Dietary Pork, Appetite and Weight Loss in Human
This study has been completed.
Sponsor:
Purdue University
Information provided by:
Purdue University
ClinicalTrials.gov Identifier:
NCT01006343
First received: October 30, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
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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 More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT01006343 History of Changes |
| Other Study ID Numbers: | 0504001915 |
| Study First Received: | October 30, 2009 |
| Last Updated: | October 30, 2009 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Weight Loss Body Weight Changes Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013