Dietary Pork, Appetite and Weight Loss in Human

September 23, 2013 updated by: Wayne Campbell, Purdue University
The entire study protocol will last 13 weeks. Women will be randomly assigned to one of two experimental groups: high and low protein. All women will consume their unrestricted habitual diet during week 1 while baseline testing and measurements are taken. Starting at week 2, women in both groups will be counseled to consume a 750 kcal/day energy deficit diet containing either the RDA (LP group) or more than the recommended dietary allowance (RDA) (HP group) for protein. The energy restriction period will continue for 12 weeks (through study week 13) and is expected to result in body weight reduction of approximately 17 pounds. Testing and measurements will be repeated during week 13.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

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
      • West Lafayette, Indiana, United States, 47907
        • 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

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Eligible women will have a body mass index (BMI: weight (kg)/height (m2)) ranging from 26-36.
  • Must be at least 21 years old.

Exclusion Criteria:

  • Women with medical conditions that might place them at risk for participating in the study or interfere with the successful completion of the study protocol will be excluded.
  • BMI <26 or >36.
  • Younger than 21 years old.

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Higher Protein (HP)
Subjects will be required to follow their seven day menu plan for the 12 weeks of intervention. The HP menus will contain 30% protein, 45% carbohydrate, and 25% fat. Subjects in the HP group will be provided with portioned, cooked and frozen pork products as part of their HP menu plan.
Other: Higher Protein (HP)
Experimental: Lower Protein (LP)
Subjects will be required to follow their seven day menu plan for the 12 weeks of intervention. The LP group menus will contain 18% protein, 57% carbohydrate, 25% fat. The LP group will follow a lacto-ovo vegetarian menu with no striated tissue foods. Subjects in the LP group will be provided with selected, portioned dairy products.
Other: Lower Protein (LP)

Collaborators and Investigators

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

Sponsor

Purdue University

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 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)

September 24, 2013

Last Update Submitted That Met QC Criteria

September 23, 2013

Last Verified

October 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0504001915

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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