Glycemic ControlNCT01812967
Mechanism of Action of Milk and Its Components on Glycemic Control in Healthy Young Men
A study testing Milk Fat, Milk Protein and Lactose in people with Glycemic Control and Gastrointestinal Hormone Response, run by University of Toronto at 1 site in Canada.
Trial summary
The investigators hypothesize that the physiological effects of milk on satiety and glycemic control are mediated by the interaction between its macronutrient components by both insulin-dependent and independent mechanisms. 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
- Glycemic Control, Gastrointestinal Hormone Response, Healthy Young Men
- What is being tested?
- Milk Fat, Milk Protein and Lactose
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Start not givento Sep 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy young men
- 20-30 years of age
- BMI: 20-24.9 kg/m2
Who cannot join
- Smoking
- Dieting
- Skipping breakfast
- Lactose intolerance or allergies to milk
- Taking medications that may affect glucose metabolism or appetite
- Diabetes (fasting blood glucose ≥ 7.0 mmol/L) or other metabolic diseases
Trial locations and contacts
1 site in 1 country.
About this study
The investigators hypothesize that the physiological effects of milk on satiety and glycemic control are mediated by the interaction between its macronutrient components by both insulin-dependent and independent mechanisms.
- Being tested
- Milk Fat, Milk Protein, Lactose, Whole milk (3.25% M.F.(, Simulated Milk Beverage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milk FatDietary supplement
Milk ProteinDietary supplement
LactoseDietary supplement
Whole milk (3.25% M.F.(Other
Commercially available milk from the grocery store
Simulated Milk BeverageDietary supplement
Added lactose + fat + protein together to form a mixture
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose
Measured: 0-180 min
Secondary outcomes (1)
Insulin
Measured: 0-180 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2013 (estimated)
- Primary completionSep 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 Glycemic ControlStudies 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
- Crossover
- Enrolment
- 12 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
- NCT01812967
- Sponsor's protocol ID
- Milk Components Study
- Status last verified
- Mar 2013
- First submitted
- 13 Mar 2013
- Last updated
- 18 Mar 2013
- Results posted
- No
Publications
Panahi S, El Khoury D, Kubant R, Akhavan T, Luhovyy BL, Goff HD, Anderson GH. Mechanism of action of whole milk and its components on glycemic control in healthy young men. J Nutr Biochem. 2014 Nov;25(11):1124-1131. doi: 10.1016/j.jnutbio.2014.07.002. Epub 2014 Jul 31.
PubMed 25167977
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanism of Action of Milk and Its Components on Glycemic Control in Healthy Young Men
- ClinicalTrials.gov ID
- NCT01812967
- Acronym / sponsor ID
- Milk Components Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Primary completion
- Sep 2011 (actual)
- First posted
- 18 Mar 2013 (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 investigators hypothesize that the physiological effects of milk on satiety and glycemic control are mediated by the interaction between its macronutrient components by both insulin-dependent and independent mechanisms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy young men
- 20-30 years of age
- BMI: 20-24.9 kg/m2
Key exclusion criteria (6 listed)
- Smoking
- Dieting
- Skipping breakfast
- Lactose intolerance or allergies to milk
- Taking medications that may affect glucose metabolism or appetite
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 |
|---|---|---|
| Milk Fat | Dietary supplement | – |
| Milk Protein | Dietary supplement | – |
| Lactose | Dietary supplement | – |
| Whole milk (3.25% M.F.(Commercially available milk from the grocery store | Other | – |
| Simulated Milk BeverageAdded lactose + fat + protein together to form a mixture | Dietary supplement | – |
Primary outcome
Glucose
Time frame: 0-180 min
1 secondary outcome
Insulin
Time frame: 0-180 min
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 18 Mar 2013.
- Derived from this study: PubMed 25167977Panahi S, El Khoury D, Kubant R, Akhavan T, Luhovyy BL, Goff HD, Anderson GH. Mechanism of action of whole milk and its components on glycemic control in healthy young men. J Nutr Biochem. 2014 Nov;25(11):1124-1131. doi: 10.1016/j.jnutbio.2014.07.002. Epub 2014 Jul 31.
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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.
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 Milk Fat, Milk Protein and Lactose in people with Glycemic Control and Gastrointestinal Hormone Response, 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 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 18 Mar 2013. 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?
Glucose (time frame: 0-180 min). 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 NCT01812967, 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 18 Mar 2013.