HealthyNCT01673321
Protein Concentrations in Yogurt and Satiety, Food Intake and Glycemia in Healthy Men
A study testing Dietary intervention in people with Healthy and Glucose Metabolism, run by University of Toronto at 1 site in Canada.
Trial summary
This study compared the effects of dairy products, including milk and yogurt, with different amounts of proteins on responses of appetite, glucose and insulin and on food intake at a meal served 120 minutes later in healthy adult male individuals. Read more about this study
- Who is it for?
- Ages 20 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Glucose Metabolism
- What is being tested?
- Dietary intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2012to Jun 2012
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 20-30 years
- Body mass index: 20 and 24.9 kg/m2
Who cannot join
- Breakfast skippers,
- Smokers,
- Dieters,
- Individuals with lactose-intolerance or who are allergic to milk,
- Individuals with gastrointestinal problems and
- Individuals with diabetes or other metabolic diseases
Trial locations and contacts
1 site in 1 country.
Canada1 site
Department of Nutritional Sciences, University of Toronto
Toronto, Ontario, M5S 3E2
About this study
Official title: Effect of Varied Protein Concentrations in Greek Yogurt on Glycemic Response, Satiety and Next Meal Food Intake in Healthy Young Men
This study compared the effects of dairy products, including milk and yogurt, with different amounts of proteins on responses of appetite, glucose and insulin and on food intake at a meal served 120 minutes later in healthy adult male individuals.
- Conditions
- Healthy, Glucose Metabolism
- Being tested
- Dietary intervention
- Keywords
- Yogurt, Milk, Protein, Food intake, Appetite, Glucose, Insulin
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary interventionOther
All snacks (arms) were randomly given to subjects to be consumed within 5 minutes, after 4 hours of consuming a standard breakfast.
| Study group | Role | What they receive |
|---|---|---|
| Non-fat Yogurt-Plain flavored | Experimental | Protein to carbohydrate ratio: 2.30 Receives: Other: Dietary intervention |
| Skim milk | Experimental | Protein to carbohydrate ratio: 0.69 Receives: Other: Dietary intervention |
| Non-fat Yogurt with honey-Plain flavored | Experimental | Protein to carbohydrate ratio: 1.24 Receives: Other: Dietary intervention |
| Orange juice | Experimental | Protein to carbohydrate ratio: 0.07 Receives: Other: Dietary intervention |
| Non-fat Yogurt-Strawberry flavored | Experimental | Protein to carbohydrate ratio: 0.79 Receives: Other: Dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food intake
Calories consumed at the test meal
Measured: 120 minutes after consumption of treatments
Secondary outcomes (1)
Glycemia
Glycemic responses in the pre- and post-test meal periods
Measured: Pre-(0-120 min) and post-(120-260 min) meal periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2012 (estimated)
- Study startFeb 2012
- Primary completionJun 2012
- Study completionJun 2012
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 HealthyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Natural Sciences and Engineering Research Council, Canada, Dairy Farmers of Ontario, Mondelēz International, Inc.
- Responsible party
- Principal investigator, G. Harvey Anderson, University of Toronto
- Investigators
- G. Harvey Anderson, Professor, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01673321
- Sponsor's protocol ID
- 27226
- Status last verified
- Aug 2012
- First submitted
- 22 Aug 2012
- Last updated
- 27 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
El Khoury D, Brown P, Smith G, Berengut S, Panahi S, Kubant R, Anderson GH. Increasing the protein to carbohydrate ratio in yogurts consumed as a snack reduces post-consumption glycemia independent of insulin. Clin Nutr. 2014 Feb;33(1):29-38. doi: 10.1016/j.clnu.2013.03.010. Epub 2013 Mar 27.
PubMed 23591152
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Varied Protein Concentrations in Greek Yogurt on Glycemic Response, Satiety and Next Meal Food Intake in Healthy Young Men
- ClinicalTrials.gov ID
- NCT01673321
- Acronym / sponsor ID
- 27226
- Conditions
- Healthy, Glucose Metabolism
- Keywords
- Yogurt, Milk, Protein, Food intake, Appetite, Glucose, Insulin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Natural Sciences and Engineering Research Council, Canada, Dairy Farmers of Ontario, Mondelēz International, Inc.
- Study start
- Feb 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 27 Aug 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.
This study compared the effects of dairy products, including milk and yogurt, with different amounts of proteins on responses of appetite, glucose and insulin and on food intake at a meal served 120 minutes later in healthy adult male individuals.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Non-fat Yogurt-Plain flavored | Experimental | Other: Dietary interventionProtein to carbohydrate ratio: 2.30 |
| Skim milk | Experimental | Other: Dietary interventionProtein to carbohydrate ratio: 0.69 |
| Non-fat Yogurt with honey-Plain flavored | Experimental | Other: Dietary interventionProtein to carbohydrate ratio: 1.24 |
| Orange juice | Experimental | Other: Dietary interventionProtein to carbohydrate ratio: 0.07 |
| Non-fat Yogurt-Strawberry flavored | Experimental | Other: Dietary interventionProtein to carbohydrate ratio: 0.79 |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age: 20-30 years
- Body mass index: 20 and 24.9 kg/m2
Key exclusion criteria (6 listed)
- Breakfast skippers,
- Smokers,
- Dieters,
- Individuals with lactose-intolerance or who are allergic to milk,
- Individuals with gastrointestinal problems and
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 |
|---|---|---|
| Dietary interventionAll snacks (arms) were randomly given to subjects to be consumed within 5 minutes, after 4 hours of consuming a standard breakfast. | Other | Non-fat Yogurt with honey-Plain flavored, Non-fat Yogurt-Plain flavored, Non-fat Yogurt-Strawberry flavored, Orange juice, Skim milk |
Primary outcome
Food intake
Time frame: 120 minutes after consumption of treatments
Calories consumed at the test meal
1 secondary outcome
Glycemia
Time frame: Pre-(0-120 min) and post-(120-260 min) meal periods
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 27 Aug 2012.
- Derived from this study: PubMed 23591152El Khoury D, Brown P, Smith G, Berengut S, Panahi S, Kubant R, Anderson GH. Increasing the protein to carbohydrate ratio in yogurts consumed as a snack reduces post-consumption glycemia independent of insulin. Clin Nutr. 2014 Feb;33(1):29-38. doi: 10.1016/j.clnu.2013.03.010. Epub 2013 Mar 27.
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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.
G. Harvey Anderson, Professor principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary intervention in people with Healthy and Glucose Metabolism, 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 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 27 Aug 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. 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: 120 minutes after consumption of treatments). 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 NCT01673321, 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 27 Aug 2012.