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Dietary Protein Requirement of Elderly Men and Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00812500
First Posted: December 22, 2008
Last Update Posted: September 24, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Wayne Campbell, Purdue University
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Dietary Protein Requirement of Elderly Men and Women

Resource links provided by NLM:


Further study details as provided by Wayne Campbell, Purdue University:

Primary Outcome Measures:
  • To determine the dietary protein requirement of older men and women. [ Time Frame: 57 days ]

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 ]

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
Experimental: 1
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.
Experimental: 2
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.
Experimental: 3
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.
Experimental: 4
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00812500


Locations
United States, Indiana
Purdue University
West Lafayette, Indiana, United States, 47907
Sponsors and Collaborators
Purdue University
  More Information

Responsible Party: Wayne Campbell, Prof. Foods and Nutrition, Purdue University
ClinicalTrials.gov Identifier: NCT00812500     History of Changes
Other Study ID Numbers: 00-226
First Submitted: December 18, 2008
First Posted: December 22, 2008
Last Update Posted: September 24, 2013
Last Verified: December 2008

Keywords provided by Wayne Campbell, Purdue University:
assess the effect of age on the EAR and RDA for protein