Clinical trial NCT05012046: Effect of 100% Orange Juice on Food Intake and Glycemic Response in Adults
Official title: Effect of 100% Orange Juice Intake on Subjective Appetite, Food Intake, Glycemic Response and Subjective Mood in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Adult
Glycemic Response
Appetite
Keywords: Food intake
Appetite
Blood glucose
Glycemic response
Orange juice
Adults
Lead sponsor: Toronto Metropolitan University
Sponsor class: OTHER
First posted: 2021-08-19
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline glycemic response (acute phase)
timeFrame: Collected at baseline (0 minutes), 15 minutes, 30 minutes, 45 minutes, and 60 minutes post-treatment consumption
measure: Rest-of-day blood glucose concentrations
timeFrame: Continuous measurements for 24 hours post-treatment consumption
measure: Ad libitum food intake
timeFrame: At 60 minutes post-treatment consumption
Secondary outcomes:
measure: Change from baseline subjective appetite
timeFrame: Collected at baseline (0 minutes), 15 minutes, 30 minutes, 45 minutes, and 60 minutes post-treatment consumption
measure: Change from baseline subjective emotions and mood
timeFrame: Collected at baseline (0 minutes), 15 minutes, 30 minutes, 45 minutes, and 60 minutes post-treatment consumption
measure: Rest-of-the-day food intake
timeFrame: For the rest of the day following test session completion (1 day)
measure: Rest-of-the-day physical activity
timeFrame: For the rest of the day following test session completion (1 day)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Urban Innovation (CUI-109), School of Nutrition, Ryerson University
state: Ontario
Study officials:
affiliation: Toronto Metropolitan University
name: Nick Bellissimo, PhD
role: PRINCIPAL_INVESTIGATOR
References: