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
  Purpose

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.


Condition Intervention
Appetite
Weight Loss
Other: Higher Protein (HP)
Other: Lower Protein (LP)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Purdue University:

Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01006343

Locations
United States, Indiana
Purdue University
West Lafayette, Indiana, United States, 47907
Sponsors and Collaborators
Purdue University
  More Information

No publications provided

Responsible Party: Wayne Campbell, Professor, Foods and Nutrition, Purdue University
ClinicalTrials.gov Identifier: NCT01006343     History of Changes
Other Study ID Numbers: 0504001915
Study First Received: October 30, 2009
Last Updated: September 23, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Weight Loss
Body Weight
Body Weight Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on October 22, 2014