ObesityNCT00729170
Milk Supplementation and Energy Balance.
A study testing Supplementation of milk (35% more calcium) in people with Obesity and Osteoporosis, run by Laval University at 1 site in Canada.
Trial summary
The aim of the project is to determine if milk supplementation during a caloric restriction program facilitates the lost of weight, improves the appetite control and attenuates the decrease of bone mineral content in low-calcium consumer women. Read more about this study
- Who is it for?
- Ages 25 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Osteoporosis
- What is being tested?
- Supplementation of milk (35% more calcium)
- How many people
- 41 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2006to Feb 2009
- 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 25 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Low-calcium consumer (less than 800 mg daily)
- BMI between 27 to 42 kg/m2
- Sedentary
- Healthy
Who cannot join
- In menopause
- Medications that alter the project's objectives
- Smoker
- Dietary supplement consumer
- High alcohol or caffeine consumer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Milk Supplementation on Body Composition, Bone Density and Satiety in Women Following a Weight Loss Program.
The aim of the project is to determine if milk supplementation during a caloric restriction program facilitates the lost of weight, improves the appetite control and attenuates the decrease of bone mineral content in low-calcium consumer women.
Read the detailed description
Calcium deficiency is related to a higher risk of obesity. Some studies showed a lost of weight by elevating the calcium consumption to reach the recommended level. Milk supplementation could be a good alternative to reach this objective, but its impact on weight loss and on appetite sensations has not been verified. Furthermore, losing weight leads to some negative consequences like a decrease of bone mineral content. Considering the benefits of milk on bone health, a higher intake of this food product during weight loss could represent a healthy strategy.
- Conditions
- Obesity, Osteoporosis
- Being tested
- Supplementation of milk (35% more calcium)
- Keywords
- Milk, Calcium, Weight loss, Bone density, Appetite
- Medical subject headings
- Obesity, Osteoporosis, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplementation of milk (35% more calcium)Dietary supplement
The supplement provides 1000 mg of calcium and 250 kcal daily.
What is being measured
The primary outcome is the main question the study is designed to answer.
Body composition (body weight, fat mass, anthropometric measurements)
Measured: Baseline, month 1, and month 6
Secondary outcomes (2)
Bone density (DXA)
Measured: Baseline and month 6
Appetite sensations
Measured: Baseline, month 1, and month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2008 (estimated)
- Study startOct 2006
- Primary completionSep 2008
- Study completionFeb 2009
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 Laval UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Dairy Farmers of Canada, National Dairy Council
- Responsible party
- Principal investigator, Angelo Tremblay, Laval University
- Investigators
- Angelo Tremblay, Ph.D., Principal investigator, Laval UniversityDenis R Joanisse, Ph.D., Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00729170
- Sponsor's protocol ID
- 1_Tremblay
- Status last verified
- Jun 2012
- First submitted
- 5 Aug 2008
- Last updated
- 2 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gilbert JA, Joanisse DR, Chaput JP, Miegueu P, Cianflone K, Almeras N, Tremblay A. Milk supplementation facilitates appetite control in obese women during weight loss: a randomised, single-blind, placebo-controlled trial. Br J Nutr. 2011 Jan;105(1):133-43. doi: 10.1017/S0007114510003119.
PubMed 21205360
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Milk Supplementation on Body Composition, Bone Density and Satiety in Women Following a Weight Loss Program.
- ClinicalTrials.gov ID
- NCT00729170
- Acronym / sponsor ID
- 1_Tremblay
- Conditions
- Obesity, Osteoporosis
- Keywords
- Milk, Calcium, Weight loss, Bone density, Appetite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Dairy Farmers of Canada, National Dairy Council
- Study start
- Oct 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 7 Aug 2008 (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 aim of the project is to determine if milk supplementation during a caloric restriction program facilitates the lost of weight, improves the appetite control and attenuates the decrease of bone mineral content in low-calcium consumer women.
Detailed description
Calcium deficiency is related to a higher risk of obesity. Some studies showed a lost of weight by elevating the calcium consumption to reach the recommended level. Milk supplementation could be a good alternative to reach this objective, but its impact on weight loss and on appetite sensations has not been verified. Furthermore, losing weight leads to some negative consequences like a decrease of bone mineral content. Considering the benefits of milk on bone health, a higher intake of this food product during weight loss could represent a healthy strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Low-calcium consumer (less than 800 mg daily)
- BMI between 27 to 42 kg/m2
- Sedentary
- Healthy
Key exclusion criteria (5 listed)
- In menopause
- Medications that alter the project's objectives
- Smoker
- Dietary supplement consumer
- High alcohol or caffeine consumer
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 |
|---|---|---|
| Supplementation of milk (35% more calcium)The supplement provides 1000 mg of calcium and 250 kcal daily. | Dietary supplement | – |
Primary outcome
Body composition (body weight, fat mass, anthropometric measurements)
Time frame: Baseline, month 1, and month 6
2 secondary outcomes
Bone density (DXA)
Time frame: Baseline and month 6
Appetite sensations
Time frame: Baseline, month 1, and month 6
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 2 Jul 2012.
- Derived from this study: PubMed 21205360Gilbert JA, Joanisse DR, Chaput JP, Miegueu P, Cianflone K, Almeras N, Tremblay A. Milk supplementation facilitates appetite control in obese women during weight loss: a randomised, single-blind, placebo-controlled trial. Br J Nutr. 2011 Jan;105(1):133-43. doi: 10.1017/S0007114510003119.
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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.
Angelo Tremblay, Ph.D. principal investigator
Laval University
Denis R Joanisse, Ph.D. principal investigator
Laval 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 Supplementation of milk (35% more calcium) in people with Obesity and Osteoporosis, run by Laval 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 4 inclusion and 5 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 2 Jul 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?
Body composition (body weight, fat mass, anthropometric measurements) (time frame: Baseline, month 1, and month 6). 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 NCT00729170, 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 2 Jul 2012; AzTrials last refreshed its copy on 2 Nov 2026.