What side effects are associated with this type of intervention?

Common treatments for cognitive impairment that focus on enhancing mitochondrial function and reducing inflammation include acetyl-L-carnitine and various antioxidants. Acetyl-L-carnitine has been associated with mild side effects such as nausea, vomiting, and restlessness. Antioxidants like vitamin E are generally well-tolerated but can cause gastrointestinal issues and, in high doses, may increase the risk of hemorrhagic stroke. It is important to consult with a healthcare provider to tailor treatments to individual needs and monitor for adverse effects.

What prior FDA approvals exist?

FDA-approved treatments for cognitive impairment include drugs like aducanumab (Aduhelm®), which targets amyloid plaques in Alzheimer's disease. Additionally, memantine, an NMDA receptor antagonist, is approved for moderate to severe Alzheimer's disease and works by reducing glutamate toxicity, which can help with mitochondrial function. Cholinesterase inhibitors like donepezil, rivastigmine, and galantamine are also approved and work by increasing acetylcholine levels in the brain. While these treatments do not directly focus on improving blood flow or reducing inflammation, they address various aspects of cognitive decline.

What other types of research exist?

Promising novel alternatives to Urolithin A for cognitive impairment patients in 2024 may include: 1) Carnosine, which has shown potential in reducing inflammation and oxidative stress. 2) Fenofibrate, which enhances urate reduction and may have anti-inflammatory properties. 3) Statins, which have been noted to affect uric acid homeostasis and may offer neuroprotective benefits. These alternatives should be discussed with a healthcare provider to determine their suitability and efficacy for cognitive impairment.

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Other

Urolithin A Supplementation for Obesity

N/A

Recruiting

Led By Andriy Yabluchanskiy, MD, PhD

Research Sponsored by University of Oklahoma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age: 40-64 years old, inclusive

Obesity [BMI ≥30 kg/m2]

Must not have

History of hypertension

History of type 1 or type 2 diabetes mellitus

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (day 0) and endpoint (day 28)

Summary

This trial tests if a dietary supplement called urolithin A can improve blood flow in middle-aged adults with obesity. Participants will take the supplement daily for a few weeks, and researchers will compare their blood flow to see if urolithin A helps blood vessels work better and improves overall blood flow. Urolithin A is a metabolite produced in the gut from foods rich in ellagitannins and ellagic acid, such as pomegranates, nuts, and certain berries, and has shown potential benefits for mitochondrial health and muscle performance.

Who is the study for?

This trial is for middle-aged adults (40-64 years old) with obesity, defined as having a BMI of 30 or higher. Participants must be able to understand and consent in English. It's not open to those with cognitive impairments, swallowing issues, recent heart problems, severe mental health conditions like depression or anxiety, significant GI diseases, allergies to the supplement ingredients, active cancer treatment, diabetes history or neurodegenerative disorders.

What is being tested?

The study tests if Urolithin A supplementation can improve blood flow in large and small vessels among obese middle-aged adults. Over four weeks participants will take either this dietary supplement or a placebo daily. Their vascular health will be assessed through two visits involving vessel checks and questionnaires.

What are the potential side effects?

Potential side effects are not detailed here but could include reactions related to individual intolerance to the components of Urolithin A or the placebo substance used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 40 and 64 years old.

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My BMI is 30 or higher.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of high blood pressure.

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I have a history of diabetes.

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I haven't had significant heart problems or chest pain in the last 6 months.

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I have a serious gut condition like IBS or Crohn's disease.

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I am currently receiving treatment for cancer.

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I have a history of a neurodegenerative disorder like multiple sclerosis.

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I have difficulty swallowing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (day 0) and endpoint (day 28)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (day 0) and endpoint (day 28)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 0) and endpoint (day 28) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in arterial function and local stiffness

Secondary study objectives

Change in blood flow on the surface of the hand

Change in homeostatic cerebral blood flow

Change in plasma biomarkers of NO homeostasis

+1 more

Other study objectives

Body fat percentage

Body weight

Waist circumference

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: InterventionExperimental Treatment1 Intervention

Group II: ControlPlacebo Group1 Intervention

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for cognitive impairment work by enhancing neurotransmitter activity, reducing inflammation, and improving blood flow to the brain. Urolithin A, for instance, is being studied for its potential to enhance mitochondrial function and reduce inflammation, which can improve blood flow and overall brain health. These mechanisms are important for cognitive impairment patients as they address the underlying issues contributing to cognitive decline, potentially improving quality of life and slowing disease progression.