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| Name | Class |
|---|---|
| National Comprehensive Cancer Network | NETWORK |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Habitual dietary and physical activity regimen | No Intervention | Participants will maintain their habitual dietary and physical activity regimen for the first 3 months of the study. | |
| Hypocaloric anti-inflammatory diet | Experimental | Participants will follow a hypocaloric anti-inflammatory diet for the last 3 months of the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypocaloric anti-inflammatory diet | Behavioral | 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 phytonutrient contents, particularly those rich in phenolic compounds such as ellagitannins and sulforaphanes. Selected herbs (e.g., turmeric, ginger, garlic, black pepper, rosemary, cardamon, cinnamon), green tea, fermented foods, fats (e.g., avocado), and oils (e.g., olive oil) will be encouraged. The goal is to have 5 servings of vegetables, 2 fruits per day, and 5 vegetable color groups per week. Participants will also be asked to reduce their kcal by 500/day and walk for 1 gr 3x per week. |
| Measure | Description | Time Frame |
|---|---|---|
| Fat mass | 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. | At baseline, 3 months and 6 months |
| Waist circumference | Waist circumference will be measured with a tape measure in standing position horizontally, just above the hip bone, without compressing the skin. | At baseline, 3 months and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Blood lipids and lipoproteins (triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol) | Blood lipids and lipoproteins will be analyzed spectrophotometrically using reagent from Pointe Scientific (Canton, MI, USA). | At baseline, 3 months and 6 months |
| HbA1c |
| Measure | Description | Time Frame |
|---|---|---|
| Cancer-related fatigue | Participants will be asked to fill out a questionnaire about cancer-related fatigue. | At baseline, 3 months and 6 months |
| Quality of life | Participants will be asked to fill out a questionnaire about quality of life. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tatiana Diacova, PhD, MS, RDN | Contact | 310-825-8499 | tdiacova@mednet.ucla.edu |
| Name | Affiliation | Role |
|---|---|---|
| Zhaoping Li, MD, PhD | University of California, Los Angeles | Principal Investigator |
| Matthew Rettig, MD | Greater Los Angeles Division of Veterans Affairs, Los Angeles, California 90073 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Greater Los Angeles Division of Veterans Affairs | Recruiting | Los Angeles | California | 90073 | United States |
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HbA1c will be analyzed spectrophotometrically using reagent from Pointe Scientific (Canton, MI, USA). |
| At baseline, 3 months and 6 months |
| Total testosterone | Total testosterone will be analyzed spectrophotometrically using reagent from Pointe Scientific (Canton, MI, USA). | At baseline, 3 months and 6 months |
| Inflammatory markers (hs-CRP, IL-6, IL-1b, TNFa) | Concentrations of hs-CRP and cytokines will be quantified using the MagPix® analyzer (Luminex, Austin TX) with MILLIPLEX MAP Human CVD Panel 3 kit (hs-CRP) and Milliplex Human Cytokine/Chemokine MAGNETIC BEAD kit (IL-6, IL-1β, TNFα,) from EMD Millipore (Billerica, MA) at the Center for Human Nutrition Biomarker Laboratory. | At baseline, 3 months and 6 months |
| Serum free fatty acids | Serum free fatty acids will be measured using an enzymatic colorimetric assay according to manufacturer (Sigma-Aldrich, St. Louis, MI). | At baseline, 3 months and 6 months |
| Diet and physical activity | Participants in both groups will be instructed to use the weekly checklist for logging intake, physical activity and sleep habits. Subjects will be encouraged to track dietary intake as often as possible and mandated to complete 3-day dietary record 2 times every 4 weeks. Activity/exercise and sleep time will be monitored by the provided weekly checklist and ASA-24 at baseline, month 3, and month 6. | At baseline, 3 months and 6 months |
| At baseline, 3 months and 6 months |
| UCLA Health 200 Medical Plaza | Recruiting | Los Angeles | California | 90095 | United States |
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