OverweightNCT01553370
Randomized Controlled Trial of Milk Products and Physical Activity on Body Composition and Health in Overweight Young Males
A study testing Increased Dairy Intake and Supplemental carbohydrate in people with Overweight, run by Brock University at 1 site in Canada.
Trial summary
Maintaining a healthy body weight is a major challenge for the majority of Canadians. A lifestyle strategy that promotes maintenance of a healthy body weight and, perhaps most importantly, can be incorporated into daily life with relative ease is essential. Read more about this study
- Who is it for?
- Ages 18 to 28 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- Increased Dairy Intake and Supplemental carbohydrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2012to Feb 2013
- 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 28 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI greater or equal to 25
- healthy
Who cannot join
- any chronic cardiovascular condition or metabolic condition
- kidney disease
- gastro-intestinal disease
- milk or dairy protein allergies
- lactose intolerance
- chronic lung conditions
Show all 9Show fewer
- any condition that could potentially prevent participant from performing exercise
- allergy to local anaesthetics
- cumulative x-ray exposure and cumulative muscle biopsies
Trial locations and contacts
1 site in 1 country.
Canada1 site
Brock University
St. Catharines, Ontario, L2S 3A1
Brian D Roy, PhD, 905-688-5550 ext. 3779, broy@brocku.ca
Brian D Roy, PhD
About this study
Maintaining a healthy body weight is a major challenge for the majority of Canadians. A lifestyle strategy that promotes maintenance of a healthy body weight and, perhaps most importantly, can be incorporated into daily life with relative ease is essential. This study will determine if an effective strategy includes increased physical activity in conjunction with higher intakes of dairy products immediately following exercise. Fifty-six overweight adult males who do not regularly exercise will be assigned to one of four groups for 12 weeks. All groups will preform 12 weeks of exercise training (1 hour of cycling per day, 5 times per week). Two groups will consume supplemental low fat milk (3 servings per day) with one these groups consuming it immediately after exercise while the other will consume it either well before or long after the exercise session. The other two groups will consume a carbohydrate drink that has the same amount of energy as the low fat milk, with one of these groups consuming the drink right after exercise and the other another group will consume it either well before or long after the exercise session. Markers of health status including body weight, muscle mass, and bone mass will be measured at the start and after the 12- week intervention. The investigators anticipate that providing the low fat milk immediately after exercise will result in the most favorable changes in health outcomes, and provide a realistic lifestyle intervention for overweight individuals to attain a healthy body weight, and by doing so, optimize their ability to prevent chronic disease.
- Conditions
- Overweight
- Being tested
- Increased Dairy Intake, Supplemental carbohydrate
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Increased Dairy IntakeOther
3 additional servings of low fat dairy will be consumed
Supplemental carbohydrateOther
Maltodextrin will be provided in an amount equal to the the energy content in the 3 supplemental servings of low-fat dairy.
| Study group | Role | What they receive |
|---|---|---|
| Alternate Intake-time | Active comparator | Not described Receives: Other: Increased Dairy Intake; Other: Supplemental carbohydrate |
| Immediately post-exercise | Experimental | Not described Receives: Other: Increased Dairy Intake; Other: Supplemental carbohydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body composition
Measured: 12 weeks
Bone mineral density
Measured: 12 weeks
VO2 peak
Measured: 12 weeks
Secondary outcomes (6)
mitochondrial enzyme activity
Measured: 12 weeks
muscle oxidative stress
Measured: 12 weeks
muscle capillary density
Measured: 12 weeks
blood lipids
Measured: 12 weeks
blood inflammatory markers
Measured: 12 weeks
blood markers of bone turnover
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2012 (estimated)
- Study completionFeb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brock University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Roy, Brock University
- Investigators
- Brian D Roy, PhD, Principal investigator, Brock University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01553370
- Sponsor's protocol ID
- BUCT-11-221
- Status last verified
- Mar 2012
- First submitted
- 12 Mar 2012
- Last updated
- 14 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Milk Products and Physical Activity on Body Composition and Health in Overweight Young Males
- ClinicalTrials.gov ID
- NCT01553370
- Acronym / sponsor ID
- BUCT-11-221
- Conditions
- Overweight
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Brock UniversityUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Feb 2013 (estimated)
- First posted
- 14 Mar 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.
Maintaining a healthy body weight is a major challenge for the majority of Canadians. A lifestyle strategy that promotes maintenance of a healthy body weight and, perhaps most importantly, can be incorporated into daily life with relative ease is essential. This study will determine if an effective strategy includes increased physical activity in conjunction with higher intakes of dairy products immediately following exercise. Fifty-six overweight adult males who do not regularly exercise will be assigned to one of four groups for 12 weeks. All groups will preform 12 weeks of exercise training (1 hour of cycling per day, 5 times per week). Two groups will consume supplemental low fat milk (3 servings per day) with one these groups consuming it immediately after exercise while the other will consume it either well before or long after the exercise session. The other two groups will consume a carbohydrate drink that has the same amount of energy as the low fat milk, with one of these groups consuming the drink right after exercise and the other another group will consume it either well before or long after the exercise session. Markers of health status including body weight, muscle mass, and bone mass will be measured at the start and after the 12- week intervention. The investigators anticipate that providing the low fat milk immediately after exercise will result in the most favorable changes in health outcomes, and provide a realistic lifestyle intervention for overweight individuals to attain a healthy body weight, and by doing so, optimize their ability to prevent chronic disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alternate Intake-time | Active comparator | Other: Increased Dairy Intake, Other: Supplemental carbohydrate |
| Immediately post-exercise | Experimental | Other: Increased Dairy Intake, Other: Supplemental carbohydrate |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI greater or equal to 25
- healthy
Key exclusion criteria (9 listed)
- any chronic cardiovascular condition or metabolic condition
- kidney disease
- gastro-intestinal disease
- milk or dairy protein allergies
- lactose intolerance
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 |
|---|---|---|
| Increased Dairy Intake3 additional servings of low fat dairy will be consumed | Other | Alternate Intake-time, Immediately post-exercise |
| Supplemental carbohydrateMaltodextrin will be provided in an amount equal to the the energy content in the 3 supplemental servings of low-fat dairy. | Other | Alternate Intake-time, Immediately post-exercise |
Primary outcome
Body composition
Time frame: 12 weeks
Bone mineral density
Time frame: 12 weeks
VO2 peak
Time frame: 12 weeks
6 secondary outcomes
mitochondrial enzyme activity
Time frame: 12 weeks
muscle oxidative stress
Time frame: 12 weeks
muscle capillary density
Time frame: 12 weeks
blood lipids
Time frame: 12 weeks
blood inflammatory markers
Time frame: 12 weeks
blood markers of bone turnover
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2012.
- University websiteLink provided by the sponsor.
- Sponsor of the trialLink provided by the sponsor.
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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.
Brian D Roy, PhD principal investigator
Brock 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 Increased Dairy Intake and Supplemental carbohydrate in people with Overweight, run by Brock 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 9 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: status not confirmed, as of the sponsor's last update on 14 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brian D Roy, PhD (905-688-5550 ext. 3779, broy@brocku.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body composition (time frame: 12 weeks). 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 14 Mar 2012.