NCT01171716

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 27, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 28, 2010

Completed
Last Updated

January 17, 2013

Status Verified

January 1, 2013

Enrollment Period

10 months

First QC Date

July 27, 2010

Last Update Submit

January 16, 2013

Conditions

Low Protein Dietary IntakeHigh Protein Dietary Intake

Keywords

overweight, protein intake, satiety, eating, meal patterns

Outcome Measures

Primary Outcomes (1)

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

    12 weeks

Study Arms (1)

Dietary Protein Intake

OTHER

LP intake 3 meals and 6 meals HP intake 3 meals and 6 meals

Other: Meal Patterning

Interventions

Meal PatterningOTHER

LP intake 3 meals and 6 meals HP intake 3 meals and 6 meals

Dietary Protein Intake

Eligibility Criteria

Age21 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue University, Dept of Foods and Nutrition

West Lafayette, Indiana, 47906, United States

Location

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Wayne Campbell, Ph. D

Study Record Dates

First Submitted

July 27, 2010

First Posted

July 28, 2010

Study Start

September 1, 2007

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

January 17, 2013

Record last verified: 2013-01

Locations

US(1)