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

Study Overview
=================
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.

Official Title
-----------------
Effect of 100% Orange Juice Intake on Subjective Appetite, Food Intake, Glycemic Response and Subjective Mood in Healthy Adults

Conditions
-----------------
Healthy, Appetite, Adult, Glycemic Response

Intervention / Treatment
-----------------
* Other: Orange juice
* Other: Orange flavoured drink
* Other: Water


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Orange juice<br>Treatment beverage | Other: Orange juice<br>* Matched for volume (240 mL/ 8 oz) of other test beverages. 100% orange juice.<br>|
| Experimental: Orange flavoured drink<br>Treatment beverage | Other: Orange flavoured drink<br>* Matched for volume (240 mL/ 8 oz) of other test beverages. Orange flavoured drink<br>|
| Experimental: Water<br>Treatment beverage | Other: Water<br>* Matched for volume (240 mL/ 8 oz) of other test beverages. Water control<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline glycemic response (acute phase) | 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). | Collected at baseline (0 minutes), 15 minutes, 30 minutes, 45 minutes, and 60 minutes post-treatment consumption | 
| Rest-of-day blood glucose concentrations | Blood glucose (mmol/L). Rest-of-day blood glucose concentrations will be determined using a Dexcom G6 CGM system. | Continuous measurements for 24 hours post-treatment consumption | 
| Ad libitum food intake | 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. | At 60 minutes post-treatment consumption | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline subjective appetite | 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. | Collected at baseline (0 minutes), 15 minutes, 30 minutes, 45 minutes, and 60 minutes post-treatment consumption | 
| Change from baseline subjective emotions and mood | 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. | Collected at baseline (0 minutes), 15 minutes, 30 minutes, 45 minutes, and 60 minutes post-treatment consumption | 
| Rest-of-the-day food intake | 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 | For the rest of the day following test session completion (1 day) | 
| Rest-of-the-day physical activity | Participants will be sent home with a rest-of-the-day physical activity recall sheet to record any activities performed. Physical activity questionnaire | For the rest of the day following test session completion (1 day) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adults, Food intake, Appetite, Blood glucose, Glycemic response, Orange juice