Contribution of Race to Nutritional Approach to Lower Cardiovascular Risk Factors in Men Undergoing Androgen Deprivation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 4
- 主要终点
- Fat mass
研究概览
简要总结
There is a well-documented association between androgen deprivation therapy (ADT) and cardiovascular morbidity. A majority of men on ADT gain weight contributing to an increase in cardiovascular risk factors (CVRFs) and cardiovascular morbidity. Dietary intervention combined with exercise have shown success in reducing weight/fat mass and improving cardiovascular risk factors (CVRF). There is little data on whether African American men would respond to diet and exercise interventions differently from non-Hispanic white men. We will conduct a pilot, controlled two-phase intervention study stratified by race to investigate the following objectives:
- Compare effect of a hypocaloric, anti-inflammatory diet on changes in fat mass between African- American vs non-Hispanic white men with metastatic prostate cancer on ADT therapy.
- Compare effect of a hypocaloric, anti-inflammatory diet on changes in cardiovascular risk factors (body weight, lean body mass, waist-to-height ratio, blood pressure, lipids and HbA1C) and inflammatory markers (hs-CRP and cytokines) between African-American vs non-Hispanic white men with metastatic prostate cancer on ADT therapy.
- Compare effect of a hypocaloric, anti-inflammatory diet on changes in cancer-related fatigue and quality of life between African-American vs non-Hispanic white men with metastatic prostate cancer on ADT therapy.
We will enroll 35 African American and 35 non-Hispanic white men with prostate cancer undergoing ADT therapy. In phase 1, after baseline assessment, men will consume their habitual diet and continue their habitual activity level for 3 months. During phase 2, participants will be instructed to consume a hypocaloric (-500 kcal), anti- inflammatory diet and walk for 1 hour on 3 days per week for 3 months. At baseline, after phase 1 and 2 primary outcome (fat mass) and secondary outcomes (CVRF and inflammatory markers) and tertiary outcomes (cancer-related fatigue and quality of life) will be determined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •>12 months on ADT
- •Expected continuation of ADT for >6 months upon initiation of study procedures
- •Serum testosterone <50 ng/dL
- •Age >18 years old
- •African American and Non-Hispanic white males
- •Subjects must read and sign the Institutional Review Board-approved written informed consent prior to the initiation of any study specific procedures or enrollment. A subject will be excluded for any condition that might compromise the ability to give truly informed consent
排除标准
- •Life expectancy < 1 year
- •Radiation or chemotherapy treatment
- •History of diabetes or serious medical condition including uncontrolled hypertension, liver, kidney, and cardiovascular disease
- •Any subject with a screening laboratory value outside of the laboratory normal range that is considered clinically significant for study participation by the investigator
- •Any subject who currently uses tobacco products
- •Any use of >20 g of alcohol per day
- •Any subject who is unable or unwilling to comply with the study protocol
- •Any subject who is unable to provide consent
研究组 & 干预措施
Hypocaloric anti-inflammatory diet
Participants will follow a hypocaloric anti-inflammatory diet for the last 3 months of the study.
干预措施: Hypocaloric anti-inflammatory diet (Behavioral)
Habitual dietary and physical activity regimen
Participants will maintain their habitual dietary and physical activity regimen for the first 3 months of the study.
结局指标
主要结局
Fat mass
时间窗: At baseline, 3 months and 6 months
Bioelectric impedance measurement will provide information about body composition including percent body fat, fat mass, lean body mass, total body water and basal metabolic rate using the portable BIA310e (Biodynamics Corp.). BIA is based on the principle that the flow of an electrical current through an object can be used to determine the object's physical properties.
Waist circumference
时间窗: At baseline, 3 months and 6 months
Waist circumference will be measured with a tape measure in standing position horizontally, just above the hip bone, without compressing the skin.
次要结局
- Blood lipids and lipoproteins (triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol)(At baseline, 3 months and 6 months)
- HbA1c(At baseline, 3 months and 6 months)
- Total testosterone(At baseline, 3 months and 6 months)
- Inflammatory markers (hs-CRP, IL-6, IL-1b, TNFa)(At baseline, 3 months and 6 months)
- Serum free fatty acids(At baseline, 3 months and 6 months)
- Diet and physical activity(At baseline, 3 months and 6 months)
研究者
Zhaoping Li
UCLA Professor of Medicine
University of California, Los Angeles