An interventional study of Resveratrol (RSV) in Chemoprevention, sponsored by Loma Linda University. Withdrawn at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-09.
Sponsored by Loma Linda University · Not applicable, Interventional, and Other
African American (AA) women with breast cancer (BC) have higher mortality and are associated with worse outcomes when treated with available adjuvant treatments. Addressing this survival disparity will depend on identifying contributing biologic factors that can be translated into new treatments. Preclinical studies have shown that Insulin-like growth factor-II (IGF-II)expression was significantly higher in AA cell lines and tissue samples when compared to Caucasians indicating that IGF-II is an important biologic factor contributing to higher breast cancer mortality in AA women and is also responsible for chemoresistance in BC cells. In addition preclinical studies also demonstrated that resveratrol (RSV) inhibits IGF-II and induces apoptosis in BC cell lines. Researchers want to test IGF-II levels at baseline in healthy African American women and monitor levels while on resveratrol therapy for 6 weeks.
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.
Loma Linda University is the lead sponsor of 297 studies on the registry; 48 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 23 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
EXCLUSION CRITERIA
Participants with receive resveratrol at 150 mg daily for 6 weeks
Dietary Supplement: Resveratrol (RSV)
Participants will receive Resveratrol at 150 mg daily for 6 weeks.
Also known as: ResVida
IGF2 assessment by Elisa assays
To determine changes in the levels of IGF-II (mIGF2 or Pro-IGF2)
Time frame: Week 0, 2, 4 6
IGFBP-3 assessment by Elisa assays
To determine changes in the levels of IGFBP-3 levels
Time frame: Week 0, 2, 4, 6
Plan to share: No
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This study is withdrawn, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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