Effect of Resveratrol on Serum IGF2 Among African American Women
Maneno muhimu
Kikemikali
Maelezo
Resveratrol (RSV) is a naturally occurring polyphenol found in many plants including grapes, peanuts and berries. Resveratrol has attracted a lot of research attention based on preclinical data showing anti-inflammatory and anti-oxidative properties through several mechanisms.RSV is available as over the counter supplement in the United States. Various formulations and dosage forms have been used in previous studies involving cardiovascular health, metabolism and chemoprevention. ResVida®, is an oral preparation consisting of pure trans-resveratrol with a purity of > 99% manufactured by DSM nutritional products will be used in this study. Healthy African American women will receive 1 capsule daily of 150 mg.
Objectives: To test the effects of resveratrol on IGF-II level in healthy AA women.
Eligibility: Healthy adult African American female (18 years of age or older) Design: The study involves an initial visit and 3 additional visits at 2 week interval. At the initial visit, women will participate in a short-talk session to present the study, facts about breast cancer, RSV and protocol requirements. Participants will be evaluated for meeting basic eligibility criteria by a Breast Oncologist. All interested participants will sign an informed consent form and will be provided with a questionnaire to complete. The Oncologist will obtain medical history, use of medication, supplements etc. from consented participants. Consented participants will then meet with the study coordinator who will assign each participant with a study identification (ID) number along with other basic assessment as noted below. The study coordinator will also dispense a 2 week supply of RSV along with a medication calendar to each participant at their initial visit and at visits 2-4. In addition, the participants will have their blood sample collected by a trained phlebotomist during visit 1 and at visits 2-4. Collected blood vials will be handed to research laboratory to determine IGF2 levels as well as other research biomarkers.
Tarehe
| Imethibitishwa Mwisho: | 01/31/2020 |
| Iliyowasilishwa Kwanza: | 01/26/2020 |
| Uandikishaji uliokadiriwa Uliwasilishwa: | 02/09/2020 |
| Iliyotumwa Kwanza: | 02/11/2020 |
| Sasisho la Mwisho Liliwasilishwa: | 02/09/2020 |
| Sasisho la Mwisho Lilichapishwa: | 02/11/2020 |
| Tarehe halisi ya kuanza kwa masomo: | 04/23/2019 |
| Tarehe ya Kukamilisha Msingi iliyokadiriwa: | 01/29/2021 |
| Tarehe ya Kukamilisha Utafiti: | 06/29/2021 |
Hali au ugonjwa
Uingiliaji / matibabu
Dietary Supplement: Single arm
Awamu
Vikundi vya Arm
| Mkono | Uingiliaji / matibabu |
|---|---|
| Experimental: Single arm Participants with receive resveratrol at 150 mg daily for 6 weeks | Dietary Supplement: Single arm Participants will receive Resveratrol at 150 mg daily for 6 weeks. |
Vigezo vya Kustahiki
| Zama zinazostahiki Kujifunza | 18 Years Kwa 18 Years |
| Jinsia Inastahiki Kujifunza | Female |
| Hupokea Wajitolea wa Afya | Ndio |
| Vigezo | INCLUSION CRITERIA - African American ethnicity self-identified - Female participants aged 18 years and above - Able to provide written informed consent and to understand, participate and comply with protocol requirements - Able to comprehend and complete forms in English - Able to swallow oral capsules - Willingness to stop dietary supplements and vitamins for the duration of the study - No history of cancers in the past 5 years - Willingness to abstain from ingestion of large quantities of RSV containing foods and less than 3 drinks of wine per week. EXCLUSION CRITERIA - Pregnant or planning to be pregnant or breast feeding - Participating in any other clinical study - History of Diabetes defined as recent A1C greater than 6.5 and or fasting serum glucose greater than or equal to 126 mg/dl - Self-reported history of major organ dysfunction (renal dysfunction described as glomerular filtration rate (GFR) less than 60 ml/min, liver function tests greater than 2 times normal) - Patients on below medications due to potential interactions - Cholesterol medications Atorvastatin (Lipitor), Rosuvastatin (Crestor), Simvastatin (Zocor), Gemfibrozil (Lopid), Niacin (Niacor), etc. - Aspirin greater than 81 mg. Taking medicines that may increase the risk of bleeding such as Coumadin (warfarin), Plavix (clopidogrel), Xarelto (rivaroxaban), Pradaxa (dabigatran), Eliquis (apixaban) or Heparin (blood thinning medications) due to their potential interaction with resveratrol - Chronic (daily) use of non-steroidal anti-inflammatory agents (NSAIDs) such as Motrin (Ibuprofen), Advil (Ibuprofen) or Naprosyn (Naproxen) due to potential interaction with resveratrol. (Occasional use is ok). Anti-diabetic medications: Insulin, Metformin (Glucophage, Avandamet, Glibomet, etc), Rosiglitazone (Avandia), Exenatide (Byetta), Sitagliptin (Januvia), etc. Anti-hypertensive medications Metoprolol (Lopressor), Carvedilol (Coreg), Nifedipine (Procardia, Adalat), Verapamil (Verelan,Calan, Covera), Lisinopril (Prinivil, Zestril), Captopril (Capoten), Losartan (Cozaar), Irbesartan (Avapro), etc. Testosterone and estrogen supplement. Current glucocorticoid use, or up to 3 months ago (nasal, topical, ophthalmic, and inhaled use are not exclusionary) - Participants with other major uncontrolled medical problems or, at the discretion of the PI, Participants on other long term prescription medications for chronic illness - At the discretion of the investigators if considered unfit for the study based on medical or psycho-social conditions - Non-English speaking participants |
Matokeo
Hatua za Matokeo ya Msingi
1. IGF2 assessment by Elisa assays [Week 0, 2, 4 6]
Hatua za Matokeo ya Sekondari
1. IGFBP-3 assessment by Elisa assays [Week 0, 2, 4, 6]
