A Pilot Study of a Protein-Sparing Modified Fast for Weight Loss in Obese Endometrial Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 4
- 主要终点
- Mean Weight loss assessed with the digital scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Dietary Intervention (Dietary Supplement)
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
干预措施: Informational Material (Other)
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
干预措施: Dietary Education (Other)
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
干预措施: Weight Maintenance (Dietary Supplement)
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
干预措施: Average score of Obesity and Weight-Loss Quality of Life Questionnaire (Other)
结局指标
主要结局
Mean Weight loss assessed with the digital scale
时间窗: Baseline up to 12 months
Mean Weight loss will be presented as mean total weight loss in kilograms from baseline.
次要结局
- Changes in levels of glucose(Up to 6 months)
- Number of drop-out participants(Up to 6 months)
- Changes in levels of total cholesterol(Baseline up to 6 months)
- Changes in levels of markers of inflammation (leptin)(Up to 6 months)
- Changes in levels of HDL-cholesterol(Baseline up to 6 months)
- Changes in levels of markers of inflammation (C-reactive protein)(Up to 6 months)
- Changes in levels of LDL-cholesterol(Baseline up to 6 months)
- Number of Participant with reported side effects(Up to 6 months)
- Changes in levels of markers of inflammation (interleukin 6)(Up to 6 months)
- Changes in levels of triglycerides(Baseline up to 6 months)
- Average percentage of positive urinary ketone tests as a marker of dietary adherence(Up to 6 months)
- Changes in levels of markers of inflammation (tumor necrosis factor - alpha)(Up to 6 months)
- Changes in quality-of-life as assessed by the Obesity and Weight Loss Quality-of-Life Questionnaire(Baseline up to 6 months)