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
  Purpose

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

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:


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):
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 April 17, 2014