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

Purpose

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

Condition	Intervention
Overweight	Dietary Supplement: Dietary calcium

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Effect of Dietary Calcium on Body Weight Regulation in Adults

Resource links provided by NLM:

MedlinePlus related topics: Calcium Weight Control

Drug Information available for: Calcium Gluconate

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Weight change [ Time Frame: 3 months of diet ] [ Designated as safety issue: No ]

Enrollment:	79
Study Start Date:	September 2004
Study Completion Date:	October 2007
Primary Completion Date:	September 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Dairy calcium Diet with dairy calcium sources	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.
Experimental: Non-dairy calcium Diet with non-dairy calcium sources	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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

18 -65 years old
Healthy

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00808275

Sponsors and Collaborators

Vanderbilt University

Investigators

Principal Investigator:

Maciej Buchowski, Ph.D.

Vanderbilt University

More Information

No publications provided by Vanderbilt University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Buchowski MS, Hongu N, Acra S, Wang L, Warolin J, Roberts LJ 2nd. Effect of modest caloric restriction on oxidative stress in women, a randomized trial. PLoS One. 2012;7(10):e47079. doi: 10.1371/journal.pone.0047079. Epub 2012 Oct 5.

Buchowski MS, Aslam M, Dossett C, Dorminy C, Choi L, Acra S. Effect of dairy and non-dairy calcium on fecal fat excretion in lactose digester and maldigester obese adults. Int J Obes (Lond). 2010 Jan;34(1):127-35. Epub 2009 Oct 13.

Responsible Party:	Maciej Buchowski, Research Professor, Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00808275 History of Changes
Other Study ID Numbers:	010590
Study First Received:	December 12, 2008
Last Updated:	December 2, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Vanderbilt University:

dietary calcium
weight loss

Additional relevant MeSH terms:

Body Weight
Overweight
Signs and Symptoms
Calcium, Dietary

Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013

To Top