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

Part of paid clinical trials in Lubbock, Texas.

Sponsor
Texas Tech University Health Sciences Center
Study ID
NCT05408559
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Diastolic Dysfunction
  • Diastolic Heart Failure
  • Systolic Dysfunction

Eligibility Criteria

Sex
ALL
Age
60 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jul 1, 2022
Status verified
Nov 2024
Primary completion
Aug 30, 2025
Completion
Jul 30, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Avmacol ES
    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.
  • Placebo Comparator: Placebo
    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.

Primary Outcome Measure

cardiac function [ Time Frame: 0 week ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Texas Tech University Health Sciences Center (TTUHSC)LubbockTexas79430
Sharda P Singh, PhD
[email protected]
806-743-1540
Pooja Sethi, MD
[email protected]
806-743-1501
Sharda p singh, PhD (PRINCIPAL_INVESTIGATOR)
scott shurmur, MD (SUB_INVESTIGATOR)
Nandini Nair, MD (SUB_INVESTIGATOR)
Mac Ansari, MD (SUB_INVESTIGATOR)
Pooja Sethi, MD (SUB_INVESTIGATOR)

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