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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
History of Changes
  Purpose

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.


Condition Intervention
Obesity
 Dietary Supplement: Calcium Carbonate

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Effects of Calcium Supplementation on Adipocyte Metabolism in Overweight Women

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by USDA, Western Human Nutrition Research Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 15
Study Start Date: September 2001
Study Completion Date: July 2002
Primary Completion Date: July 2002 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: Calcium Carbonate
    1500 mg per day
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.

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00686192

Locations
United States, California
San Francisco General Hospital
San Francisco, California, United States, 94110
Sponsors and Collaborators
USDA, Western Human Nutrition Research Center
University of California, Davis
San Francisco General Hospital
Investigators
Principal Investigator: Janet C King, PhD Children's Hospital & Research Center Oakland
  More Information

Additional Information:
USDA Western Human Nutrition Research Center  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Janet C. King, PhD, Children's Hospital Oakland Research Institute
ClinicalTrials.gov Identifier: NCT00686192     History of Changes
Other Study ID Numbers: WHNRC001
Study First Received: May 27, 2008
Last Updated: July 21, 2008
Health Authority: United States: Federal Government

Keywords provided by USDA, Western Human Nutrition Research Center:
Obesity
Calcium carbonate
Dietary Supplements
Lipolysis

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Calcium, Dietary
 Calcium Carbonate
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antacids
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013