Ketone Ester Effects on Biomarkers of Brain Metabolism and Cognitive Performance in Cognitively Intact Adults 55 Years Old or Older
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|ClinicalTrials.gov Identifier: NCT04421014|
Recruitment Status : Recruiting
First Posted : June 9, 2020
Last Update Posted : July 8, 2020
In Alzheimer s disease (AD) the brain cannot use glucose as a fuel. The brain can use ketones as a fuel instead of glucose. Researchers want to test a supplement, HVNM Ketone Ester (KE). It may improve brain metabolic function and cognition in normal people and, perhaps, down the road, in patients with AD.
To study the change in brain ketone levels in people after 28 days of taking HVMN KE compared with baseline and placebo. Also, to study changes in cognitive performance.
People 55 years old or older with metabolic syndrome and no cognitive impairment
Participants will have 4 visits.
Participants will be screened at Visit 1 with:
Blood and urine tests
Participants will be randomly assigned to receive either the study supplement or a placebo with same amount of calories. Neither they nor the researchers will know which they receive.
Visit 2 will include repeats of some screening tests. It will also include:
Stool sample (brought from home)
MRI/MRS: Participants will lie on a table that slides in and out of a scanner. A coil will be placed over their head. They may be asked to perform leg exercises.
First dose of study supplement or placebo
About 2 weeks after Visit 2, Visit 3 will include blood and urine tests and a questionnaire.
About 2 weeks after Visit 3, Visit 4 will include repeats of the Visit 2 tests.
Participants will drink the study supplement or placebo 3 times per day during the study. They will keep a daily log of each dose. They will bring the log to Visits 3 and 4.
Participants will by contacted by phone once per week during the study to see how they are doing.
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Syndrome Normal Cognition||Dietary Supplement: HVMN Ketone Esther drink Dietary Supplement: Placebo: isocaloric dextrose drink||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Ketone Ester Effects on Biomarkers of Brain Metabolism and Cognitive Performance in Cognitively Intact Adults More Than or Equal to 55 Years Old or Older. A Double-Blinded Randomized Controlled Clinical Trial.|
|Estimated Study Start Date :||July 13, 2020|
|Estimated Primary Completion Date :||September 1, 2021|
|Estimated Study Completion Date :||April 30, 2022|
Active Comparator: HVMN Ketone Ester/ Arm 1
Dietary Supplement: HVMN Ketone Esther drink
The main ingredient of HVMN Ketone Ester [(R)-3- hydroxybutyl (R)-3- hydroxybutyrate)] is regulated as GRAS (Generally Recognized as Safe) substance by the FDA (https://www.accessdata .fda.gov/ scripts/ fdcc/index.cfmset=GRASNotices&id=515). The HVMN KE compound is already being sold in the market as a ketogenic supplement and is especially popular among athletes, such as cyclists (sold by the official website of the company (https://hvmn.com/ketone-ester) and in a popular selling website (https://www.amazon.com/HVMN (NotEqual)Ketone-Pocket-Sized (NotEqual)Sugar-Free (NotEqual)Performance/dp/ B07CTP3XST). The dose and formulation (25 g of KE contained in 65 ml of the drink HVMN KE), daily scheme (3 times daily) and total duration (28 days) are identical to a previous safety human study.
Placebo Comparator: Placebo/ Arm 2
Dietary Supplement: Placebo: isocaloric dextrose drink
The main content of the Placebo will be an aqueous solution containing ~ 35 g of dextrose. To better match the taste of the placebo to that of the HVMN KE, we will add a fruity flavor powder (provided by HVMN) and stevia. We will also add Denatonium Benzoate (Bittrex) to match the bitterness of HVMN KE. The placebo will be prepared and dispensed by the NIA Pharmacist.
- Brain concentration of BHB using brain Magnetic Resonance Spectroscopy [ Time Frame: 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). ]To detect with brain MRS, a significant change in the concentration of BHB, after 28 days of supplementation with the HVMN KE compared to baseline and placebo.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04421014
|Contact: Dimitrios I Kapogiannis, M.D.||(410) firstname.lastname@example.org|
|United States, Maryland|
|National Institute of Aging, Clinical Research Unit||Recruiting|
|Baltimore, Maryland, United States, 21224|
|Contact: Dimitrios Kapogiannis, M.D. 410-350-3953 email@example.com|
|Principal Investigator:||Dimitrios I Kapogiannis, M.D.||National Institute on Aging (NIA)|