NCT04266353

Withdrawn

Effect of Resveratrol on Serum IGF2 Among African American W...

Loma Linda University Source

Loma Linda University

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

5160378

Study Type

interventional

Actual enrollment (reported)

0

Locations

1 country

Sites

1

Timeline

Study Start

April 24, 2019

Actual (reported)

Primary Completion

August 22, 2022

Actual (reported)

Study Completion

August 22, 2022

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: withdrawn
Actual enrollment (reported): 0 participants
Study completion date: August 22, 2022
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
April 24, 2019
Actual (reported)
First Submitted
January 27, 2020
Actual (reported)
First Posted
February 12, 2020
Actual (reported)
Primary Completion
August 22, 2022
Actual (reported)
Study Completion
August 22, 2022
Actual (reported)

Last Updated: May 9, 2023
Status Verified: May 2023
Last Update Submitted: May 8, 2023

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

African American ethnicity self-identified
Female participants aged 18 years and above

Sponsors & Collaborators

Loma Linda University
Otherlead

Study Sites (1)

Loma Linda University Cancer Center

Loma Linda, California, 92350, United States

MeSH Terms

Interventions

Resveratrol

Intervention Hierarchy (Ancestors)

StilbestrolsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolyphenolsPhenols

Study Officials

Gayathri Nagaraj, MD
Loma Linda University Cancer Center
PRINCIPAL INVESTIGATOR

Enrollment

0 participants (actual enrollment reported by the registry).

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

Actual (reported)

NCT00955149

Erlotinib for Chemoprevention in Trisomy 7 Positive Primary Sclerosing Cholangitis (PSC)

Phase 1Completed

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

Contact the study team to confirm eligibility.

Primary Completion

August 22, 2022

Actual (reported)

Study Completion

August 22, 2022

Actual (reported)

Last Updated

May 9, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT04266353
Data provider: ClinicalTrials.gov
Source updated: 2023-05-09
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:19:22 UTC

Locations

US(1)

Study Stopped

Effect of Resveratrol on Serum IGF2 Among African American Women

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Single arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Single arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations