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

Sponsor

Agricultural University of Athens (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05702359

Collaborator

(none)

Enrollment

Location

Arms

2.8

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study investigated the effects of juices consumption with biofunctional compounds (Vitamin D3 and ω3 fatty acids) and probiotics (Lacticaseibacillus casei Shirota and Lacticaseibacillus rhamnosus GG) on glucose metabolism.

Condition or Disease	Intervention/Treatment	Phase
Potential Abnormality of Glucose Tolerance Appetite Disorders	Other: Glucose as reference food Other: Control juice Other: Juice with vitamin D3 Other: Juice with ω3 fatty acids Other: Juice with probiotics Other: Juice with probiotics, vitamin D3 and ω3 fatty acids	N/A

Detailed Description

This study aimed to 1. Determine the glycemic index and glycemic load of juices consisted of pomegranate, grape, apple, and orange with biofunctional compounds (Vitamin D3 and ω3 fatty acids) and probiotics (Lacticaseibacillus casei Shirota and Lacticaseibacillus rhamnosus GG), and 2.Examine the effects of these juices on postprandial glycemic and insulinemic responses in healthy subjects.

Study Design

Study Type:

Interventional

Actual Enrollment :

11 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Crossover assignmentCrossover assignment

Masking:

Single (Investigator)

Masking Description:

single blind (investigator)

Primary Purpose:

Other

Official Title:

Acute Effects of Juice Consumption With Biofunctional Compounds (Vitamin D and ω3 Fatty Acids) and Probiotics (Lacticaseibacillus Casei Shirota and Lacticaseibacillus Rhamnosus GG) on Glucose Metabolism in Healthy Humans

Actual Study Start Date :

Nov 2, 2022

Actual Primary Completion Date :

Dec 20, 2022

Anticipated Study Completion Date :

