Dietary Protein Requirement of Elderly Men and Women

Age Clinical Trial

Official title:

Dietary Protein Requirement of Elderly Men and Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00812500
• Other study ID #: 00-226
• Status: Completed
• Phase: N/A
• First received: December 18, 2008
• Last updated: September 23, 2013
• Start date: May 2002
• Est. completion date: January 2006

Study information

• Verified date: December 2008
• Source: Purdue University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 2006
• Est. primary completion date: May 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Age

Intervention

Other:
• Lower Protein
Each subject completed an 18-day periods (trials) of strict dietary control of consuming a lower protein diet.
• Medium Protein
Each subject completed an 18-day periods (trials) of strict dietary control of consuming a medium protein diet.
• Higher Protein
Each subject completed an 18-day periods (trials) of strict dietary control of consuming a higher protein diet.

Locations

Country	Name	City	State
United States	Purdue University	West Lafayette	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Purdue University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the dietary protein requirement of older men and women.		57 days	Yes
Secondary	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	Yes