Prevention of Age-associated Cardiac and Vascular Dysfunction Using Avmacol ES

NCT05408559 | Recruiting Phase 1 FDA Drug

• 1 other identifier: L22-024
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Our local IRB approved clinical studies seeking proof of principle for the hypothesis that SFN can be safely administered to humans at doses sufficient to protect age-associated cardiac dysfunctions. Beneficial effects of SFN-therapy will be assessed by Pre- and post-intervention echocardiography, and exercise endurance at 0 and 24 weeks. Peripheral blood cells from treated and control subjects will be compared for mitochondrial respiratory function, oxidative damage, pro-inflammatory cytokines, and expression of antioxidant \& anti-electrophile genes.

Conditions

Diastolic Dysfunction; Systolic Dysfunction; Diastolic Heart Failure

Keywords

Sulforaphane; oxidative stress; HFpEF; HFrEF; Arterial function; Muscle function

Outcome Measures

Primary Outcomes (4)

• cardiac function

  1. LV ejection fraction at baseline and 24 weeks 2. Left ventricular global longitudinal strain at baseline and 24 weeks 3. Left ventricular diastolic function at baseline and 24 weeks

  0 week

• cardiac function

  1. LV ejection fraction at baseline and 24 weeks 2. Left ventricular global longitudinal strain at baseline and 24 weeks 3. Left ventricular diastolic function at baseline and 24 weeks

  24 week

• Functional Capacity

  Exercise capacity in METS at baseline and 24 weeks

  0 week

• Functional Capacity

  Exercise capacity in METS at baseline and 24 weeks

  24 week

Secondary Outcomes (4)

• Muscle Function

  0 week

• Muscle Function

  24 week

• Hand grip test

  0 week

• Hand grip test

  24 week

Other Outcomes (2)

• DNA damage, CBC, Oxidative stress

  0 week

• DNA damage, CBC, Oxidative stress

  24 weeks

Study Arms (2)

Avmacol ES

ACTIVE COMPARATOR

Processed SFN-rich extract will be purchased from Nutramax Laboratories, Inc. 2208 Lakeside Blvd Edgewood, MD 21040. Caplets containing SFN-rich broccoli sprout extracts will be obtained from Nutramax Labs. Study medication will be dispensed in sealed bottles with instructions to keep them in a household freezer. The size of the caplet will be about the size of a 1000 mg Vit C pill (about 2 cm in length). The participants will be dosed, based on weight, in a double-blind fashion with identical appearing placebo or SFN caplets. Participants will be instructed to take a daily dose for 24 weeks based on the participants weight. Two caplets for individuals \<100 lb., three caplets for individuals 100-200 lb. and four caplets for individuals \>200 lb. SFN (Avmacol Extra Strength) will be prescribed by a study physician, and will be dispensed by the study coordinators at TTUHSC Lubbock. Pill counts will be conducted to demonstrate compliance.

Drug: Sulforaphane

Placebo

PLACEBO COMPARATOR

Placebo caplets containing microcrystalline cellulose will be obtained from Nutramax Labs. Study medication will be dispensed in sealed bottles with instructions to keep them in a household freezer. The size of the caplet will be about the size of a 1000 mg Vit C pill (about 2 cm in length). The participants will be dosed, based on weight, in a double-blind fashion with identical appearing placebo or SFN caplets. Participants will be instructed to take a daily dose for 24 weeks based on the participants weight. Two caplets for individuals \<100 lb., three caplets for individuals 100-200 lb. and four caplets for individuals \>200 lb. Placebo will be prescribed by a study physician, and will be dispensed by the study coordinators at TTUHSC Lubbock. Pill counts will be conducted to demonstrate compliance.

Drug: Sulforaphane

Interventions

Sulforaphane DRUG

Caplets containing SFN-rich broccoli sprout extracts or placebo caplets containing microcrystalline cellulose will be obtained from from Nutramax Labs.

Also known as: Avmacol Extra Strength

Avmacol ES; Placebo

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 60 years
• Diagnosis of HFpEF (HF symptoms with a normal EF (\>/=50 %)
• Ability to walk more than 500 feet (by self-report)
• Willing to avoid taking all over the counter antioxidant phytochemical supplements (vegetable or fruit-containing supplement pills) during the study

You may not qualify if:

• Inability to provide informed consent
• Diagnosis of active cancer
• Inability to read and understand the SF-36 in English
• Participants using over the counter antioxidant supplements
• Participants with pulmonary or other issues which restrict walking capacity
• On oxygen therapy

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead

Study Sites (1)

Texas Tech University Health Sciences Center (TTUHSC)

Lubbock, Texas, 79430, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure, Diastolic

Interventions

sulforaphane

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Sharda P Singh, PhD

CONTACT

806-743-1540; sharda.singh@ttuhsc.edu

Pooja Sethi, MD

CONTACT

806-743-1501; pooja.sethi@ttuhsc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: These potential subjects will be recruited in a randomized, controlled, double blinded pilot study comparing SFN to placebo.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Well trained Nurses of Clinical Research Institute, TTUHSC will receive placebo and test compound from supplier and will dispense them to test subjects.

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: June 7, 2022
• Study Start: July 1, 2022
• Primary Completion: August 30, 2025
• Study Completion (Estimated): July 30, 2026
• Last Updated: November 6, 2024

Record last verified: 2024-11

Locations

US (1)