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

Not Applicable

Completed

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

• Registration Number: NCT05702359
• Lead Sponsor: Agricultural University of Athens

Brief Summary

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.

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 Timeline

• Study Start: 2022-11-02
• Primary Completion: 2022-12-20
• Study First Submitted: 2023-01-19
• Study First Submitted QC: 2023-01-19
• Study Completion: 2023-01-25
• Study First Posted: 2023-01-27
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Glucose as reference food	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.
Control juice	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.
Juice containing n-3 polyunsaturated fatty acids (PUFA)	Juice with n-3 fatty acids	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.
Juice containing vitamin D3	Juice with 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.
Juice containing probiotics	Juice with 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.
Juice containing probiotics, vitamin D3, and n-3 PUFA	Juice with probiotics, vitamin D3, and n-3 fatty acids	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Blood pressure	3 hours	Useful change in systolic and diastolic blood pressure before and 3hr after consumption of the juices.
Subjective appetite rating	3 hours	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.
Salivary insulin responses	3 hours	Clinically useful change in salivary insulin, defined as the restoration of insulin within normal limits during the 3hr glucose torelance test

Trial Locations

Locations (1)

Agricultural University of Athens; 🇬🇷 Athens, Attica, Greece