Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Dietary Pork, Appetite and Weight Loss in Human

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wayne Campbell, Purdue University
ClinicalTrials.gov Identifier:
NCT01006343
First received: October 30, 2009
Last updated: September 23, 2013
Last verified: October 2009

October 30, 2009
September 23, 2013
Not Provided
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT01006343 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Dietary Pork, Appetite and Weight Loss in Human
Not Provided

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
  • Appetite
  • Weight Loss
  • Other: Higher Protein (HP)
  • Other: Lower Protein (LP)
  • 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.
    Intervention: 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.
    Intervention: Other: Lower Protein (LP)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
Not Provided
Not Provided

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.
Female
21 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01006343
0504001915
Not Provided
Wayne Campbell, Purdue University
Purdue University
Not Provided
Not Provided
Purdue University
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP