Aging Clinical Trial
— BIKEOfficial title:
A Randomized, Double-blind, Placebo-controlled, Parallel Group, Feasibility Pilot Study to Evaluate the Tolerability and Safety of a Novel Ketone Ester Ingredient in Healthy Older Men and Women.
Verified date | January 2024 |
Source | Buck Institute for Research on Aging |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is to investigate the tolerability and safety of a ketone promoting ingredient, called a ketone ester (KE), in healthy older adults. This randomized, double-blind, placebo-controlled trial aims to characterize the tolerability and safety of daily consumption of the KE in healthy older adults (over 65 years old) over 12 weeks. Study participants will complete Beverage Tolerability Questionaires (BTQ) to rate any side side effects throughout the study. Safety will also be assessed by collection of blood and urine samples, vital signs, body weight, and monitoring of adverse events (AEs). The study will also collect pilot data to explore possible effects of KE on physical function, cognitive function and quality of life. The findings of this study will be used to facilitate future mechanistic studies of KE in aging.
Status | Completed |
Enrollment | 30 |
Est. completion date | January 17, 2024 |
Est. primary completion date | December 13, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria: 1. Subject is greater than or equal to 65 years of age, inclusive at Visit 1. 2. Subject has a BMI 18.5-34.9 kg/m2 (inclusive) at Visit 1. 3. Subject is willing and able to comply with all study procedures including randomization into any of the experimental groups, maintenance of habitual dietary intake, exercise and medication and supplement use, blood draws and the following prior to test visits: fasting (=10 h; water and black coffee only), no alcohol (= 10 h), no cannabis products (=10 h) and no exercise (= 10 h). 4. Subject has no health conditions that would prevent them from fulfilling the study requirements as judged by the Clinical Investigator on the basis of medical history and routine laboratory test results. 5. Subject understands the study procedures and signs forms providing informed consent to participate in the study. Exclusion Criteria: 1. Subject is non ambulatory 2. Subject has a CSHA clinical frailty score > 5 3. Subject requires assistance with any activity of daily living 4. Subject lives in an institutional setting (skilled nursing facility or residential care facility for the elderly). 5. Subject is a female who has not passed menopause. 6. Subject is unable to converse in English 7. Subject is unable to provide informed consent due to cognitive impairment or insufficient English language comprehension 8. Subject has been hospitalized within 30 days of Visit 1, 2 or 3. 9. Subject has an abnormal laboratory test result(s) of clinical importance, indicating unstable chronic disease of major organ dysfunction, at Visit 1, at the discretion of the Medical Officer. One re-test will be allowed on a separate day prior to Visit 2, for subjects with abnormal laboratory test results. 10. Subject has a history or presence of uncontrolled and/or clinically active pulmonary, cardiac (e.g. >= New York Heart Association class III), hepatic, renal, endocrine (including type 1 diabetes), hematologic, immunologic, neurologic (e.g., Alzheimer's or Parkinson's diseases), psychiatric (including unstable depression and/or anxiety disorders) or biliary disorders. Stable chronic disease is not an exclusion criterion unless specified. 11. Subject has a clinically important gastrointestinal condition that would potentially interfere with the evaluation of the study beverage [e.g., inflammatory bowel disease, irritable bowel syndrome, chronic constipation, severe constipation (in the opinion of the Clinical Investigator), history of frequent diarrhea, history of surgery for weight loss, gastroparesis, systemic disease that might affect gut motility according to the Investigator, reflux requiring daily medication, history of gastrointestinal ulcers or bleeding, and/or clinically important lactose intolerance]. 12. Subject has a history of alcohol or substance abuse. 13. Subject is consistently using prescriptive or over-the counter medications where alcohol is a contraindication at the discretion of the Investigator. 14. Subject has a known allergy, intolerance, or sensitivity to any of the ingredients in the study beverages, including soy and milk protein. 