Jan 25, 2023

Arms and Interventions

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; and 50g available carbohydrates from control juice (consisted of pomegranate, grape, apple and orange), and juice containing vitamin D3, juice containing ω3 fatty acids, juice containing probiotics and juice containing probiotics, vitamin D3 and ω3 fatty acids, each tested once, in different visits along with 300mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90, 120, 150 and 180min and salivary insulin 0, 15, 30, 45, 60, 90, 120 and 180min after food consumption. The first glucose and salivary insulin sample were taken exactly 15min after the first bite of food or drink.	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 take at baseline, 15, 30, 45, 60, 90, 120, and 180 min. 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 take at baseline, 15, 30, 45, 60, 90, 120, and 180 min. 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 take at baseline, 15, 30, 45, 60, 90, 120, and 180 min. Other: Juice with ω3 fatty acids Eleven healthy, normal body weight subjects after 10-14hr fast, consumed 50g available carbohydrated from juice (consisted of pomegranate, grape, apple and orange) containing ω3 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 take at baseline, 15, 30, 45, 60, 90, 120, and 180 min. Other: Juice with probiotics Eleven healthy, normal body weight subjects after 10-14hr fast, consumed 50g available carbohydrated 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 take at baseline, 15, 30, 45, 60, 90, 120, and 180 min. Other: Juice with probiotics, vitamin D3 and ω3 fatty acids Eleven healthy, normal body weight subjects after 10-14hr fast, consumed 50g available carbohydrated from juice (consisted of pomegranate, grape, apple and orange) containing probiotics, vitamin D3 and ω3 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 take at baseline, 15, 30, 45, 60, 90, 120, and 180 min.
Experimental: Control juice 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; and 50g available carbohydrates from control juice (consisted of pomegranate, grape, apple and orange), and juice containing vitamin D3, juice containing ω3 fatty acids, juice containing probiotics and juice containing probiotics, vitamin D3 and ω3 fatty acids, each tested once, in different visits along with 300mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90, 120, 150 and 180min and salivary insulin 0, 15, 30, 45, 60, 90, 120 and 180min after food consumption. The first glucose and salivary insulin sample were taken exactly 15min after the first bite of food or drink.	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 take at baseline, 15, 30, 45, 60, 90, 120, and 180 min. 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 take at baseline, 15, 30, 45, 60, 90, 120, and 180 min. 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 take at baseline, 15, 30, 45, 60, 90, 120, and 180 min. Other: Juice with ω3 fatty acids Eleven healthy, normal body weight subjects after 10-14hr fast, consumed 50g available carbohydrated from juice (consisted of pomegranate, grape, apple and orange) containing ω3 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 take at baseline, 15, 30, 45, 60, 90, 120, and 180 min. Other: Juice with probiotics Eleven healthy, normal body weight subjects after 10-14hr fast, consumed 50g available carbohydrated 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 take at baseline, 15, 30, 45, 60, 90, 120, and 180 min. Other: Juice with probiotics, vitamin D3 and ω3 fatty acids Eleven healthy, normal body weight subjects after 10-14hr fast, consumed 50g available carbohydrated from juice (consisted of pomegranate, grape, apple and orange) containing probiotics, vitamin D3 and ω3 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 take 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 D-glucose, tested two times, in different visits as reference food; and 50g available carbohydrates from control juice (consisted of pomegranate, grape, apple, and orange), and juice containing vitamin D3, juice containing ω3 fatty acids, juice containing probiotics and juice containing probiotics, vitamin D3, and ω3 fatty acids, each tested once, in different visits along with 300mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90, 120, 150 and 180 min and salivary insulin 0, 15, 30, 45, 60, 90, 120 and 180 min after food consumption. The first glucose and salivary insulin sample were taken exactly 15min after the first bite of food or drink.	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 take at baseline, 15, 30, 45, 60, 90, 120, and 180 min. 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 take at baseline, 15, 30, 45, 60, 90, 120, and 180 min. 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 take at baseline, 15, 30, 45, 60, 90, 120, and 180 min. Other: Juice with ω3 fatty acids Eleven healthy, normal body weight subjects after 10-14hr fast, consumed 50g available carbohydrated from juice (consisted of pomegranate, grape, apple and orange) containing ω3 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 take at baseline, 15, 30, 45, 60, 90, 120, and 180 min. Other: Juice with probiotics Eleven healthy, normal body weight subjects after 10-14hr fast, consumed 50g available carbohydrated 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 take at baseline, 15, 30, 45, 60, 90, 120, and 180 min. Other: Juice with probiotics, vitamin D3 and ω3 fatty acids Eleven healthy, normal body weight subjects after 10-14hr fast, consumed 50g available carbohydrated from juice (consisted of pomegranate, grape, apple and orange) containing probiotics, vitamin D3 and ω3 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 take at baseline, 15, 30, 45, 60, 90, 120, and 180 min.
