NCT00808275

Brief Summary

The purpose of this study is to determine the role of

  1. 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. 2.caloric restriction on biomarkers of inflammation and oxidative stress

Trial Health

100
On Track

Trial Health Score

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

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2004

Typical duration for not_applicable

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, 2004

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 15, 2008

Completed
Last Updated

December 6, 2011

Status Verified

December 1, 2011

Enrollment Period

2 years

First QC Date

December 12, 2008

Last Update Submit

December 2, 2011

Conditions

Overweight

Keywords

dietary calciumweight loss

Outcome Measures

Primary Outcomes (1)

  • Fat in stool as a percentage of fat intake

    3 months of diet

Secondary Outcomes (1)

  • Weight change

    3 months of diet

Study Arms (2)

Dairy calcium

EXPERIMENTAL

Diet with dairy calcium sources

Dietary Supplement: Dietary calcium

Non-dairy calcium

EXPERIMENTAL

Diet with non-dairy calcium sources

Dietary Supplement: Dietary calcium

Interventions

Dietary calciumDIETARY_SUPPLEMENT

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.

Dairy calciumNon-dairy calcium

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • Healthy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 23071718DERIVED

  • 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. doi: 10.1038/ijo.2009.212. Epub 2009 Oct 13.

    PMID: 19823185DERIVED

MeSH Terms

Conditions

OverweightWeight Loss

Interventions

Calcium, Dietary

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

Calcium CompoundsInorganic Chemicals

Study Officials

  • Maciej Buchowski, Ph.D.

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Professor

Study Record Dates

First Submitted

December 12, 2008

First Posted

December 15, 2008

Study Start

September 1, 2004

Primary Completion

September 1, 2006

Study Completion

October 1, 2007

Last Updated

December 6, 2011

Record last verified: 2011-12