Dietary Protein Requirement of Elderly Men and Women

September 23, 2013 updated by: Wayne Campbell, Purdue University
The purpose of this study was to assess the effect of age on the estimated average requirement and adequate allowance for dietary protein.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the dietary protein requirement of older men and women.
Time Frame: 57 days
57 days

Secondary Outcome Measures

Outcome Measure
Time Frame
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
57 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Purdue University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2002

Primary Completion (Actual)

May 1, 2003

Study Completion (Actual)

January 1, 2006

Study Registration Dates

First Submitted

December 18, 2008

First Submitted That Met QC Criteria

December 19, 2008

First Posted (Estimate)

December 22, 2008

Study Record Updates

Last Update Posted (Estimate)

September 24, 2013

Last Update Submitted That Met QC Criteria

September 23, 2013

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 00-226

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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