Calcium and Lipid Metabolism

This study has been completed.
Sponsor:
Collaborators:
University of California, Davis
San Francisco General Hospital
Information provided by:
USDA, Western Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT00686192
First received: May 27, 2008
Last updated: July 21, 2008
Last verified: May 2008

May 27, 2008
July 21, 2008
September 2001
July 2002   (final data collection date for primary outcome measure)
Lipolysis by infusion of stable isotopes of 1,1,2,3,3-[2H5] glycerol [ Time Frame: 0 and 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00686192 on ClinicalTrials.gov Archive Site
  • Hepatic glucose production by infusion of stable isotopes of 6,6-[2H2] glucose [ Time Frame: 0 and 3 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Indirect calorimetry measurement of non-protein respiratory quotient (NPRQ), energy expenditure, fat and carbohydrate oxidation [ Time Frame: 0 and 3 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • urinary calcium and sodium excretion [ Time Frame: 0 and 3 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Calcium and Lipid Metabolism
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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Obesity
Dietary Supplement: Calcium Carbonate
1500 mg per day
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
July 2002
July 2002   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • BMI between 25 and 30 kg/m2
  • Taking oral contraceptives
  • Having regular menses

Exclusion Criteria:

  • 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
Female
20 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00686192
WHNRC001
No
Janet C. King, PhD, Children's Hospital Oakland Research Institute
USDA, Western Human Nutrition Research Center
  • University of California, Davis
  • San Francisco General Hospital
Principal Investigator: Janet C King, PhD Children's Hospital & Research Center Oakland
USDA, Western Human Nutrition Research Center
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP