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

Subjective Appetite Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05928741
• Other study ID #: HRBD 73/04.10.2022
• Status: Completed
• Phase: N/A
• Start date: February 2, 2023
• Est. completion date: September 15, 2023

Study information

• Verified date: June 2024
• Source: Agricultural University of Athens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 15, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Subjective Appetite

Intervention

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.

Locations

Country	Name	City	State
Greece	Agricultural University of Athens	Athens	Attica

Sponsors (1)

Lead Sponsor	Collaborator
Agricultural University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Capillary blood glucose responses	Clinically significant change in capillary blood glucose levels between the two interventions.	7 hours
Other	Blood pressure	Clinically significant change in systolic and diastolic blood pressure between the two interventions.	7 hours
Primary	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	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