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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

Must not have

Diabetes Mellitus (type 1 or 2)

Following high fat/low carb diet (ketogenic) diet or very low calorie (<500 calories) diet or taking other ketogenic supplements (such as Medium Chain Triglycerides (MCTs), Ketone Salts) or fasting intermittently and unwilling to stop it while on the KE drink/Placebo

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).

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.

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.

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.

Exclusion Criteria

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

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I have diabetes (type 1 or 2).

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I am on a ketogenic or very low calorie diet, or taking ketogenic supplements, and unwilling to stop while on the trial.

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I weigh less than 300 lbs.

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I have severe high blood pressure.

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I am currently taking metformin.

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I do not speak English.

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I have no history of serious brain disorders or injuries.

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I have difficulty with blood draws or IV insertions due to poor vein access.

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I have anemia.

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I have been diagnosed with a condition that affects my memory or thinking.

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.