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NCT00808275 Clinical Trial

Caloric Restriction and Body Weight in Adults

Overweight Clinical Trial

Official title:
Effect of Dietary Calcium on Body Weight Regulation in Adults

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00808275
Other study ID # 010590
Secondary ID
Status Completed
Phase N/A
First received December 12, 2008
Last updated December 2, 2011
Start date September 2004
Est. completion date October 2007

Study information
Verified date December 2011
Source Vanderbilt University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the role of

1. dietary calcium in fecal fat loss and the association between lactose maldigestion, dietary calcium level and source, and weight loss induced by caloric restriction.

2. caloric restriction on biomarkers of inflammation and oxidative stress

Recruitment information / eligibility
Status Completed
Enrollment 79
Est. completion date October 2007
Est. primary completion date September 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- 18 -65 years old

- Healthy

Exclusion Criteria:

- Body weight more than 300 lbs (body composition measurement instrument limit) diabetes

- Heart disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Dietary calcium
Dairy and non-dairy calcium provided as a part of diet in the amounts of 500 mg/day and 1500 mg/day. Diet contained 70% of daily caloric requirements.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Vanderbilt University

Outcome
Type Measure Description Time frame Safety issue
Primary Fat in stool as a percentage of fat intake 3 months of diet No
Secondary Weight change 3 months of diet No
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