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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Subjective Appetite

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Orange juice with vitamin D3, n-3 fatty acids, and probiotics as preload<br>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<br>* 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.<br>|
| Experimental: Control orange juice without vitamin D3, n-3 fatty acids, and probiotics as preload<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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. | 7 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Energy intake after preload and the next 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). | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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probiotics, subjective appetite, feeding behavior, glycemic responses, enriched juice, vitamin D3, n-3 fatty acids