ObesityNCT00686192
Calcium and Lipid Metabolism
A study testing Calcium Carbonate in people with Obesity, run by USDA, Western Human Nutrition Research Center at 1 site in United States.
Trial summary
We hope to determine if supplementing the diet of women who habitually consume low levels of calcium, with 1500 mg of calcium a day for three months will increase fat oxidation and decrease fat storage. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Calcium Carbonate
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2001to Jul 2002
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI between 25 and 30 kg/m2
- Taking oral contraceptives
- Having regular menses
Who cannot join
- Pregnant
- History of metabolic bone, renal or thyroid disease,
- History of diabetes mellitus, or gestational diabetes mellitus
- Cigarette smoking
- Self-administration of calcium supplements
- Regular aerobic activity, i.e. jogging > 1 mile/day
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco General Hospital
San Francisco, California, 94110
About this study
Official title: The Effects of Calcium Supplementation on Adipocyte Metabolism in Overweight Women
We hope to determine if supplementing the diet of women who habitually consume low levels of calcium, with 1500 mg of calcium a day for three months will increase fat oxidation and decrease fat storage. We will also measure concentrations of lipids, glucose, hormones and enzymes associated with fat and carbohydrate metabolism to determine alterations and mechanism of the metabolic changes.
Read the detailed description
The incidence of obesity has rapidly increased in recent years and reached epidemic proportions in the United States. Recent epidemiological data has shown an inverse relationship between calcium intake and body fat and emerging research suggests that inadequate dietary calcium consumption may increase obesity. Studies in mice have shown that an increase in dietary calcium consumption creates a shift in the utilization of energy stores from carbohydrates to fat and a shift in the partitioning of energy from storage (as fat) to expenditure (as heat).
We will give 1500 mg of calcium a day for three months to women who habitually consume low levels of dietary calcium. The following measurements will be made before and after calcium supplementation: body fat by DEXA, lipolysis by infusion of stable isotopes of 1,1,2,3,3-[2H5] glycerol , hepatic glucose production by infusion of stable isotopes of 6,6-[2H2] glucose, lipogenesis by measurement of fatty acid synthase activity (14C radiochemical assay) , mRNA expression ( Real Time Polymerase Chain Reaction) and protein content (ELISA), indirect calorimetry measurement of non-protein respiratory quotient (NPRQ), energy expenditure, fat and carbohydrate oxidation. Serum calcium, glucose, cholesterol, triglycerides, LDL, HDL, parathyroid hormone, leptin, free fatty acids, adiponectin, 1,25(OH)2D, 25(OH)D and urinary calcium excretion will also be measured.
- Conditions
- Obesity
- Being tested
- Calcium Carbonate
- Keywords
- Obesity, Calcium carbonate, Dietary Supplements, Lipolysis
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium CarbonateDietary supplement
1500 mg per day
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipolysis by infusion of stable isotopes of 1,1,2,3,3-[2H5] glycerol
Measured: 0 and 3 months
Secondary outcomes (5)
Hepatic glucose production by infusion of stable isotopes of 6,6-[2H2] glucose
Measured: 0 and 3 months
Lipogenesis by measurement of fatty acid synthase activity (14C radiochemical assay) , mRNA expression ( Real Time Polymerase Chain Reaction) and protein content (ELISA)
Measured: 0 and 3 months
Indirect calorimetry measurement of non-protein respiratory quotient (NPRQ), energy expenditure, fat and carbohydrate oxidation
Measured: 0 and 3 months
Serum calcium, glucose, cholesterol, triglycerides, LDL, HDL, parathyroid hormone, leptin, free fatty acids, adiponectin, 1,25(OH)2D, 25(OH)D
Measured: 0 and 3 months
urinary calcium and sodium excretion
Measured: 0 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2008 (estimated)
- Study startSep 2001
- Primary completionJul 2002
- Study completionJul 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA, Western Human Nutrition Research Center
- Sponsor type
- US federal agency
- Collaborators
- University of California, Davis, San Francisco General Hospital
- Investigators
- Janet C King, PhD, Principal investigator, UCSF Benioff Children's Hospital Oakland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00686192
- Sponsor's protocol ID
- WHNRC001
- Status last verified
- May 2008
- First submitted
- 27 May 2008
- Last updated
- 22 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Calcium Supplementation on Adipocyte Metabolism in Overweight Women
- ClinicalTrials.gov ID
- NCT00686192
- Acronym / sponsor ID
- WHNRC001
- Conditions
- Obesity
- Keywords
- Obesity, Calcium carbonate, Dietary Supplements, Lipolysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- USDA, Western Human Nutrition Research CenterUS federal agency
- Collaborators
- University of California, Davis, San Francisco General Hospital
- Study start
- Sep 2001
- Primary completion
- Jul 2002 (actual)
- Study completion
- Jul 2002 (actual)
- First posted
- 29 May 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.
