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

Sponsor
Ryerson University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05012046
Collaborator
(none)
40
1
3
21
1.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Orange juice
  • Other: Orange flavoured drink
  • Other: Water
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Effect of 100% Orange Juice Intake on Subjective Appetite, Food Intake, Glycemic Response and Subjective Mood in Healthy Adults
Actual Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Orange juice

Treatment beverage

Other: Orange juice
Matched for volume (240 mL/ 8 oz) of other test beverages. 100% orange juice (Tropicana Pure Premium Original, No Pulp) will provide 110 calories.

Experimental: Orange flavoured drink

Treatment beverage

Other: Orange flavoured drink
Matched for volume (240 mL/ 8 oz) of other test beverages. Orange flavoured drink (Fruité® Orange Drink) will provide 96 calories.

Experimental: Water

Treatment beverage

Other: Water
Matched for volume (240 mL/ 8 oz) of other test beverages. Control beverage (no caloric contribution).

Outcome Measures

Primary Outcome Measures

  1. 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).

  2. 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.

  3. 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.

Secondary Outcome Measures

  1. 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.

  2. 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.

  3. 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

  4. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre for Urban Innovation (CUI-109), School of Nutrition, Ryerson University Toronto Ontario Canada M5B 2K3

Sponsors and Collaborators

  • Ryerson University

Investigators

  • Principal Investigator: Nick Bellissimo, PhD, Ryerson University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nick Bellissimo, Associate Professor, Ryerson University
ClinicalTrials.gov Identifier:
NCT05012046
Other Study ID Numbers:
  • REB: 2021-177
First Posted:
Aug 19, 2021
Last Update Posted:
Oct 26, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nick Bellissimo, Associate Professor, Ryerson University

Study Results

No Results Posted as of Oct 26, 2021