Short-term Effects of Juice Consumption With Biofunctional Compounds and Probiotics on Subjective Appetite

NCT ID: NCT05928741

Last Updated: 2024-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-02
• Study Completion Date: 2023-09-15

Brief Summary

This study investigated the short-term effects of fruit juice enriched with vitamin D3, n-3 fatty acids, and probiotics on subjective appetite, energy intake, and glycemic responses, in both normal-weight and overweight, healthy adults.

Detailed Description

This study aimed to 1. Assess the subjective appetite of participants after the consumption of fruit juice (100% orange) enriched with vitamin D3, n-3 fatty acids, and probiotics compared to regular fruit juice (without any fortification), and 2. Examine the short-term effects of enriched fruit juice compared to regular fruit juice on glycemic responses and blood pressure, in both normal-weight and overweight healthy adults

Conditions

Subjective Appetite

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Orange juice with vitamin D3, n-3 fatty acids, and probiotics as preload

Twenty-three healthy adults with normal weight and twenty-three healthy adults with overweight consumed a standardized breakfast after a 12-hour fast. Two hours later they were given 50 g of available carbohydrates from the two preloads (enriched orange juice or control orange juice) in a random order, and 3 hours after the preload they were offered an ad libitum lunch. Foods were weighed at the time of serving and any leftovers were weighed again after lunch to determine the amount of food consumed. There was a washout period of at least one week between the two visits. Fingertip capillary blood glucose samples were collected at baseline and at several time points after food intake. Visual analog scales (VAS) of 100 mm were collected to assess subjective appetite. Blood pressure was measured at several time-points.

Group Type: EXPERIMENTAL

Orange juice with vitamin D3, n-3 fatty acids, and probiotics as preload

Intervention Type: BEHAVIORAL

Twenty-three healthy adults with normal weight and twenty-three healthy adults with overweight consumed a standardized breakfast consisting of 2 slices of white bread and honey (350 kcal in total) after a 12-hour fast. Two hours later they were offered 347 mL of the enriched orange juice (containing 50 g available carbohydrates), and 3 hours after the preload they were offered an ad libitum lunch (chicken breast with white rice). Foods were weighed at the time of serving and any leftovers were weighed again after lunch to determine the amount of food consumed. Fingertip capillary blood glucose samples and visual analog scales (VAS) of 100 mm were collected at baseline and at 60, 120, 135, 150, 180, 210, 240, 270, 300, 330, 360, 390, and 420 minutes after breakfast consumption. Blood pressure was measured at baseline, 120, 300, and 420 minutes.

Control orange juice without vitamin D3, n-3 fatty acids, and probiotics as preload

Twenty-three healthy adults with normal weight and twenty-three healthy adults with overweight consumed a standardized breakfast after a 12-hour fast. Two hours later they were given 50 g of available carbohydrates from the two preloads (enriched orange juice or control orange juice) in a random order, and 3 hours after the preload they were offered an ad libitum lunch. Foods were weighed at the time of serving and any leftovers were weighed again after lunch to determine the amount of food consumed. There was a washout period of at least one week between the two visits. Fingertip capillary blood glucose samples were collected at baseline and at several time points after food intake. Visual analog scales (VAS) of 100 mm were collected to assess subjective appetite. Blood pressure was measured at several time-points.

Group Type: EXPERIMENTAL

Orange juice with vitamin D3, n-3 fatty acids, and probiotics as preload

Intervention Type: BEHAVIORAL

Twenty-three healthy adults with normal weight and twenty-three healthy adults with overweight consumed a standardized breakfast consisting of 2 slices of white bread and honey (350 kcal in total) after a 12-hour fast. Two hours later they were offered 347 mL of the enriched orange juice (containing 50 g available carbohydrates), and 3 hours after the preload they were offered an ad libitum lunch (chicken breast with white rice). Foods were weighed at the time of serving and any leftovers were weighed again after lunch to determine the amount of food consumed. Fingertip capillary blood glucose samples and visual analog scales (VAS) of 100 mm were collected at baseline and at 60, 120, 135, 150, 180, 210, 240, 270, 300, 330, 360, 390, and 420 minutes after breakfast consumption. Blood pressure was measured at baseline, 120, 300, and 420 minutes.

Interventions

Orange juice with vitamin D3, n-3 fatty acids, and probiotics as preload

Twenty-three healthy adults with normal weight and twenty-three healthy adults with overweight consumed a standardized breakfast consisting of 2 slices of white bread and honey (350 kcal in total) after a 12-hour fast. Two hours later they were offered 347 mL of the enriched orange juice (containing 50 g available carbohydrates), and 3 hours after the preload they were offered an ad libitum lunch (chicken breast with white rice). Foods were weighed at the time of serving and any leftovers were weighed again after lunch to determine the amount of food consumed. Fingertip capillary blood glucose samples and visual analog scales (VAS) of 100 mm were collected at baseline and at 60, 120, 135, 150, 180, 210, 240, 270, 300, 330, 360, 390, and 420 minutes after breakfast consumption. Blood pressure was measured at baseline, 120, 300, and 420 minutes.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Healthy Non-diabetic men and women Body mass index between 18.5 and 29.9 kg/m2

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Agricultural University of Athens

OTHER

Sponsor Role: lead

Responsible Party

Aimilia Papakonstantinou

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aimilia Papakonstantinou, PhD

Role: PRINCIPAL_INVESTIGATOR

Agricultural University of Athens

Locations

Agricultural University of Athens

Athens, Attica, Greece

Countries

Greece

Other Identifiers

HRBD 73/04.10.2022

Identifier Type: -

Identifier Source: org_study_id