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Dietary Pork, Appetite and Weight Loss in Human

Primary Purpose

Appetite, Weight Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Higher Protein (HP)
Lower Protein (LP)
Sponsored by
Purdue University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Appetite

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Purdue University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Higher Protein (HP)

Lower Protein (LP)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 30, 2009
Last Updated
September 23, 2013
Sponsor
Purdue University
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1. Study Identification

Unique Protocol Identification Number
NCT01006343
Brief Title
Dietary Pork, Appetite and Weight Loss in Human
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Purdue University

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appetite, Weight Loss

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Allocation
Randomized

8. Arms, Groups, and Interventions

Arm Title
Higher Protein (HP)
Arm Type
Experimental
Arm Description
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.
Arm Title
Lower Protein (LP)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Higher Protein (HP)
Intervention Type
Other
Intervention Name(s)
Lower Protein (LP)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Purdue University
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47907
Country
United States

12. IPD Sharing Statement

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Dietary Pork, Appetite and Weight Loss in Human

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