven healthy, normal body weight subjects after 10-14hr fast, consumed 50g available carbohydrates from juice (consisted of pomegranate, grape, apple and orange) containing probiotics, tested once, within 5-10 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90, 120, 150 and 180 min. Salivary insulin samples were taken at baseline, 15, 30, 45, 60, 90, 120, and 180 min.; Other Names: probiotics
Experimental: Juice containing probiotics, vitamin D3, and n-3 PUFA; Eleven healthy, normal body weight (male: 6, female: 5) adults after a 12hr fast, consumed 50g available carbohydrates from a mixed juice enriched with probiotics, vitamin D3, and n-3 PUFA, tested once, in random order, along with 300mL water. Fingertip capillary blood glucose samples were collected at baseline and 15, 30, 45, 60, 90, 120, 150, and 180 min after test drink consumption. Salivary insulin samples were collected at baseline, 15, 30, 45, 60, 90, 120, and 180 min after test drink consumption.	Other: Juice with probiotics, vitamin D3, and n-3 fatty acids; Eleven healthy, normal body weight subjects after 10-14hr fast, consumed 50g available carbohydrates from juice (consisted of pomegranate, grape, apple and orange) containing probiotics, vitamin D3 and n-3 fatty acids, tested once, within 5-10 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90, 120, 150 and 180 min. Salivary insulin samples were taken at baseline, 15, 30, 45, 60, 90, 120, and 180 min.; Other Names: probiotics, vitamin D-3, and n-3 fatty acids

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Capillary blood glucose responses	Clinically useful change in blood glucose, defined as the restoration of glucose within normal limits during the 3hr glucose tolerance test	3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Salivary insulin responses	Clinically useful change in salivary insulin, defined as the restoration of insulin within normal limits during the 3hr glucose torelance test	3 hours
Blood pressure	Useful change in systolic and diastolic blood pressure before and 3hr after consumption of the juices.	3 hours
Subjective appetite rating	Useful change in subjective appetite using visual analogue scales (VAS). Participants rated their hunger, desire to eat, perceived fullness, thirst, preoccupation with food, pleasure of eating the consumed test food, and thirst, after eating on a horizontal line VAS, with a line length of 10 cm, a line width of 3 desktop publishing points, was black, had flat line endpoints, had an ascending numerical order of scale endpoints [i.e., "0" and "10", for example neither hungry (0 mm), full (100 mm) or have desire for food in the middle (50 mm)], and used "0" and "10" as numerical anchors below the left and right endpoints, respectively.	3 hours

Collaborators and Investigators

• Sponsor: Agricultural University of Athens
• Investigators: Principal Investigator: Emilia Papakonstantinou, PhD, Agricultural University of Athens

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2022
• Primary Completion (Actual): December 20, 2022
• Study Completion (Actual): January 25, 2023

Study Registration Dates

• First Submitted: January 19, 2023
• First Submitted That Met QC Criteria: January 19, 2023
• First Posted (Actual): January 27, 2023

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: glycemic index; probiotics; n-3 fatty acids; insulin; blood glucose; vitamin D3; glycemic load; juices
• Additional Relevant MeSH Terms: Mental Disorders; Feeding and Eating Disorders; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Vitamins; Ergocalciferols
• Other Study ID Numbers: HRBD 78 12.10.2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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