We hope to determine if supplementing the diet of women who habitually consume low levels of calcium, with 1500 mg of calcium a day for three months will increase fat oxidation and decrease fat storage. We will also measure concentrations of lipids, glucose, hormones and enzymes associated with fat and carbohydrate metabolism to determine alterations and mechanism of the metabolic changes.
Detailed description
The incidence of obesity has rapidly increased in recent years and reached epidemic proportions in the United States. Recent epidemiological data has shown an inverse relationship between calcium intake and body fat and emerging research suggests that inadequate dietary calcium consumption may increase obesity. Studies in mice have shown that an increase in dietary calcium consumption creates a shift in the utilization of energy stores from carbohydrates to fat and a shift in the partitioning of energy from storage (as fat) to expenditure (as heat).
We will give 1500 mg of calcium a day for three months to women who habitually consume low levels of dietary calcium. The following measurements will be made before and after calcium supplementation: body fat by DEXA, lipolysis by infusion of stable isotopes of 1,1,2,3,3-[2H5] glycerol , hepatic glucose production by infusion of stable isotopes of 6,6-[2H2] glucose, lipogenesis by measurement of fatty acid synthase activity (14C radiochemical assay) , mRNA expression ( Real Time Polymerase Chain Reaction) and protein content (ELISA), indirect calorimetry measurement of non-protein respiratory quotient (NPRQ), energy expenditure, fat and carbohydrate oxidation. Serum calcium, glucose, cholesterol, triglycerides, LDL, HDL, parathyroid hormone, leptin, free fatty acids, adiponectin, 1,25(OH)2D, 25(OH)D and urinary calcium excretion will also be measured.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI between 25 and 30 kg/m2
- Taking oral contraceptives
- Having regular menses
Key exclusion criteria (6 listed)
- Pregnant
- History of metabolic bone, renal or thyroid disease,
- History of diabetes mellitus, or gestational diabetes mellitus
- Cigarette smoking
- Self-administration of calcium supplements
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 |
|---|---|---|
| Calcium Carbonate1500 mg per day | Dietary supplement | – |
Primary outcome
Lipolysis by infusion of stable isotopes of 1,1,2,3,3-[2H5] glycerol
Time frame: 0 and 3 months
5 secondary outcomes
Hepatic glucose production by infusion of stable isotopes of 6,6-[2H2] glucose
Time frame: 0 and 3 months
Lipogenesis by measurement of fatty acid synthase activity (14C radiochemical assay) , mRNA expression ( Real Time Polymerase Chain Reaction) and protein content (ELISA)
Time frame: 0 and 3 months
Indirect calorimetry measurement of non-protein respiratory quotient (NPRQ), energy expenditure, fat and carbohydrate oxidation
Time frame: 0 and 3 months
Serum calcium, glucose, cholesterol, triglycerides, LDL, HDL, parathyroid hormone, leptin, free fatty acids, adiponectin, 1,25(OH)2D, 25(OH)D
Time frame: 0 and 3 months
urinary calcium and sodium excretion
Time frame: 0 and 3 months
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 22 Jul 2008.
- USDA Western Human Nutrition Research CenterLink 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.
Janet C King, PhD principal investigator
UCSF Benioff Children's Hospital Oakland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcium Carbonate in people with Obesity, run by USDA, Western Human Nutrition Research Center at 1 site in United States.
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 22 Jul 2008. 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 United States. 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?
Lipolysis by infusion of stable isotopes of 1,1,2,3,3-[2H5] glycerol (time frame: 0 and 3 months). 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 22 Jul 2008.