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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)
Awards & highlights

Summary

This trial tests if taking a dietary supplement can improve blood flow in middle-aged adults with obesity. Participants will take the supplement and have their blood vessels, blood, and answers to questionnaires checked.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in arterial function and local stiffness
Secondary outcome measures
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 outcome measures
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

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.

Find a Location

Who is running the clinical trial?

Amazentis SAIndustry Sponsor
16 Previous Clinical Trials
1,095 Total Patients Enrolled
University of OklahomaLead Sponsor
457 Previous Clinical Trials
95,701 Total Patients Enrolled
Andriy Yabluchanskiy, MD, PhDPrincipal InvestigatorUniversity of Oklahoma Health Science Center
4 Previous Clinical Trials
286 Total Patients Enrolled

Media Library

Placebo (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05921266 — N/A
Cognitive Impairment Research Study Groups: Control, Intervention
Cognitive Impairment Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05921266 — N/A
Placebo (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05921266 — N/A
~14 spots leftby Dec 2024