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

NCT05928741 | Completed DMC

• 1 other identifier: HRBD 73/04.10.2022
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Subjective Appetite

Keywords

subjective appetite; feeding behavior; glycemic responses; enriched juice; probiotics; vitamin D3; n-3 fatty acids

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Energy intake after preload and the next 24 hours

  24 hours

Other Outcomes (2)

• Capillary blood glucose responses

  7 hours

• Blood pressure

  7 hours

Study Arms (2)

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Interventions

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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Agricultural University of Athens: lead

Study Sites (1)

Agricultural University of Athens

Athens, Attica, 11855, Greece

Location

MeSH Terms

Conditions

Feeding Behavior

Interventions

Cholecalciferol; Fatty Acids, Omega-3; Probiotics

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Aimilia Papakonstantinou, PhD

  Agricultural University of Athens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple-blind (participant, investigator, outcomes assessor)
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 24, 2023
• First Posted: July 3, 2023
• Study Start: February 2, 2023
• Primary Completion: August 1, 2023
• Study Completion: September 15, 2023
• Last Updated: June 11, 2024

Record last verified: 2024-06

Locations

GR (1)