Dietary Protein Requirement of Elderly Men and Women | NCT00812500

Studies
Dietary Protein Requirement of Elderly Men and Women

NCT00812500

Sponsor

Purdue University

Status

Completed

Last Update Posted

Sep 24, 2013Estimated

Enrollment

48Actual

Phase

Not Applicable

Conditions

Interventions

Lower Protein
Medium Protein
Higher Protein

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2002

Primary Completion Date

May 2003Actual

Completion Date

Jan 2006Actual

First Submitted Date

Dec 18, 2008

First Submission Date that Met QC Criteria

Dec 19, 2008

First Posted Date

Dec 22, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 23, 2013

Last Update Posted Date

Sep 24, 2013Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Young men, age 21-46 years.	Other: Lower Protein Other: Medium Protein Other: Higher Protein
2	Experimental	Old Men, age 63-81 years.	Other: Lower Protein Other: Medium Protein Other: Higher Protein
3	Experimental	Young women, age 21-46 years.	Other: Lower Protein Other: Medium Protein Other: Higher Protein
4	Experimental	Old women, age 63-81 years.	Other: Lower Protein Other: Medium Protein Other: Higher Protein

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lower Protein	Other	Each subject completed an 18-day periods (trials) of strict dietary control of consuming a lower protein diet.	1 2 3

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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?		57 days

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Purdue University		West Lafayette	Indiana	47907	United States