NCT01006343

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 2, 2009

Completed
Last Updated

September 24, 2013

Status Verified

October 1, 2009

First QC Date

October 30, 2009

Last Update Submit

September 23, 2013

Conditions

AppetiteWeight Loss

Study Arms (2)

Higher Protein (HP)

EXPERIMENTAL

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)

Lower Protein (LP)

EXPERIMENTAL

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)

Interventions

Higher Protein (HP)OTHER
Higher Protein (HP)
Lower Protein (LP)OTHER
Lower Protein (LP)

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

Location

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Foods and Nutrition

Study Record Dates

First Submitted

October 30, 2009

First Posted

November 2, 2009

Last Updated

September 24, 2013

Record last verified: 2009-10

Locations

US(1)