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

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

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.

Study Overview

• Status: Completed
• Conditions: Subjective Appetite
• Intervention / Treatment: Behavioral: Orange juice with vitamin D3, n-3 fatty acids, and probiotics as preload

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Attica
    • Athens, Attica, Greece, 11855
      • Agricultural University of Athens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Capillary blood glucose responses	Clinically significant change in capillary blood glucose levels between the two interventions.	7 hours
Blood pressure	Clinically significant change in systolic and diastolic blood pressure between the two interventions.	7 hours

Collaborators and Investigators

• Sponsor: Agricultural University of Athens
• Investigators: Principal Investigator: Aimilia Papakonstantinou, PhD, Agricultural University of Athens

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2023
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): September 15, 2023

Study Registration Dates

• First Submitted: June 24, 2023
• First Submitted That Met QC Criteria: June 30, 2023
• First Posted (Actual): July 3, 2023

Study Record Updates

• Last Update Posted (Actual): June 11, 2024
• Last Update Submitted That Met QC Criteria: June 9, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: probiotics; n-3 fatty acids; vitamin D3; feeding behavior; subjective appetite; glycemic responses; enriched juice
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: HRBD 73/04.10.2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No