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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Endometrial Cancer
• Intervention / Treatment: 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

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: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • MetroHealth Medical Center
    • Cleveland, Ohio, United States, 44106-5065
      • Cleveland Medical Center, University Hospitals, Seidman Cancer Center, Case Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in levels of total cholesterol	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.	Baseline up to 6 months
Changes in levels of markers of inflammation (C-reactive protein)	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.	Up to 6 months
Changes in levels of glucose	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.	Up to 6 months
Number of drop-out participants	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.	Up to 6 months
Average percentage of positive urinary ketone tests as a marker of dietary adherence	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.	Up to 6 months
Number of Participant with reported side effects	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	Up to 6 months
Changes in quality-of-life as assessed by the Obesity and Weight Loss Quality-of-Life Questionnaire	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.	Baseline up to 6 months
Changes in levels of markers of inflammation (interleukin 6)	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.	Up to 6 months
Changes in levels of markers of inflammation (tumor necrosis factor - alpha)	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.	Up to 6 months
Changes in levels of markers of inflammation (leptin)	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.	Up to 6 months
Changes in levels of LDL-cholesterol	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.	Baseline up to 6 months
Changes in levels of HDL-cholesterol	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.	Baseline up to 6 months
Changes in levels of triglycerides	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.	Baseline up to 6 months

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Kimberly Resnick, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2014
• Primary Completion (Actual): April 19, 2017
• Study Completion (Actual): April 19, 2017

Study Registration Dates

• First Submitted: May 8, 2014
• First Submitted That Met QC Criteria: May 8, 2014
• First Posted (Estimate): May 12, 2014

Study Record Updates

• Last Update Posted (Actual): September 20, 2017
• Last Update Submitted That Met QC Criteria: September 18, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: obesity; endometrial cancer; diet; high protein; survivor; protein-sparing modified fast intervention; PSMF
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Body Weight; Body Weight Changes; Weight Loss; Endometrial Neoplasms
• Other Study ID Numbers: CASE1814; P30CA043703 (U.S. NIH Grant/Contract); NCI-2014-00832 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); CASE 1814 (Other Identifier: Case Comprehensive Cancer Center)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No