Protein-Sparing Modified Fast Intervention for Weight Loss in Obese Endometrial Cancer Survivors

Summary

This pilot clinical trial studies protein-sparing modified fast (PSMF) intervention for weight loss in obese endometrial cancer survivors. The PSMF is a diet that is very low in carbohydrates and calories, designed to induce fast, safe weight loss. The diet consists of only lean meats (beef, pork, poultry, and seafood) in amounts adequate to meet protein requirements based on the individual's body weight. The PSMF may help endometrial cancer survivors achieve significant weight loss, reduce the risk of chronic disease, and improve quality of life.

Conditions

• Endometrial Cancer
• Obesity

Interventions

DIETARY_SUPPLEMENT

Dietary Intervention

Follow the Protein-Sparing Modified Fast (PSMF) intervention. This diet has participants consume enough lean beef, pork, poultry, and seafood to provide 1.2 grams of protein per kilogram of their obesity adjusted ideal body weight.

OTHER

Informational Material

Receive carbohydrate reintroduction handout

OTHER

Dietary Education

Receive education on nutrition label reading for carbohydrates

DIETARY_SUPPLEMENT

Weight Maintenance

weight maintenance diet consists of gradual addition of previously eliminated carbohydrate containing food groups to the high protein PSMF diet. During weight maintenance, consumption of non-starchy vegetables is unlimited

OTHER

Average score of Obesity and Weight-Loss Quality of Life Questionnaire

Participants will take a tailored quality of life questionnaire. These scores will be averaged and a group mean reported. Higher scores indicate greater quality of life.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Case Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Kimberly Resnick · Case Comprehensive Cancer Center

Study Design

Allocation

NA

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-08-08

Primary Completion

2017-04-19

Completion

2017-04-19

Countries

• United States

Study Locations