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

Primary Purpose

Potential Abnormality of Glucose Tolerance, Appetite Disorders

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Glucose as reference food
Control juice
Juice with vitamin D3
Juice with n-3 fatty acids
Juice with probiotics
Juice with probiotics, vitamin D3, and n-3 fatty acids
Sponsored by
Agricultural University of Athens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Potential Abnormality of Glucose Tolerance focused on measuring blood glucose, insulin, glycemic index, glycemic load, juices, probiotics, vitamin D3, n-3 fatty acids

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Agricultural University of Athens

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Glucose as reference food

Control juice

Juice containing vitamin D3

Juice containing n-3 polyunsaturated fatty acids (PUFA)

Juice containing probiotics

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

Arm Description

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 19, 2023
Last Updated
May 8, 2023
Sponsor
Agricultural University of Athens
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1. Study Identification

Unique Protocol Identification Number
NCT05702359
Brief Title
Acute Effects of Juice Consumption With Biofunctional Compounds and Probiotics on Glucose Metabolism
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 2, 2022 (Actual)
Primary Completion Date
December 20, 2022 (Actual)
Study Completion Date
January 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Agricultural University of Athens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Potential Abnormality of Glucose Tolerance, Appetite Disorders
Keywords
blood glucose, insulin, glycemic index, glycemic load, juices, probiotics, vitamin D3, n-3 fatty acids

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Crossover assignment
Masking
ParticipantInvestigator
Masking Description
double blind (both the investigator and the participant was not aware of the treatment)
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glucose as reference food
Arm Type
Experimental
Arm Description
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.
Arm Title
Control juice
Arm Type
Experimental
Arm Description
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.
Arm Title
Juice containing vitamin D3
Arm Type
Experimental
Arm Description
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.
Arm Title
Juice containing n-3 polyunsaturated fatty acids (PUFA)
Arm Type
Experimental
Arm Description
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.
Arm Title
Juice containing probiotics
Arm Type
Experimental
Arm Description
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.
Arm Title
Juice containing probiotics, vitamin D3, and n-3 PUFA
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Glucose as reference food
Other Intervention Name(s)
reference drink D-Glucose
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control juice
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Juice with vitamin D3
Other Intervention Name(s)
Vitamin D3
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Juice with n-3 fatty acids
Other Intervention Name(s)
n-3 fatty acids
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Juice with probiotics
Other Intervention Name(s)
probiotics
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Juice with probiotics, vitamin D3, and n-3 fatty acids
Other Intervention Name(s)
probiotics, vitamin D-3, and n-3 fatty acids
Intervention Description
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.
Primary Outcome Measure Information:
Title
Capillary blood glucose responses
Description
Clinically useful change in blood glucose, defined as the restoration of glucose within normal limits during the 3hr glucose tolerance test
Time Frame
3 hours
Secondary Outcome Measure Information:
Title
Salivary insulin responses
Description
Clinically useful change in salivary insulin, defined as the restoration of insulin within normal limits during the 3hr glucose torelance test
Time Frame
3 hours
Title
Subjective appetite rating
Description
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.
Time Frame
3 hours
Title
Blood pressure
Description
Useful change in systolic and diastolic blood pressure before and 3hr after consumption of the juices.
Time Frame
3 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emilia Papakonstantinou, PhD
Organizational Affiliation
Agricultural University of Athens
Official's Role
Principal Investigator
Facility Information:
Facility Name
Agricultural University of Athens
City
Athens
State/Province
Attica
ZIP/Postal Code
11855
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
No

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

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