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

NCT05702359 | Completed DMC

• 1 other identifier: HRBD 78 12.10.2022
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Potential Abnormality of Glucose Tolerance; Appetite Disorders

Keywords

blood glucose; insulin; glycemic index; glycemic load; juices; probiotics; vitamin D3; n-3 fatty acids

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Salivary insulin responses

  3 hours

• Subjective appetite rating

  3 hours

• Blood pressure

  3 hours

Study Arms (6)

Glucose as reference food

EXPERIMENTAL

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

Control juice

EXPERIMENTAL

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

Juice containing vitamin D3

EXPERIMENTAL

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

Juice containing n-3 polyunsaturated fatty acids (PUFA)

EXPERIMENTAL

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

Juice containing probiotics

EXPERIMENTAL

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

Juice containing probiotics, vitamin D3, and n-3 PUFA

EXPERIMENTAL

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

Interventions

Glucose as reference food OTHER

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.

Also known as: reference drink D-Glucose

Glucose as reference food

Control juice OTHER

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.

Control juice

Juice with vitamin D3 OTHER

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.

Also known as: Vitamin D3

Juice containing vitamin D3

Juice with n-3 fatty acids OTHER

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.

Also known as: n-3 fatty acids

Juice containing n-3 polyunsaturated fatty acids (PUFA)

Juice with probiotics OTHER

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.

Also known as: probiotics

Juice containing probiotics

Juice with probiotics, vitamin D3, and n-3 fatty acids OTHER

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.

Also known as: probiotics, vitamin D-3, and n-3 fatty acids

Juice containing probiotics, vitamin D3, and n-3 PUFA

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Agricultural University of Athens: lead

Study Sites (1)

Agricultural University of Athens

Athens, Attica, 11855, Greece

Location

MeSH Terms

Conditions

Feeding and Eating Disorders; Insulin Resistance

Interventions

Glucose; Cholecalciferol; Fatty Acids, Omega-3; Probiotics

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Emilia Papakonstantinou, PhD

  Agricultural University of Athens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double blind (both the investigator and the participant was not aware of the treatment)
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Crossover assignment

Study Record Dates

• First Submitted: January 19, 2023
• First Posted: January 27, 2023
• Study Start: November 2, 2022
• Primary Completion: December 20, 2022
• Study Completion: January 25, 2023
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)