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Completed

NCT Number: NCT05012046

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

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.

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Key information

Conditions

Healthy Adult Appetite Glycemic Response

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Urban Innovation (CUI-109), School of Nutrition, Ryerson University

Toronto, Ontario, M5B 2K3, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Orange juice

Other

Matched for volume (240 mL/ 8 oz) of other test beverages. 100% orange juice.

Orange flavoured drink

Other

Matched for volume (240 mL/ 8 oz) of other test beverages. Orange flavoured drink

Water

Other

Matched for volume (240 mL/ 8 oz) of other test beverages. Water control

Primary outcomes

  1. Change from baseline glycemic response (acute phase)

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Change from baseline subjective appetite

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Toronto Metropolitan University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 19, 2021
Registry last updated
Mar 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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