Role of Race in Nutritional Approach in Men on ADT

Официальное название

Contribution of Race to Nutritional Approach to Lower Cardiovascular Risk Factors in Men Undergoing Androgen Deprivation Therapy

Обзор

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: 1. 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. 2. 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. 3. 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.

Вмешательства

• Поведенческое Hypocaloric anti-inflammatory diet
  The anti-inflammatory hypocaloric diet combines the exclusion of pro- inflammatory constituents and inclusion of anti-inflammatory nutrients. Excluded food items will be refined carbohydrates, soda and alcoholic beverages, ultra- processed foods, smoked foods, fatty foods, packaged foods, canned products, preservatives, emulsifiers, and sauces. Reduce or eliminate red/processed meats. Included food items will be a defined minimum diversity of fruits, vegetables, and nuts based on complementary p

Первичные конечные точки

• Fat mass [Срок оценки: At baseline, 3 months and 6 months]
• Waist circumference [Срок оценки: At baseline, 3 months and 6 months]

Вторичные конечные точки (6)

• Blood lipids and lipoproteins (triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol) [Срок оценки: At baseline, 3 months and 6 months]
• HbA1c [Срок оценки: At baseline, 3 months and 6 months]
• Total testosterone [Срок оценки: At baseline, 3 months and 6 months]
• Inflammatory markers (hs-CRP, IL-6, IL-1b, TNFa) [Срок оценки: At baseline, 3 months and 6 months]
• Serum free fatty acids [Срок оценки: At baseline, 3 months and 6 months]
• Diet and physical activity [Срок оценки: At baseline, 3 months and 6 months]

Критерии участия

Критерии включения

• >12 months on ADT
• Expected continuation of ADT for >6 months upon initiation of study procedures
• Serum testosterone <50 ng/dL
• BMI >25
• 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

Критерии исключения

• Life expectancy < 1 year
• Females
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 2 центра

• Greater Los Angeles Division of Veterans Affairs — Los Angeles
• UCLA Health 200 Medical Plaza — Los Angeles

Идентификаторы

NCT: NCT06682390 · 22-001730

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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