ObesityNCT01595919
A Comparison of Beverages Consumed Within a Meal to Satiation on Meal-time Food Intake and Post-meal Appetite and Glycemic Response in Healthy Young Adults
A study testing Nutritional Intervention in people with Obesity and Hyperglycemia, run by University of Toronto at 1 site in Canada.
Trial summary
The objective of the current study is to determine the effects of an ad libitum intake of 1% milk, fruit juice, regular cola, diet cola and water, as part of a pizza meal, on meal food intake, appetite and postprandial blood glucose in healthy men and women. Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Hyperglycemia
- What is being tested?
- Nutritional Intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2011to Dec 2011
- 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 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy men and women
- age 20-30 years
- BMI between 20-24.9 kg/m^2
Who cannot join
- breakfast skippers
- diabetes or any metabolic diseases
- lactose intolerance or allergies to milk
- taking medications
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Toronto, Department of Nutritional Sciences
Toronto, Ontario, M5S 3E2
About this study
The objective of the current study is to determine the effects of an ad libitum intake of 1% milk, fruit juice, regular cola, diet cola and water, as part of a pizza meal, on meal food intake, appetite and postprandial blood glucose in healthy men and women. We hypothesize that 1% milk will reduce food intake and result in better post-meal glycemic response compared to the other beverages.
- Conditions
- Obesity, Hyperglycemia
- Being tested
- Nutritional Intervention
- Medical subject headings
- Obesity, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional InterventionOther
Ad libitum amounts of beverage at a meal
| Study group | Role | What they receive |
|---|---|---|
| 1% Milk | Experimental | Not described Receives: Other: Nutritional Intervention |
| Regular Cola | Experimental | Not described Receives: Other: Nutritional Intervention |
| Diet cola | Experimental | Not described Receives: Other: Nutritional Intervention |
| Orange juice | Experimental | Not described Receives: Other: Nutritional Intervention |
| Water | Placebo comparator | Not described Receives: Other: Nutritional Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food Intake
Measurement of energy intake during an ad libitum test meal
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2012 (estimated)
- Study startApr 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, G. Harvey Anderson, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01595919
- Sponsor's protocol ID
- Mixed Meal Milk Study
- Status last verified
- Jun 2012
- First submitted
- 8 May 2012
- Last updated
- 15 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
El Khoury D, Panahi S, Luhovyy BL, Douglas Goff H, Harvey Anderson G. Interaction of mealtime ad libitum beverage and food intake with meal advancement in healthy young men and women. Physiol Behav. 2015 May 1;143:39-44. doi: 10.1016/j.physbeh.2015.02.023. Epub 2015 Feb 18.
PubMed 25700893
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Beverages Consumed Within a Meal to Satiation on Meal-time Food Intake and Post-meal Appetite and Glycemic Response in Healthy Young Adults
- ClinicalTrials.gov ID
- NCT01595919
- Acronym / sponsor ID
- Mixed Meal Milk Study
- Conditions
- Obesity, Hyperglycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 10 May 2012 (estimated)
- 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 objective of the current study is to determine the effects of an ad libitum intake of 1% milk, fruit juice, regular cola, diet cola and water, as part of a pizza meal, on meal food intake, appetite and postprandial blood glucose in healthy men and women. We hypothesize that 1% milk will reduce food intake and result in better post-meal glycemic response compared to the other beverages.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1% Milk | Experimental | Other: Nutritional Intervention |
| Regular Cola | Experimental | Other: Nutritional Intervention |
| Diet cola | Experimental | Other: Nutritional Intervention |
| Orange juice | Experimental | Other: Nutritional Intervention |
| Water | Placebo comparator | Other: Nutritional Intervention |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy men and women
- age 20-30 years
- BMI between 20-24.9 kg/m^2
Key exclusion criteria (4 listed)
- breakfast skippers
- diabetes or any metabolic diseases
- lactose intolerance or allergies to milk
- taking medications
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 |
|---|---|---|
| Nutritional InterventionAd libitum amounts of beverage at a meal | Other | 1% Milk, Diet cola, Orange juice, Regular Cola, Water |
Primary outcome
Food Intake
Time frame: 2 hours
Measurement of energy intake during an ad libitum test meal
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 15 Jun 2012.
- Derived from this study: PubMed 25700893El Khoury D, Panahi S, Luhovyy BL, Douglas Goff H, Harvey Anderson G. Interaction of mealtime ad libitum beverage and food intake with meal advancement in healthy young men and women. Physiol Behav. 2015 May 1;143:39-44. doi: 10.1016/j.physbeh.2015.02.023. Epub 2015 Feb 18.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional Intervention in people with Obesity and Hyperglycemia, run by University of Toronto 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 3 inclusion and 4 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 15 Jun 2012. 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. Some participants in this study may receive a placebo. 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?
Food Intake (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01595919, which also lists 1 linked publication.
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 15 Jun 2012.