Calcium and Lipid Metabolism
The Effects of Calcium Supplementation on Adipocyte Metabolism in Overweight Women
1 other identifier
interventional
15
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Sep 2001
Shorter than P25 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2002
CompletedFirst Submitted
Initial submission to the registry
May 27, 2008
CompletedFirst Posted
Study publicly available on registry
May 29, 2008
CompletedJuly 22, 2008
May 1, 2008
10 months
May 27, 2008
July 21, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Lipolysis by infusion of stable isotopes of 1,1,2,3,3-[2H5] glycerol
0 and 3 months
Secondary Outcomes (5)
Hepatic glucose production by infusion of stable isotopes of 6,6-[2H2] glucose
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)
0 and 3 months
Indirect calorimetry measurement of non-protein respiratory quotient (NPRQ), energy expenditure, fat and carbohydrate oxidation
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
0 and 3 months
urinary calcium and sodium excretion
0 and 3 months
Interventions
1500 mg per day
Eligibility Criteria
You may qualify if:
- BMI between 25 and 30 kg/m2
- Taking oral contraceptives
- Having regular menses
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- USDA, Western Human Nutrition Research Centerlead
- University of California, Daviscollaborator
- San Francisco General Hospitalcollaborator
Study Sites (1)
San Francisco General Hospital
San Francisco, California, 94110, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Janet C King, PhD
UCSF Benioff Children's Hospital Oakland
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
Study Record Dates
First Submitted
May 27, 2008
First Posted
May 29, 2008
Study Start
September 1, 2001
Primary Completion
July 1, 2002
Study Completion
July 1, 2002
Last Updated
July 22, 2008
Record last verified: 2008-05