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Ketone Ester

Ketone Ester for Metabolic Syndrome

N/A

Recruiting

Led By Dimitrios I Kapogiannis, M.D.

Research Sponsored by National Institute on Aging (NIA)

Eligibility Criteria Checklist

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

Must have

Male or female, age >=55 years old

Presence of Metabolic Syndrome (MetS) meeting specific diagnostic criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 days - outcome assessed at visit 2 (baseline measurement before the first dose and after 75 min); visit 4 (before and after 75 min from last dose).

Awards & highlights

Study Summary

This trial is testing whether a supplement can improve brain function by looking at changes in ketone levels and cognition in people with metabolic syndrome.

Who is the study for?

Adults aged 55 or older with metabolic syndrome but no cognitive impairment can join this study. They must be able to consent, take oral meds, and follow the study plan including MRI/MRS scans. Excluded are those with significant psychiatric conditions, certain infections, on metformin or non-English speakers.Check my eligibility

What is being tested?

The trial is testing if a Ketone Ester (KE) drink improves brain metabolism and cognition compared to a placebo in healthy adults. Participants will not know which they're getting and will have multiple visits for tests like MRIs and cognitive assessments over 28 days.See study design

What are the potential side effects?

Potential side effects of the KE drink may include digestive discomfort due to its ingredients. Since it's designed as a supplement, severe reactions are unlikely but could involve allergic responses for those sensitive to ketogenic supplements or stevia.

Eligibility Criteria

Inclusion Criteria

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

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I am 55 years old or older.

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I have been diagnosed with Metabolic Syndrome.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days - outcome assessed at visit 2 (baseline measurement before the first dose and after 75 min); visit 4 (before and after 75 min from last dose).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 days - outcome assessed at visit 2 (baseline measurement before the first dose and after 75 min); visit 4 (before and after 75 min from last dose).

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days - outcome assessed at visit 2 (baseline measurement before the first dose and after 75 min); visit 4 (before and after 75 min from last dose). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Brain concentration of BHB using brain Magnetic Resonance Spectroscopy

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Ketone Ester drink/ Arm 1Active Control1 Intervention

25 participants

Group II: Placebo/ Arm 2Placebo Group1 Intervention

25 participants

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)Lead Sponsor

1,675 Previous Clinical Trials

28,020,735 Total Patients Enrolled

12 Trials studying Metabolic Syndrome

5,332 Patients Enrolled for Metabolic Syndrome

Dimitrios I Kapogiannis, M.D.Principal InvestigatorNational Institute on Aging (NIA)

3 Previous Clinical Trials

261 Total Patients Enrolled

Media Library

HVMN Ketone Esther drink (Ketone Ester) Clinical Trial Eligibility Overview. Trial Name: NCT04421014 — N/A

Metabolic Syndrome Research Study Groups: Ketone Ester drink/ Arm 1, Placebo/ Arm 2

Metabolic Syndrome Clinical Trial 2023: HVMN Ketone Esther drink Highlights & Side Effects. Trial Name: NCT04421014 — N/A

HVMN Ketone Esther drink (Ketone Ester) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04421014 — N/A

Metabolic Syndrome Patient Testimony for trial: Trial Name: NCT04421014 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this experiment open to volunteers at the moment?

"Affirmative, according to clinicaltrials.gov this experiment is actively seeking recruits. This research was first shared on June 24th 2021 and last updated on October 28th 2022, with the aim of recruiting 150 volunteers from a single location."

Answered by AI

What is the current participant count of this clinical experiment?

"Affirmative. Clinicaltrials.gov records demonstrate that this clinical trial is actively recruiting candidates, with the initial post dating back to June 24th 2021 and a most recent update on October 28th 2022. 150 patients have been requested from 1 location for participation in this research project."

Answered by AI