Effects of Dietary Protein Intake From Beef/Pork and Soy/Legumes on Appetite, Mood, and Weight Loss

March 19, 2014 updated by: Wayne Campbell, Purdue University
The primary aims of this study are to assess the effects of habitual dietary protein intakes across the acceptable macronutrient distribution range with lean beef/pork or soy/legumes as the predominate sources of protein on indices of daily appetite and mood, and on postprandial appetite, mood, energy expenditure, and glycemic responses during energy-restricted weight loss in overweight adults.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • W Lafayette, Indiana, United States, 47907
        • Purdue University
      • West Lafayette, Indiana, United States, 47906
        • Purdue University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age range: 21 years and older
  • Body mass index between 27.0-36.9 kg/m2
  • Non-smoking (within the last 6 months)
  • Weight stable (< 3 kg (~7 lbs) weight gain or loss within last 3 months)
  • Energy need for weight maintenance 1950-2750 kcal/day
  • Not dietary restrained
  • Menstruating women not pregnant or lactating
  • Constant habitual activity patterns (within last 3 months)
  • No Acute Illness (or have chronic diseases known to influence protein or energy metabolism)
  • Non-diabetic
  • Clinically normal blood profiles (within 10% of clinical normalcy)
  • Non-hypertensive
  • Not taking medications known to influence appetite or metabolism
  • Willingness to eat study foods
  • Able to travel to testing facility

Exclusion Criteria:

  • Age: <21 years
  • Body mass index: outside of the 27.0-36.9 kg/m2 range
  • Smoker (currently or within the last 6 months)
  • Gained or lost > 3.0 kg (7 lbs) within the last 3 months
  • Energy need for weight maintenance < 1950 or > 2750 kcal/day
  • Dietary restrained (≥ 14 on Three Factor Eating Questionnaire)
  • Pregnant, lactating, or non-menstruating women
  • Clinically diagnosed as a diabetic, or with liver or kidney disease/dysfunction, or osteoporosis
  • Clinically abnormal blood profiles as identified by our study physician, Arthur Rosen, MD
  • Hypertensive
  • Taking medications (currently or within the last 3 months) known to influence appetite or metabolism
  • Allergies to eggs
  • Lactose intolerance
  • Unwillingness to eat study foods
  • Inability to travel to testing facility

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: Beef/Pork
Participants consuming diet with beef/pork as predominate sources of protein
Other: Beef/Pork
Participants consuming diet containing 10, 20 or 30% dietary protein with beef/pork as the predominate sources of protein
Experimental: Arm 2: Soy/Legumes
Participants consuming diet with soy/legumes as predominate sources of protein
Other: Soy/Legumes
Participants consuming diet containing 10, 20, or 30% dietary protein with soy/legumes as the predominate sources of protein.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Increasing protein intake from lean beef/pork or soy/legumes sources will result in progressively decreased daily composite hunger and desire to eat, and increased fullness. The responses will not be different between groups of subjects.
Time Frame: 14 weeks
14 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Increasing the protein content of a test will result in progressively more robust and sustained changes in postprandial appetite and energy expenditure and blunted glycemic response. The responses will not be different between the groups of participants.
Time Frame: 14 weeks
14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Purdue University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

October 30, 2009

First Submitted That Met QC Criteria

October 30, 2009

First Posted (Estimate)

November 1, 2009

Study Record Updates

Last Update Posted (Estimate)

March 20, 2014

Last Update Submitted That Met QC Criteria

March 19, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0905008129 (Other Identifier: IRB Purdue University)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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