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

Tracking Information

First Received Date ^ICMJE

May 27, 2008

Last Updated Date

July 21, 2008

Start Date ^ICMJE

September 2001

Primary Completion Date

July 2002 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00686192 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Calcium and Lipid Metabolism

Official Title ^ICMJE

The Effects of Calcium Supplementation on Adipocyte Metabolism in Overweight Women

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.

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 ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Obesity

Intervention ^ICMJE

Dietary Supplement: Calcium Carbonate

1500 mg per day

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2002

Primary Completion Date

July 2002 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

20 Years to 40 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00686192

Other Study ID Numbers ^ICMJE

WHNRC001

Has Data Monitoring Committee

Responsible Party

Janet C. King, PhD, Children's Hospital Oakland Research Institute

Study Sponsor ^ICMJE

USDA, Western Human Nutrition Research Center

Collaborators ^ICMJE

University of California, Davis
San Francisco General Hospital

Investigators ^ICMJE

Principal Investigator:

Janet C King, PhD

Children's Hospital & Research Center Oakland

Information Provided By

USDA, Western Human Nutrition Research Center

Verification Date

May 2008

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

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