Experimental: Juice containing ω3 fatty acids 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; and 50g available carbohydrates from control juice (consisted of pomegranate, grape, apple and orange), and juice containing vitamin D3, juice containing ω3 fatty acids, juice containing probiotics and juice containing probiotics, vitamin D3 and ω3 fatty acids, each tested once, in different visits along with 300mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90, 120, 150 and 180min and salivary insulin 0, 15, 30, 45, 60, 90, 120 and 180min after food consumption. The first glucose and salivary insulin sample were taken exactly 15min after the first bite of food or drink.	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 take at baseline, 15, 30, 45, 60, 90, 120, and 180 min. 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 take at baseline, 15, 30, 45, 60, 90, 120, and 180 min. 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 take at baseline, 15, 30, 45, 60, 90, 120, and 180 min. Other: Juice with ω3 fatty acids Eleven healthy, normal body weight subjects after 10-14hr fast, consumed 50g available carbohydrated from juice (consisted of pomegranate, grape, apple and orange) containing ω3 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 take at baseline, 15, 30, 45, 60, 90, 120, and 180 min. Other: Juice with probiotics Eleven healthy, normal body weight subjects after 10-14hr fast, consumed 50g available carbohydrated 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 take at baseline, 15, 30, 45, 60, 90, 120, and 180 min. Other: Juice with probiotics, vitamin D3 and ω3 fatty acids Eleven healthy, normal body weight subjects after 10-14hr fast, consumed 50g available carbohydrated from juice (consisted of pomegranate, grape, apple and orange) containing probiotics, vitamin D3 and ω3 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 take at baseline, 15, 30, 45, 60, 90, 120, and 180 min.
Experimental: Juice containing probiotics 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; and 50g available carbohydrates from control juice (consisted of pomegranate, grape, apple and orange), and juice containing vitamin D3, juice containing ω3 fatty acids, juice containing probiotics and juice containing probiotics, vitamin D3 and ω3 fatty acids, each tested once, in different visits along with 300mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90, 120, 150 and 180min and salivary insulin 0, 15, 30, 45, 60, 90, 120 and 180min after food consumption. The first glucose and salivary insulin sample were taken exactly 15min after the first bite of food or drink.	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 take at baseline, 15, 30, 45, 60, 90, 120, and 180 min. 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 take at baseline, 15, 30, 45, 60, 90, 120, and 180 min. 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 take at baseline, 15, 30, 45, 60, 90, 120, and 180 min. Other: Juice with ω3 fatty acids Eleven healthy, normal body weight subjects after 10-14hr fast, consumed 50g available carbohydrated from juice (consisted of pomegranate, grape, apple and orange) containing ω3 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 take at baseline, 15, 30, 45, 60, 90, 120, and 180 min. Other: Juice with probiotics Eleven healthy, normal body weight subjects after 10-14hr fast, consumed 50g available carbohydrated 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 take at baseline, 15, 30, 45, 60, 90, 120, and 180 min. Other: Juice with probiotics, vitamin D3 and ω3 fatty acids Eleven healthy, normal body weight subjects after 10-14hr fast, consumed 50g available carbohydrated from juice (consisted of pomegranate, grape, apple and orange) containing probiotics, vitamin D3 and ω3 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 take at baseline, 15, 30, 45, 60, 90, 120, and 180 min.
Experimental: Juice containing probiotics, vitamin D3 and ω3 fatty acids 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; and 50g available carbohydrates from control juice (consisted of pomegranate, grape, apple and orange), and juice containing vitamin D3, juice containing ω3 fatty acids, juice containing probiotics and juice containing probiotics, vitamin D3 and ω3 fatty acids, each tested once, in different visits along with 300mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90, 120, 150 and 180min and salivary insulin 0, 15, 30, 45, 60, 90, 120 and 180min after food consumption. The first glucose and salivary insulin sample were taken exactly 15min after the first bite of food or drink.	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 take at baseline, 15, 30, 45, 60, 90, 120, and 180 min. 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 take at baseline, 15, 30, 45, 60, 90, 120, and 180 min. 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 take at baseline, 15, 30, 45, 60, 90, 120, and 180 min. Other: Juice with ω3 fatty acids Eleven healthy, normal body weight subjects after 10-14hr fast, consumed 50g available carbohydrated from juice (consisted of pomegranate, grape, apple and orange) containing ω3 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 take at baseline, 15, 30, 45, 60, 90, 120, and 180 min. Other: Juice with probiotics Eleven healthy, normal body weight subjects after 10-14hr fast, consumed 50g available carbohydrated 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 take at baseline, 15, 30, 45, 60, 90, 120, and 180 min. Other: Juice with probiotics, vitamin D3 and ω3 fatty acids Eleven healthy, normal body weight subjects after 10-14hr fast, consumed 50g available carbohydrated from juice (consisted of pomegranate, grape, apple and orange) containing probiotics, vitamin D3 and ω3 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 take at baseline, 15, 30, 45, 60, 90, 120, and 180 min.

Outcome Measures

Primary Outcome Measures

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

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
Subjective appetite rating [3 hours]
Useful change in subjective appetite using visual analogue scales with a score 0 to10 (given in the form of booklet, one scale per page) at baseline, 15, 30, 45, 60, 90, 120, 150 and 180 min.
Blood pressure [3 hours]
Useful change in systolic and diastolic blood pressure before and 3hr after consumption of the juices.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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