Dietary Supplements and Exercise in Aging Adults

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Wayne Campbell, Purdue University

ClinicalTrials.gov Identifier:

NCT00761553

First received: September 25, 2008

Last updated: January 16, 2013

Last verified: January 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	September 25, 2008
Last Updated Date	January 16, 2013
Start Date ^ICMJE	October 2005
Primary Completion Date	June 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 26, 2008)	Appetite questionnaire, urine collection, strength testing, body composition, resting metabolic rate, food records, breath sample, activity assessments, dietary supplements, nightly logs, and resistive exercise. [ Time Frame: 23 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00761553 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Dietary Supplements and Exercise in Aging Adults
Official Title ^ICMJE	Not Provided
Brief Summary	The purpose of this study is to determine the effects of food supplements and strength training on appetite, the amount of energy used, and body composition.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Condition ^ICMJE	Exercise
Intervention ^ICMJE	Other: Dietary supplements with exercise Resistive exercise along with consuming two dietary supplements every day during both 8 week intervention periods, for a total of 16 weeks. Dietary Supplement: Dietary supplement without exercise Consuming two dietary supplements every day during both 8 week intervention periods, for a total of 16 weeks.
Study Arm (s)	Experimental: 1 Solid dietary supplements with exercise Intervention: Other: Dietary supplements with exercise Experimental: 2 Solid dietary supplements without exercise Intervention: Dietary Supplement: Dietary supplement without exercise Experimental: 3 Liquid dietary supplements with exercise Intervention: Other: Dietary supplements with exercise Experimental: 4 Liquid supplements without exercise Intervention: Dietary Supplement: Dietary supplement without exercise
Publications *	Not Provided
* 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	49
Completion Date	June 2009
Primary Completion Date	June 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Adults age 55 and older Body mass index 20 to ≤35 kg/m2 Weight stable (<4kg change within the last 3 months) Constant habitual activity patterns (no deviation > 1x/wk of 30 min/session within last 3 months) Clinically normal blood and urine profiles as determined by our study physician Not taking medications known to influence appetite nor any anti-inflammatory steroid medications No hip replacements Exclusion Criteria: Adults with medical conditions that might place them at risk for participating in the study or interfere with the successful completion of the study protocol will be excluded
Gender	Both
Ages	55 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00761553
Other Study ID Numbers ^ICMJE	0509003026, NIH/NIA 5R01AG021911
Has Data Monitoring Committee	Not Provided
Responsible Party	Wayne Campbell, Purdue University
Study Sponsor ^ICMJE	Purdue University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Purdue University
Verification Date	January 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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