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Completed

NCT Number: NCT00686192

Calcium and Lipid Metabolism

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.

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

San Francisco General Hospital

San Francisco, California, 94110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Calcium Carbonate

Dietary Supplement

1500 mg per day

Primary outcomes

  1. Lipolysis by infusion of stable isotopes of 1,1,2,3,3-[2H5] glycerol

    Time frame: 0 and 3 months

Secondary outcomes

  1. Hepatic glucose production by infusion of stable isotopes of 6,6-[2H2] glucose

    Time frame: 0 and 3 months

  2. 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

  3. Indirect calorimetry measurement of non-protein respiratory quotient (NPRQ), energy expenditure, fat and carbohydrate oxidation

    Time frame: 0 and 3 months

  4. 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

  5. urinary calcium and sodium excretion

    Time frame: 0 and 3 months

Sponsors and collaborators

Lead sponsor

USDA, Western Human Nutrition Research Center

Fed

Collaborators

  • San Francisco General Hospital
  • University of California, Davis

Registry information

Official study title

The Effects of Calcium Supplementation on Adipocyte Metabolism in Overweight Women

Important dates

Study start
2001
Primary completion
2002
Study completion
2002
First posted
May 29, 2008
Registry last updated
Jul 22, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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