OverweightNCT00808275
Caloric Restriction and Body Weight in Adults
A study testing Dietary calcium in people with Overweight, run by Vanderbilt University.
Trial summary
The purpose of this study is to determine the role of 1. dietary calcium in fecal fat loss and the association between lactose maldigestion, dietary calcium level and source, and weight loss induced by caloric restriction. 2. caloric restriction on biomarkers of inflammation and oxidative stress Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- Dietary calcium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- No sites listed yet
- Study dates
- Sep 2004to Oct 2007
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 -65 years old
- Healthy
Who cannot join
- Body weight more than 300 lbs (body composition measurement instrument limit) diabetes
- Heart disease
About this study
Official title: Effect of Dietary Calcium on Body Weight Regulation in Adults
The purpose of this study is to determine the role of
- dietary calcium in fecal fat loss and the association between lactose maldigestion, dietary calcium level and source, and weight loss induced by caloric restriction.
- caloric restriction on biomarkers of inflammation and oxidative stress
- Conditions
- Overweight
- Being tested
- Dietary calcium
- Keywords
- dietary calcium, weight loss
- Medical subject headings
- Overweight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary calciumDietary supplement
Dairy and non-dairy calcium provided as a part of diet in the amounts of 500 mg/day and 1500 mg/day. Diet contained 70% of daily caloric requirements.
| Study group | Role | What they receive |
|---|---|---|
| Dairy calcium | Experimental | Diet with dairy calcium sources Receives: Dietary Supplement: Dietary calcium |
| Non-dairy calcium | Experimental | Diet with non-dairy calcium sources Receives: Dietary Supplement: Dietary calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat in stool as a percentage of fat intake
Measured: 3 months of diet
Secondary outcomes (1)
Weight change
Measured: 3 months of diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2008 (estimated)
- Study startSep 2004
- Primary completionSep 2006
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maciej Buchowski, Vanderbilt University
- Investigators
- Maciej Buchowski, Ph.D., Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00808275
- Sponsor's protocol ID
- 010590
- Status last verified
- Dec 2011
- First submitted
- 12 Dec 2008
- Last updated
- 6 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Buchowski MS, Hongu N, Acra S, Wang L, Warolin J, Roberts LJ 2nd. Effect of modest caloric restriction on oxidative stress in women, a randomized trial. PLoS One. 2012;7(10):e47079. doi: 10.1371/journal.pone.0047079. Epub 2012 Oct 5.
PubMed 23071718Buchowski MS, Aslam M, Dossett C, Dorminy C, Choi L, Acra S. Effect of dairy and non-dairy calcium on fecal fat excretion in lactose digester and maldigester obese adults. Int J Obes (Lond). 2010 Jan;34(1):127-35. doi: 10.1038/ijo.2009.212. Epub 2009 Oct 13.
PubMed 19823185
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dietary Calcium on Body Weight Regulation in Adults
- ClinicalTrials.gov ID
- NCT00808275
- Acronym / sponsor ID
- 010590
- Conditions
- Overweight
- Keywords
- dietary calcium, weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Sep 2004
- Primary completion
- Sep 2006 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 15 Dec 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 purpose of this study is to determine the role of
- dietary calcium in fecal fat loss and the association between lactose maldigestion, dietary calcium level and source, and weight loss induced by caloric restriction.
- caloric restriction on biomarkers of inflammation and oxidative stress
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dairy calcium | Experimental | Dietary Supplement: Dietary calciumDiet with dairy calcium sources |
| Non-dairy calcium | Experimental | Dietary Supplement: Dietary calciumDiet with non-dairy calcium sources |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 -65 years old
- Healthy
Key exclusion criteria (2 listed)
- Body weight more than 300 lbs (body composition measurement instrument limit) diabetes
- Heart disease
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 calciumDairy and non-dairy calcium provided as a part of diet in the amounts of 500 mg/day and 1500 mg/day. Diet contained 70% of daily caloric requirements. | Dietary supplement | Dairy calcium, Non-dairy calcium |
Primary outcome
Fat in stool as a percentage of fat intake
Time frame: 3 months of diet
1 secondary outcome
Weight change
Time frame: 3 months of diet
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 6 Dec 2011.
- Derived from this study: PubMed 23071718Buchowski MS, Hongu N, Acra S, Wang L, Warolin J, Roberts LJ 2nd. Effect of modest caloric restriction on oxidative stress in women, a randomized trial. PLoS One. 2012;7(10):e47079. doi: 10.1371/journal.pone.0047079. Epub 2012 Oct 5.
- Derived from this study: PubMed 19823185Buchowski MS, Aslam M, Dossett C, Dorminy C, Choi L, Acra S. Effect of dairy and non-dairy calcium on fecal fat excretion in lactose digester and maldigester obese adults. Int J Obes (Lond). 2010 Jan;34(1):127-35. doi: 10.1038/ijo.2009.212. Epub 2009 Oct 13.
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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.
Maciej Buchowski, Ph.D. principal investigator
Vanderbilt University
Questions about this trial
What is this clinical trial studying?
A study testing Dietary calcium in people with Overweight, run by Vanderbilt University.
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 2 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 6 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
Fat in stool as a percentage of fat intake (time frame: 3 months of diet). 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 NCT00808275, which also lists 2 linked publications.
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 6 Dec 2011.