NCT00686192

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Sep 2001

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2002

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 29, 2008

Completed
Last Updated

July 22, 2008

Status Verified

May 1, 2008

Enrollment Period

10 months

First QC Date

May 27, 2008

Last Update Submit

July 21, 2008

Conditions

Keywords

ObesityCalcium carbonateDietary SupplementsLipolysis

Outcome Measures

Primary Outcomes (1)

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

    0 and 3 months

Secondary Outcomes (5)

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

    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)

    0 and 3 months

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

    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

    0 and 3 months

  • urinary calcium and sodium excretion

    0 and 3 months

Interventions

Calcium CarbonateDIETARY_SUPPLEMENT

1500 mg per day

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Francisco General Hospital

San Francisco, California, 94110, United States

Location

Related Links

MeSH Terms

Conditions

Obesity

Interventions

Calcium Carbonate

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Calcium CompoundsInorganic ChemicalsCarbonatesCarbonic AcidCarbon Compounds, InorganicMinerals

Study Officials

  • Janet C King, PhD

    UCSF Benioff Children's Hospital Oakland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

May 27, 2008

First Posted

May 29, 2008

Study Start

September 1, 2001

Primary Completion

July 1, 2002

Study Completion

July 1, 2002

Last Updated

July 22, 2008

Record last verified: 2008-05

Locations