Dietary Protein Requirement of Elderly Men and Women - Full Text View

Sponsored by:	Purdue University
Information provided by:	Purdue University
ClinicalTrials.gov Identifier:	NCT00812500

Purpose

The purpose of this study was to assess the effect of age on the estimated average requirement and adequate allowance for dietary protein.

Condition	Intervention
Age	Other: Lower Protein Other: Medium Protein Other: Higher Protein

MedlinePlus related topics: Dietary Proteins

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment

Further study details as provided by Purdue University:

Primary Outcome Measures:

To determine the dietary protein requirement of older men and women. [ Time Frame: 57 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

What is the lowest amount of protein that a man or women should eat each day to help him or her stay healthy? [ Time Frame: 57 days ] [ Designated as safety issue: Yes ]

Enrollment:	48
Study Start Date:	May 2002
Study Completion Date:	January 2006
Primary Completion Date:	May 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Young men, age 21-46 years.	Other: Lower Protein Each subject completed an 18-day periods (trials) of strict dietary control of consuming a lower protein diet. Other: Medium Protein Each subject completed an 18-day periods (trials) of strict dietary control of consuming a medium protein diet. Other: Higher Protein Each subject completed an 18-day periods (trials) of strict dietary control of consuming a higher protein diet.
2: Experimental Old Men, age 63-81 years.	Other: Lower Protein Each subject completed an 18-day periods (trials) of strict dietary control of consuming a lower protein diet. Other: Medium Protein Each subject completed an 18-day periods (trials) of strict dietary control of consuming a medium protein diet. Other: Higher Protein Each subject completed an 18-day periods (trials) of strict dietary control of consuming a higher protein diet.
3: Experimental Young women, age 21-46 years.	Other: Lower Protein Each subject completed an 18-day periods (trials) of strict dietary control of consuming a lower protein diet. Other: Medium Protein Each subject completed an 18-day periods (trials) of strict dietary control of consuming a medium protein diet. Other: Higher Protein Each subject completed an 18-day periods (trials) of strict dietary control of consuming a higher protein diet.
4: Experimental Old women, age 63-81 years.	Other: Lower Protein Each subject completed an 18-day periods (trials) of strict dietary control of consuming a lower protein diet. Other: Medium Protein Each subject completed an 18-day periods (trials) of strict dietary control of consuming a medium protein diet. Other: Higher Protein Each subject completed an 18-day periods (trials) of strict dietary control of consuming a higher protein diet.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Age: 21-46 years, 63-81 years old
Not diagnosed with diabetes or metabolic syndrome
Clinically normal blood laboratory values

Exclusion Criteria:

Age: 21 years of younger, 47-62 years old, and 82 years and older
BMI: 20-29 kg/m
Weight stable: <2kg change within the last 3 months
Physical Activity: constant habitual pattern, no deviation >1x week of 30/minute sessions within the last 3 months

Clinically abnormal values:

Blood
Urine

Also, exclude any:

Using meds that would influence appetite
Using any anti-inflammatory steroid medications
Has a joint replacement
A medical condition that might place them at risk for participating in the study or interfere with successful completion of the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00812500

Locations

United States, Indiana
Purdue University
West Lafayette, Indiana, United States, 47907

Sponsors and Collaborators

Purdue University

More Information

Responsible Party:	Purdue University ( Wayne Campbell )
Study ID Numbers:	00-226
Study First Received:	December 18, 2008
Last Updated:	December 19, 2008
ClinicalTrials.gov Identifier:	NCT00812500
Health Authority:	United States: Institutional Review Board

Keywords provided by Purdue University:

assess the effect of age on the EAR and RDA for protein

ClinicalTrials.gov processed this record on January 13, 2009