HealthyNCT05012046
Effect of 100% Orange Juice on Food Intake and Glycemic Response in Adults
A study testing Orange juice, Orange flavoured drink and Water in people with Healthy and Adult, run by Toronto Metropolitan University at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Adult, Glycemic Response
- What is being tested?
- Orange juice, Orange flavoured drink and Water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2021to 22 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- aged 18-45 years;
- within the healthy body mass index (BMI) range for adults of 18.5-24.9 kg/m2.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre for Urban Innovation (CUI-109), School of Nutrition, Ryerson University
Toronto, Ontario, M5B 2K3
About this study
Official title: Effect of 100% Orange Juice Intake on Subjective Appetite, Food Intake, Glycemic Response and Subjective Mood in Healthy 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.
Read the 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.
- Conditions
- Healthy, Adult, Glycemic Response, Appetite
- Being tested
- Orange juice, Orange flavoured drink, Water
- Keywords
- Food intake, Appetite, Blood glucose, Glycemic response, Orange juice, Adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orange juiceOther
Matched for volume (240 mL/ 8 oz) of other test beverages. 100% orange juice.
Orange flavoured drinkOther
Matched for volume (240 mL/ 8 oz) of other test beverages. Orange flavoured drink
WaterOther
Matched for volume (240 mL/ 8 oz) of other test beverages. Water control
| Study group | Role | What they receive |
|---|---|---|
| Orange juice | Experimental | Treatment beverage Receives: Other: Orange juice |
| Orange flavoured drink | Experimental | Treatment beverage Receives: Other: Orange flavoured drink |
| Water | Experimental | Treatment beverage Receives: Other: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: At 60 minutes post-treatment consumption
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: For the rest of the day following test session completion (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start1 Oct 2021
- Primary completion22 Dec 2022
- Study completion22 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toronto Metropolitan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nick Bellissimo, Toronto Metropolitan University
- Investigators
- Nick Bellissimo, PhD, Principal investigator, Toronto Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05012046
- Sponsor's protocol ID
- REB: 2021-177
- Status last verified
- Mar 2023
- First submitted
- 11 Aug 2021
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 100% Orange Juice Intake on Subjective Appetite, Food Intake, Glycemic Response and Subjective Mood in Healthy Adults
- ClinicalTrials.gov ID
- NCT05012046
- Acronym / sponsor ID
- REB: 2021-177
- Conditions
- Healthy, Adult, Glycemic Response, Appetite
- Keywords
- Food intake, Appetite, Blood glucose, Glycemic response, Orange juice, Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Toronto Metropolitan UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 22 Dec 2022 (actual)
- Study completion
- 22 Dec 2022 (actual)
- First posted
- 19 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Orange juice | Experimental | Other: Orange juiceTreatment beverage |
| Orange flavoured drink | Experimental | Other: Orange flavoured drinkTreatment beverage |
| Water | Experimental | Other: WaterTreatment beverage |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- aged 18-45 years;
- within the healthy body mass index (BMI) range for adults of 18.5-24.9 kg/m2.
Key exclusion criteria (6 listed)
- individuals who are dieting;
- restrained eaters;
- breakfast skippers;
- those who dislike breakfast or lunch treatment foods;
- those taking medication;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orange juiceMatched for volume (240 mL/ 8 oz) of other test beverages. 100% orange juice. | Other | Orange juice |
| Orange flavoured drinkMatched for volume (240 mL/ 8 oz) of other test beverages. Orange flavoured drink | Other | Orange flavoured drink |
| WaterMatched for volume (240 mL/ 8 oz) of other test beverages. Water control | Other | Water |
Primary outcome
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).
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.
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.
4 secondary outcomes
Change from baseline subjective appetite
Time frame: Collected at baseline (0 minutes), 15 minutes, 30 minutes, 45 minutes, and 60 minutes post-treatment consumption
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
Rest-of-the-day food intake
Time frame: For the rest of the day following test session completion (1 day)
Rest-of-the-day physical activity
Time frame: For the rest of the day following test session completion (1 day)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nick Bellissimo, PhD principal investigator
Toronto Metropolitan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orange juice, Orange flavoured drink and Water in people with Healthy and Adult, run by Toronto Metropolitan University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2023.