NCT06682390Toboroz
Role of Race in Nutritional Approach in Men on ADT
Contribution of Race to Nutritional Approach to Lower Cardiovascular Risk Factors in Men Undergoing Androgen Deprivation Therapy
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. dec. 15.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 70 (tervezett)
- Első benyújtás
- 2024. nov. 7.
- Kezdés
- 2024. márc. 28.
- Elsődleges befejezés
- 2027. nov. 20.
- Fő szponzor
- University of California, Los Angeles
- Betegségek
- Prosztatarák
- NCT-szám
- NCT06682390
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 70
- 2024. márc. 28. és az elsődleges befejezés (2027. nov. 20.) között
- 2 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Radiation or chemotherapy treatment
Más betegség
- History of diabetes or serious medical condition including uncontrolled hypertension, liver, kidney, and cardiovascular disease
Laborértékek
- Any subject with a screening laboratory value outside of the laboratory normal range that is considered clinically significant for study participation by the investigator
Egyéb
- Life expectancy < 1 year
- Females
- 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
Kiket keres a vizsgálat
- >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
Életkor a regiszterben: 18 év – - · Nem: csak férfiak · Egészséges önkénteseket nem fogad
Helyszínek (2)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| UCLA Health 200 Medical Plaza | Los Angeles | Egyesült Államok | Toboroz |
| Greater Los Angeles Division of Veterans Affairs | Los Angeles | Egyesült Államok | Toboroz |
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