Calcium and Lipid Metabolism

July 21, 2008 updated by: USDA, Western Human Nutrition Research Center

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.

Study Overview

Status

Completed

Conditions

Obesity

Intervention / Treatment

Dietary supplement: Calcium Carbonate

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 Type

Interventional

Enrollment (Actual)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - San Francisco, California, United States, 94110
    - San Francisco General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Lipolysis by infusion of stable isotopes of 1,1,2,3,3-[2H5] glycerol Time Frame: 0 and 3 months	0 and 3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Hepatic glucose production by infusion of stable isotopes of 6,6-[2H2] glucose Time Frame: 0 and 3 months	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	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	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	0 and 3 months
urinary calcium and sodium excretion Time Frame: 0 and 3 months	0 and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

USDA, Western Human Nutrition Research Center

Collaborators

University of California, Davis

San Francisco General Hospital

Investigators

Principal Investigator: Janet C King, PhD, UCSF Benioff Children's Hospital Oakland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

USDA Western Human Nutrition Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2001

Primary Completion (Actual)

July 1, 2002

Study Completion (Actual)

July 1, 2002

Study Registration Dates

First Submitted

May 27, 2008

First Submitted That Met QC Criteria

May 28, 2008

First Posted (Estimate)

May 29, 2008

Study Record Updates

Last Update Posted (Estimate)

July 22, 2008

Last Update Submitted That Met QC Criteria

July 21, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

WHNRC001

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