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

Obesity Clinical Trial

Official title:

A Pilot Study of a Protein-Sparing Modified Fast for Weight Loss in Obese Endometrial Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02135562
• Other study ID #: CASE1814
• Secondary ID: NCI-2014-00832CA
• Status: Completed
• Phase: N/A
• First received: May 8, 2014
• Last updated: September 18, 2017
• Start date: August 8, 2014
• Est. completion date: April 19, 2017

Study information

• Verified date: September 2017
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: April 19, 2017
• Est. primary completion date: April 19, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms
• Obesity
• Weight Loss

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:
• Informational Material
Receive carbohydrate reintroduction handout
• 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.

Locations

Country	Name	City	State
United States	Cleveland Medical Center, University Hospitals, Seidman Cancer Center, Case Comprehensive Cancer Center	Cleveland	Ohio
United States	MetroHealth Medical Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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