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

Sponsor

Agricultural University of Athens (Other)

Overall Status

Recruiting

CT.gov ID

NCT05928741

Collaborator

(none)

Enrollment

Location

Arms

4.9

Anticipated Duration (Months)

9.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Subjective Appetite	Behavioral: Orange juice with vitamin D3, n-3 fatty acids, and probiotics as preload	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Masking Description:

Double-blind (both the investigator and the participant were not aware of the treatment)

Primary Purpose:

Other

Official Title:

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 Healthy Adults

Actual Study Start Date :

Feb 2, 2023

Anticipated Primary Completion Date :

Jun 25, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: 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.
Experimental: 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.	Behavioral: 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.

Arm

Intervention/Treatment

Experimental: 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.

Behavioral: 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.

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

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

Outcome Measures

Primary Outcome Measures

Subjective appetite rating [7 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 100 mm and width of 3 desktop publishing points, that 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 "100" as numerical anchors below the left and right endpoints, respectively.

Secondary Outcome Measures

Energy intake after preload and the next 24 hours [24 hours]
Clinically significant difference in energy intake (ad libitum lunch) two hours after the two different preloads consumption, as well as the next 24 hours after the intervention (actual weighing of foods consumed and leftovers, and 24-hour recall).

Other Outcome Measures

Capillary blood glucose responses [7 hours]
Clinically significant change in capillary blood glucose levels between the two interventions.
Blood pressure [7 hours]
Clinically significant change in systolic and diastolic blood pressure between the two interventions.

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-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