Protein-Sparing Modified Fast Intervention for Weight Loss in Obese Endometrial Cancer Survivors
NCT ID: NCT02135562
Last Updated: 2017-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
11 participants
INTERVENTIONAL
2014-08-08
2017-04-19
Brief Summary
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Detailed Description
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I. Investigate whether the PSMF leads to significant weight loss in obese endometrial cancer survivors (ECS).
II. To assess whether the approach is feasible, whether participants will remain in the study for the duration of the intervention while adhering to the various components of the protocol. To assess feasibility, examine the following variables: drop-out rates; rates of adherence to diet and supplemental protocol; and rates of common side-effects.
III. Assess whether the PSMF improves biomarkers of disease risk in this population. To assess whether this objective has been met, assess the following variables: blood lipids (total cholesterol, low density lipid \[LDL\] cholesterol, high density lipid \[HDL\] cholesterol, and triglycerides); glucose; and markers of inflammation (C-reactive protein, interleukin-6, tumor necrosis factor \[TNF\]-alpha, and leptin).
IV. Assess whether the PSMF leads to improvement in quality of life related to weight loss.
OUTLINE:
PSMF: Participants are instructed by a registered dietitian (RD) to consume enough lean beef, pork, poultry, and seafood to provide 1.2 grams of protein per kilogram of their obesity adjusted ideal body weight. The protein recommendation will be communicated to participants in terms of grams per day. Participants are encouraged to adhere as closely as possible to the protein recommendation. Based on the protein recommendation, participants are advised to consume a given amount (in ounces) of beef, pork, poultry and seafood daily, assuming that each ounce of these products contains seven grams of protein. Participants are provided with a digital kitchen scale to weigh protein-containing foods and are permitted up to 2 servings of non-starchy vegetables per day. Participants remain on the PSMF until they have successfully reduced their initial body weight by 15% or up to 6 months. Participants are also provided with supplements to consume daily.
WEIGHT MAINTENANCE DIET: After successful weight loss of at least 15% of initial body weight, participants are instructed by a RD to consume a weight maintenance diet or they may remain on the PSMF. The weight maintenance diet consists of gradual addition of previously eliminated carbohydrate containing food groups to the PSMF and consumption of non-starchy vegetables is unlimited. Participants receive handouts that list common foods and the number of carbohydrates in each serving and educated on nutrition label reading for carbohydrates, with emphasis on serving size and total number of carbohydrates per serving.
After completion of study, participants are followed up at 2 and 4 weeks and then at 2, 3, 4, 5, and 6 months.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Supportive Care (PSMF)
Participants will take part in a Protein-Sparing Modified Fast (PSMF) Intervention for weight loss. Participants will undergo a dietary intervention high in protein for 6 weeks or until they have loss 15% of their body weight. This intervention will be followed by weight maintenance in which participants reintroduce non-starchy vegetables to their diet. At this time participants will also receive informational material and dietary education which teaches participants how to read nutrition labels and calculate carbohydrate loads in foods. Participants are given the Obesity and Weight-Loss Quality of Life Questionnaire to survey the impact of the intervention
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.
Informational Material
Receive carbohydrate reintroduction handout
Dietary Education
Receive education on nutrition label reading for carbohydrates
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
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.
Interventions
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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.
Informational Material
Receive carbohydrate reintroduction handout
Dietary Education
Receive education on nutrition label reading for carbohydrates
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
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) \> 30 kg/m\^2
* \> 8 weeks removed from surgery to treat endometrial cancer
Exclusion Criteria
* BMI \< 30 kg/m\^2
* Any history of cardiovascular, kidney, or liver disease
* Using medication to treat diabetes
* History of cardiac arrhythmias
* Inability to comply with follow up regimen
* Inability to read or speak English
* Abstention from meat and other animal products
18 Years
70 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Case Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Kimberly Resnick
Role: PRINCIPAL_INVESTIGATOR
Case Comprehensive Cancer Center
Locations
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Cleveland Medical Center, University Hospitals, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Countries
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Other Identifiers
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NCI-2014-00832
Identifier Type: REGISTRY
Identifier Source: secondary_id
CASE1814
Identifier Type: -
Identifier Source: secondary_id
CASE 1814
Identifier Type: OTHER
Identifier Source: secondary_id
CASE1814
Identifier Type: -
Identifier Source: org_study_id