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Ketone Ester

Ketone Supplements for High Blood Pressure (KEAS Trial)

N/A

Recruiting

Led By Austin T Robinson, PhD

Research Sponsored by Auburn University

Eligibility Criteria Checklist

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

Must have

BMI below 35 kg/m2 (or otherwise healthy)

Free of any metabolic disease (diabetes or renal), pulmonary disorders (COPD or cystic fibrosis), cardiovascular disease (peripheral vascular, cardiac, or cerebrovascular), no autoimmune diseases, and no history of cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-intervention (14 days)

Awards & highlights

KEAS Trial Summary

This trial is investigating whether ketone supplements could help reduce the risk for chronic kidney disease and cardiovascular disease caused by high dietary salt.

Who is the study for?

This trial is for healthy young adults aged 18-39 without major health issues like heart disease, cancer, diabetes, or obesity. Participants must be able to cycle on an exercise bike and have a resting blood pressure no higher than 150/90 mmHg and BMI below 35 kg/m2.Check my eligibility

What is being tested?

The KEAS study tests if ketone supplements can protect against the negative effects of high salt intake on blood pressure and kidney function in young adults. It compares the impact of different combinations of dietary salt and β-OHB (a type of ketone) levels.See study design

What are the potential side effects?

While not explicitly stated, potential side effects may include changes in blood pressure or digestive discomfort due to diet alterations. Ketone supplementation could also cause minor side effects such as bad breath or stomach upset.

KEAS Trial Eligibility Criteria

Inclusion Criteria

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

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My BMI is under 35, or I am healthy despite my BMI.

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I don't have diabetes, kidney issues, lung problems, heart diseases, autoimmune conditions, or a history of cancer.

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I can give blood without any health or medication issues.

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I am between 18 and 39 years old.

KEAS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-intervention for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Blood pressure reactivity responses

Flow mediated dilation (FMD)

Leg

+2 more

Secondary outcome measures

Cardiorespiratory fitness

Body Weight Changes

Changes in circulating reactive oxygen species

+10 more

KEAS Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: High Salt, High β-OHBExperimental Treatment1 Intervention

Participants will consume the supplemental intervention for 10 days. On day 10 participants will arrive at the laboratory where the investigators will assess resting blood pressure, arterial stiffness, endothelial function, renal blood flow, and submaximal exercise blood pressure reactivity. Blood will be collected to investigate inflammatory and immune responses to the dietary conditions. Starting on day 9, participants will undergo ambulatory blood pressure monitoring and 24-hour urine collection.

Group II: High Salt, No β-OHBActive Control1 Intervention

Group III: No Salt, No β-OHBPlacebo Group1 Intervention

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of UtahOTHER

1,099 Previous Clinical Trials

1,778,687 Total Patients Enrolled

Auburn UniversityLead Sponsor

72 Previous Clinical Trials

14,370 Total Patients Enrolled

University of Missouri-ColumbiaOTHER

361 Previous Clinical Trials

627,959 Total Patients Enrolled

Media Library

β-OHB (Ketone Ester) Clinical Trial Eligibility Overview. Trial Name: NCT05545501 — N/A

High Blood Pressure Research Study Groups: High Salt, No β-OHB, No Salt, No β-OHB, High Salt, High β-OHB

High Blood Pressure Clinical Trial 2023: β-OHB Highlights & Side Effects. Trial Name: NCT05545501 — N/A

β-OHB (Ketone Ester) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05545501 — 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 open for this research study?

"This medical trial is seeking 35 hypertensive individuals, between 18 and 39 years old. To qualify for the study, potential participants must adhere to a number of key criteria: Resting blood pressure not beyond 150/90 mmHg; BMI below 35 kg/m2 (or otherwise healthy); No precluding medications or conditions (e.g., Pradaxa, Eliquis, hemophilia); Ability to cycle on an exercise bike for up to one hour at a time; Lack of metabolic diseases (diabetes or renal issues), pulmonary disorders (COPD or cystic fibrosis), cardiovascular disease (peripheral"

Answered by AI

Does this research project need additional volunteers for participation?

"As evidenced on clinicaltrials.gov, this research has ceased its recruitment of participants; originally posted October 1st 2022 and most recently updated September 15th 2022. However, there are still 747 other studies actively enrolling patients at present."

Answered by AI

What is the aim of this experiment?

"The main objective of this trial, which spans 10-day intervention periods and evaluates Passive Leg Movement, is to assess the effect of changing from low salt to high salt diets supplemented with ketones. Secondary outcomes include Inflammatory Cell Responses towards Conditions, Objective Sleep Efficiency determined through Philips Actiwatch Spectrum analysis over a span of 14 days as well as calculating sleep duration by cross-checking actigraphy wear times against a Sleep Diary."

Answered by AI