Dietary Protein Requirement of Elderly Men and Women
1 other identifier
interventional
48
1 country
1
Brief Summary
The purpose of this study was to assess the effect of age on the estimated average requirement and adequate allowance for dietary protein.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2002
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 18, 2008
CompletedFirst Posted
Study publicly available on registry
December 22, 2008
CompletedSeptember 24, 2013
December 1, 2008
1 year
December 18, 2008
September 23, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine the dietary protein requirement of older men and women.
57 days
Secondary Outcomes (1)
What is the lowest amount of protein that a man or women should eat each day to help him or her stay healthy?
57 days
Study Arms (4)
1
EXPERIMENTALYoung men, age 21-46 years.
2
EXPERIMENTALOld Men, age 63-81 years.
3
EXPERIMENTALYoung women, age 21-46 years.
4
EXPERIMENTALOld women, age 63-81 years.
Interventions
Each subject completed an 18-day periods (trials) of strict dietary control of consuming a lower protein diet.
Each subject completed an 18-day periods (trials) of strict dietary control of consuming a medium protein diet.
Each subject completed an 18-day periods (trials) of strict dietary control of consuming a higher protein diet.
Eligibility Criteria
You may qualify if:
- Age: 21-46 years, 63-81 years old
- Not diagnosed with diabetes or metabolic syndrome
- Clinically normal blood laboratory values
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Purdue University
West Lafayette, Indiana, 47907, United States
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Foods and Nutrition
Study Record Dates
First Submitted
December 18, 2008
First Posted
December 22, 2008
Study Start
May 1, 2002
Primary Completion
May 1, 2003
Study Completion
January 1, 2006
Last Updated
September 24, 2013
Record last verified: 2008-12