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

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ClinicalTrials.gov Identifier: NCT02135562
Recruitment Status : Completed
First Posted : May 12, 2014
Last Update Posted : September 20, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Tracking Information
First Submitted Date  ICMJE May 8, 2014
First Posted Date  ICMJE May 12, 2014
Last Update Posted Date September 20, 2017
Actual Study Start Date  ICMJE August 8, 2014
Actual Primary Completion Date April 19, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2014)
  • Mean Weight loss assessed with the digital scale [ Time Frame: Baseline up to 6 months ]
    Mean weight loss will be presented as mean total weight loss in kilograms from baseline
  • Mean Weight loss assessed with the digital scale [ Time Frame: Baseline up to 12 months ]
    Mean Weight loss will be presented as mean total weight loss in kilograms from baseline.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2014)
  • Changes in levels of total cholesterol [ Time Frame: Baseline up to 6 months ]
    Average differences in total cholesterol between time points will be assessed using a one-sided anova test with statistical significance defined as having a p-value < 0.05.
  • Changes in levels of markers of inflammation (C-reactive protein) [ Time Frame: Up to 6 months ]
    Average differences in C-reactive protein between time points will be assessed using a one-sided anova test with statistical significance defined as having a p-value < 0.05.
  • Changes in levels of glucose [ Time Frame: Up to 6 months ]
    Differences in glucose levels between time points will be assessed using a one-sided anova test with statistical significance defined as having a p-value < 0.05.
  • Number of drop-out participants [ Time Frame: Up to 6 months ]
    Presented as the difference in the number of participants who completed the study from the number of participants enrolled at baseline. This is reported as one of the markers of feasibility.
  • Average percentage of positive urinary ketone tests as a marker of dietary adherence [ Time Frame: Up to 6 months ]
    Assessed using the presence of urinary ketones beginning on day four of the intervention. Adherence rates will be presented as the percentage of positive urinary ketone tests for the duration of the intervention.
  • Number of Participant with reported side effects [ Time Frame: Up to 6 months ]
    Adverse events will be recorded by participants on a daily basis. Number of participants with related adverse events will be reported as one of the measures of feasibility
  • Changes in quality-of-life as assessed by the Obesity and Weight Loss Quality-of-Life Questionnaire [ Time Frame: Baseline up to 6 months ]
    The difference between mean quality of life scores at the two time points will be assessed using a one-sided anova test with statistical significance set at p < 0.05.
  • Changes in levels of markers of inflammation (interleukin 6) [ Time Frame: Up to 6 months ]
    Average differences in interleukin 6 between time points will be assessed using a one-sided anova test with statistical significance defined as having a p-value < 0.05.
  • Changes in levels of markers of inflammation (tumor necrosis factor - alpha) [ Time Frame: Up to 6 months ]
    Average differences in tumor necrosis factor - alpha between time points will be assessed using a one-sided anova test with statistical significance defined as having a p-value < 0.05.
  • Changes in levels of markers of inflammation (leptin) [ Time Frame: Up to 6 months ]
    Average differences of leptin between time points will be assessed using a one-sided anova test with statistical significance defined as having a p-value < 0.05.
  • Changes in levels of LDL-cholesterol [ Time Frame: Baseline up to 6 months ]
    Average differences between time points for LDL-cholesterol will be assessed using a one-sided anova test with statistical significance defined as having a p-value < 0.05.
  • Changes in levels of HDL-cholesterol [ Time Frame: Baseline up to 6 months ]
    Average differences between time points for HDL-cholesterol will be assessed using a one-sided anova test with statistical significance defined as having a p-value < 0.05.
  • Changes in levels of triglycerides [ Time Frame: Baseline up to 6 months ]
    Average differences between time points for triglycerides will be assessed using a one-sided anova test with statistical significance defined as having a p-value < 0.05.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Protein-Sparing Modified Fast Intervention for Weight Loss in Obese Endometrial Cancer Survivors
Official Title  ICMJE A Pilot Study of a Protein-Sparing Modified Fast for Weight Loss in Obese Endometrial Cancer Survivors
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.
Detailed Description

PRIMARY OBJECTIVES:

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Endometrial Cancer
  • Obesity
Intervention  ICMJE
  • 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 Names:
    • Dietary Modification
    • intervention, dietary
  • Other: Informational Material
    Receive carbohydrate reintroduction handout
  • Other: Dietary Education
    Receive education on nutrition label reading for carbohydrates
    Other Name: intervention, educational
  • 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.
Study Arms  ICMJE Experimental: 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
Interventions:
  • Dietary Supplement: Dietary Intervention
  • Other: Informational Material
  • Other: Dietary Education
  • Dietary Supplement: Weight Maintenance
  • Other: Average score of Obesity and Weight-Loss Quality of Life Questionnaire
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 9, 2016)
11
Original Estimated Enrollment  ICMJE
 (submitted: May 8, 2014)
20
Actual Study Completion Date  ICMJE April 19, 2017
Actual Primary Completion Date April 19, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02135562
Other Study ID Numbers  ICMJE CASE1814
NCI-2014-00832 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CASE1814
CASE 1814 ( Other Identifier: Case Comprehensive Cancer Center )
P30CA043703 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Case Comprehensive Cancer Center
Study Sponsor  ICMJE Case Comprehensive Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Kimberly Resnick Case Comprehensive Cancer Center
PRS Account Case Comprehensive Cancer Center
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP