Dietary Protein Requirement of Elderly Men and Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wayne Campbell, Purdue University
ClinicalTrials.gov Identifier:
NCT00812500
First received: December 18, 2008
Last updated: September 23, 2013
Last verified: December 2008
  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: 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 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
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Wayne Campbell, Prof. Foods and Nutrition, Purdue University
ClinicalTrials.gov Identifier: NCT00812500     History of Changes
Other Study ID Numbers: 00-226
Study First Received: December 18, 2008
Last Updated: September 23, 2013
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 August 18, 2014