Effect of 100% Orange Juice on Food Intake and Glycemic Response in Adults

Not Applicable

Completed

• Conditions: Healthy; Glycemic Response; Adult; Appetite
• Interventions: Other: Orange juice; Other: Orange flavoured drink; Other: Water

• Registration Number: NCT05012046
• Lead Sponsor: Toronto Metropolitan University

Brief Summary

The purpose of this study is to determine the effects of 100% orange juice on short-term food intake (FI), satiety, post-prandial glycemia and mood in healthy adults. We hypothesize that the consumption of 100% orange juice in the pre-meal environment will improve satiety signals and mood, and suppress FI through its effect on post-prandial glycemia.

Detailed Description

A randomized within-subjects repeated measures design will be employed. Study visits will take place in the morning, separated one-week apart. At each session, participants will consume one of three treatments: 1) 100% orange juice; 2) orange flavoured drink; or 3) water. Glycemic response will be measured for 60 minutes (baseline (0 minutes), 15 minutes, 30 minutes, 45 minutes and 60 minutes) post-treatment via finger prick. Blood glucose measures will also be provided over 24 hours via a Dexcom G6 continuous glucose monitoring (CGM) device. Subjective appetite, emotions and mood will be measured for 90 minutes min (baseline (0 minutes), 15 minutes, 30 minutes, 45 minutes, 60 minutes and 90 minutes) post-treatment. At 60 minutes, participants will consume an ad libitum pizza lunch to evaluate food intake. After lunch, participants will be sent home with a rest-of-the-day food intake sheet to record their snacks, meals, and beverages, as well as a physical activity log to record their physical activity for the rest of the day following test session completion.

Study Timeline

• Study First Submitted: 2021-08-11
• Study First Submitted QC: 2021-08-17
• Study First Posted: 2021-08-19
• Study Start: 2021-10-01
• Primary Completion: 2022-12-22
• Study Completion: 2022-12-22
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-02
• Last Update Posted: 2023-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• aged 18-45 years;
• within the healthy body mass index (BMI) range for adults of 18.5-24.9 kg/m2.

Exclusion Criteria

• individuals who are dieting;
• restrained eaters;
• breakfast skippers;
• those who dislike breakfast or lunch treatment foods;
• those taking medication;
• individuals with any metabolic disorders or significant weight fluctuations.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Orange juice	Orange juice	Treatment beverage
Orange flavoured drink	Orange flavoured drink	Treatment beverage
Water	Water	Treatment beverage

Primary Outcome Measures

Name	Time	Method
Rest-of-day blood glucose concentrations	Continuous measurements for 24 hours post-treatment consumption	Blood glucose (mmol/L). Rest-of-day blood glucose concentrations will be determined using a Dexcom G6 CGM system.
Ad libitum food intake	At 60 minutes post-treatment consumption	Lunch pizza meal. Food intake will be determined by weighing the meal before and after serving. The net weight of the test meal will be converted to calories.
Change from baseline glycemic response (acute phase)	Collected at baseline (0 minutes), 15 minutes, 30 minutes, 45 minutes, and 60 minutes post-treatment consumption	Blood glucose (mmol/L). Three drops of blood from the finger will be collected at each time point using a single-use, auto-disabling lancet device and sodium fluoride/potassium oxalate capillary blood collection tubes. Blood glucose will be measured using a YSI 2900D Biochemistry Analyzer (YSI Inc., Yellow Springs, OH).

Secondary Outcome Measures

Name	Time	Method
Rest-of-the-day physical activity	For the rest of the day following test session completion (1 day)	Participants will be sent home with a rest-of-the-day physical activity recall sheet to record any activities performed.; Physical activity questionnaire
Change from baseline subjective appetite	Collected at baseline (0 minutes), 15 minutes, 30 minutes, 45 minutes, and 60 minutes post-treatment consumption	Measured using visual analogue scales (VAS). Each VAS is a 100 mm line where they will place a pencil mark to describe their feelings. Questions will include desire to eat, fullness, hunger, and prospective food consumption. Individual questions will be used to form a composite score.
Change from baseline subjective emotions and mood	Collected at baseline (0 minutes), 15 minutes, 30 minutes, 45 minutes, and 60 minutes post-treatment consumption	Measured using visual analogue scales. Each VAS is a 100 mm line where they will place a pencil mark to describe their feelings. Questions will measure aggression, anger, excitement, disappointment, frustration, alertness, sadness, tension, effort, happiness, weariness, calmness, sleepiness, and wellness. Individual questions will be used to form a composite score.
Rest-of-the-day food intake	For the rest of the day following test session completion (1 day)	Participants will be sent home with a rest-of-the-day food intake recall sheet to record their snacks, meals, and beverages.; Rest of day food log

Trial Locations

Locations (1)

Centre for Urban Innovation (CUI-109), School of Nutrition, Ryerson University; 🇨🇦 Toronto, Ontario, Canada