Effect of Resveratrol on Serum IGF2 Among African American Women

NCT04266353 | Withdrawn

• 1 other identifier: 5160378
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chemoprevention

Outcome Measures

Primary Outcomes (1)

• IGF2 assessment by Elisa assays

  To determine changes in the levels of IGF-II (mIGF2 or Pro-IGF2)

  Week 0, 2, 4 6

Secondary Outcomes (1)

• IGFBP-3 assessment by Elisa assays

  Week 0, 2, 4, 6

Study Arms (1)

Single arm

EXPERIMENTAL

Participants with receive resveratrol at 150 mg daily for 6 weeks

Dietary Supplement: Resveratrol (RSV)

Interventions

Resveratrol (RSV) DIETARY_SUPPLEMENT

Participants will receive Resveratrol at 150 mg daily for 6 weeks.

Also known as: ResVida

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Cancer Center

Loma Linda, California, 92350, United States

Location

MeSH Terms

Interventions

Resveratrol

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols

Study Officials

• Gayathri Nagaraj, MD

  Loma Linda University Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: February 12, 2020
• Study Start: April 24, 2019
• Primary Completion: August 22, 2022
• Study Completion: August 22, 2022
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)