MedDataX Logo

Dietary Pork, Appetite and Weight Loss in Human

NCT ID: NCT01006343

Last Updated: 2013-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Appetite Weight Loss

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Higher Protein (HP)

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Lower Protein (LP)

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Higher Protein (HP)

Intervention Type OTHER

Lower Protein (LP)

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Purdue University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Wayne Campbell

Professor, Foods and Nutrition

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Purdue University

West Lafayette, Indiana, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0504001915

Identifier Type: -

Identifier Source: org_study_id