The Body's Response to Changes in Dietary Protein and Mea... | NCT01171716

Studies
The Body's Response to Changes in Dietary Protein and Meal-Frequency In Men

NCT01171716

Sponsor

Purdue University

Status

Completed

Last Update Posted

Jan 17, 2013Estimated

Enrollment

13Actual

Phase

Not Applicable

Conditions

Low Protein Dietary Intake
High Protein Dietary Intake

Interventions

Meal Patterning

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

Jan 2013

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

Sep 2007

Primary Completion Date

Jul 2008Actual

Completion Date

Jul 2008Actual

First Submitted Date

Jul 27, 2010

First Submission Date that Met QC Criteria

Jul 27, 2010

First Posted Date

Jul 28, 2010Estimated

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

Jan 16, 2013

Last Update Posted Date

Jan 17, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

the purpose of this study is to identify how the body responds to increased dietary protein (that includes pork and eggs) and meal-frequency in adult men. During this study, the changes in blood glucose, hormones, appetite, and energy expenditure will be examined.

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

13Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dietary Protein Intake	Other	LP intake 3 meals and 6 meals HP intake 3 meals and 6 meals	Other: Meal Patterning

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Meal Patterning	Other	LP intake 3 meals and 6 meals HP intake 3 meals and 6 meals	Dietary Protein Intake

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Body's Response to Changes in Dietary Protein and Meal-Frequency In Men		12 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

21 and older, BMI between 25.0-34.6, Weight Stable for at least 6 mths, body >25%, non smoking, clinically normal blood profiles, non-diabetic.

Exclusion Criteria:

intermittently been involved in a diet and/or exercise program within the last 3 months, Have no allergies to eggs.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

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, Dept of Foods and Nutrition		West Lafayette	Indiana	47906	United States

Condition Browse Module

MeSH Terms

ID	Term
D050177	Overweight

Ancestor Terms

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight

Browse Leaves

Not provided

Browse Branches

Not provided