Protein-Sparing Modified Fast Intervention for Weight Loss in Obese Endometrial Cancer Survivors
A Pilot Study of a Protein-Sparing Modified Fast for Weight Loss in Obese Endometrial Cancer Survivors
4 other identifiers
interventional
11
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2014
Typical duration for not_applicable
2 active sites
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
May 8, 2014
CompletedFirst Posted
Study publicly available on registry
May 12, 2014
CompletedStudy Start
First participant enrolled
August 8, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 19, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 19, 2017
CompletedSeptember 20, 2017
September 1, 2017
2.7 years
May 8, 2014
September 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Mean Weight loss assessed with the digital scale
Mean weight loss will be presented as mean total weight loss in kilograms from baseline
Baseline up to 6 months
Mean Weight loss assessed with the digital scale
Mean Weight loss will be presented as mean total weight loss in kilograms from baseline.
Baseline up to 12 months
Secondary Outcomes (13)
Changes in levels of total cholesterol
Baseline up to 6 months
Changes in levels of markers of inflammation (C-reactive protein)
Up to 6 months
Changes in levels of glucose
Up to 6 months
Number of drop-out participants
Up to 6 months
Average percentage of positive urinary ketone tests as a marker of dietary adherence
Up to 6 months
- +8 more secondary outcomes
Study Arms (1)
Supportive Care (PSMF)
EXPERIMENTALParticipants 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
Interventions
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.
Receive education on nutrition label reading for carbohydrates
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
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.
Eligibility Criteria
You may qualify if:
- Previous diagnosis of endometrial cancer, successfully treated through surgery
- Body mass index (BMI) \> 30 kg/m\^2
- \> 8 weeks removed from surgery to treat endometrial cancer
You may not qualify if:
- No previous diagnosis of endometrial cancer
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Case Comprehensive Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (2)
Cleveland Medical Center, University Hospitals, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kimberly Resnick
Case Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2014
First Posted
May 12, 2014
Study Start
August 8, 2014
Primary Completion
April 19, 2017
Study Completion
April 19, 2017
Last Updated
September 20, 2017
Record last verified: 2017-09