Caloric Restriction and Body Weight in Adults

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Maciej Buchowski, Vanderbilt University

ClinicalTrials.gov Identifier:

NCT00808275

First received: December 12, 2008

Last updated: December 2, 2011

Last verified: December 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

December 12, 2008

Last Updated Date

December 2, 2011

Start Date ^ICMJE

September 2004

Primary Completion Date

September 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Fat in stool as a percentage of fat intake [ Time Frame: 3 months of diet ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00808275 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Weight change [ Time Frame: 3 months of diet ] [ 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

Caloric Restriction and Body Weight in Adults

Official Title ^ICMJE

Effect of Dietary Calcium on Body Weight Regulation in Adults

Brief Summary

The purpose of this study is to determine the role of

dietary calcium in fecal fat loss and the association between lactose maldigestion, dietary calcium level and source, and weight loss induced by caloric restriction.
caloric restriction on biomarkers of inflammation and oxidative stress

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Overweight

Intervention ^ICMJE

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.

Study Arm (s)

Experimental: Dairy calcium
Diet with dairy calcium sources

Intervention: Dietary Supplement: Dietary calcium
Experimental: Non-dairy calcium
Diet with non-dairy calcium sources

Intervention: Dietary Supplement: Dietary calcium

Publications *

* 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

October 2007

Primary Completion Date

September 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

18 -65 years old
Healthy

Exclusion Criteria:

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00808275

Other Study ID Numbers ^ICMJE

010590

Has Data Monitoring Committee

Yes

Responsible Party

Maciej Buchowski, Vanderbilt University

Study Sponsor ^ICMJE

Vanderbilt University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Maciej Buchowski, Ph.D.

Vanderbilt University

Information Provided By

Vanderbilt University

Verification Date

December 2011

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

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