15. Subject has uncontrolled hypertension (systolic blood pressure =140 mm Hg or diastolic blood pressure =90 mm Hg) as defined by the blood pressure measured at Visit 1. One re-test will be allowed on a separate day before Visit 2, for subjects with abnormal blood pressure. 16. Subject is undergoing treatment or active surveillance for cancer, or has been diagnosed with cancer in the prior two years, except for non-melanoma skin cancer. 17. Subject has recently used antibiotics within 30 days of Visit 1, 2 or 3. 18. Subject has extreme dietary habits (e.g., intermittent fasting or time restricted eating, Atkins diet, vegan, very high protein/low carbohydrate or has used weight-loss medications (including over-the-counter medications and/or supplements) or programs within 30 days of Visit 1, 2 or 3. 19. Subject has used medications (over-the-counter or prescription) known to influence gastrointestinal function including, but not limited to, opioids, weight loss medications, antidiarrheals, and antispasmodics) within 30 days of Visit 1, 2 or 3. 20. Subject has used ketone supplements (ketone salts or esters, and medium chain triglycerides [MCT]) within 30 days of Visit 1, 2 or 3. 21. Subject has unstable use of thyroid, antihypertensive, antidepressant, or statin medications within 30 days of Visit 1, 2 or 3. 22. Subject has a condition the Clinical Investigator believes would interfere with their ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the subject at undue risk. 23. Subject works nights or shifts that means it is not possible to maintain a consistent meal schedule during the study. 24. Subject is not permitted to visit the Buck Institute campus, for example due to inability to confirm COVID-19 vaccination status. 25. Subject does not have a Bluetooth enabled smartphone. 26. Subject does not have access to the internet |
Country | Name | City | State |
---|---|---|---|
United States | Buck Institute for Research on Aging | Novato | California |
Lead Sponsor | Collaborator |
---|---|
Buck Institute for Research on Aging | Biofortis Mérieux NutriSciences |
United States,
Chen O, Blonquist TM, Mah E, Sanoshy K, Beckman D, Nieman KM, Winters BL, Anthony JC, Verdin E, Newman JC, Stubbs BJ. Tolerability and Safety of a Novel Ketogenic Ester, Bis-Hexanoyl (R)-1,3-Butanediol: A Randomized Controlled Trial in Healthy Adults. Nutrients. 2021 Jun 16;13(6):2066. doi: 10.3390/nu13062066. — View Citation
Crabtree CD, Blade T, Hyde PN, Buga A, Kackley ML, Sapper TN, Panda O, Roa-Diaz S, Anthony JC, Newman JC, Volek JS, Stubbs BJ. Bis Hexanoyl (R)-1,3-Butanediol, a Novel Ketogenic Ester, Acutely Increases Circulating r- and s-ss-Hydroxybutyrate Concentrations in Healthy Adults. J Am Nutr Assoc. 2023 Feb;42(2):169-177. doi: 10.1080/07315724.2021.2015476. Epub 2022 Mar 25. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in Short Physical Performance Battery Score | Standard set of tests to measure physical function in elderly | Measured at baseline (Week 0) and final visit (Week 12) | |
Other | Change in 1 rep max leg press | Heaviest weight moved using leg press machine | Measured at baseline (Week 0) and final visit (Week 12) | |
Other | Change in Sub maximal leg press to fatigue | Number of reps completed at a sub maximal weight | Measured at baseline (Week 0) and final visit (Week 12) | |
Other | Change in 6 minute walk test | Distance covered when walking for 6 minutes | Measured at baseline (Week 0) and final visit (Week 12) | |
Other | Change in Grip strength | Hand grip force measured by dynamometer | Measured at baseline (Week 0) and final visit (Week 12) | |
Other | Change in Montreal Cognitive Assessment score | Standard test for cognitive function in elderly | Measured at baseline (Week 0) and final visit (Week 12) | |
Other | Change in Digit Symbol Substitution Task scores | Task where participant substitutes numbers for symbols in a set time | Measured at baseline (Week 0) and final visit (Week 12) | |
Other | Change in Trails A and B scores | Standard trail making test scores between letters and numbers | Measured at baseline (Week 0) and final visit (Week 12) | |
Other | Change in score on Profile of Mood States (Short form) Questionnaire | Questionnaire | Measured at baseline (Week 0) and final visit (Week 12) | |
Other | Change in score on The Sexual Quality of Life Questionnaire | Questionnaire | Measured at baseline (Week 0) and final visit (Week 12) | |
Other | Change in score on the Short Form Health Survey-36 | Questionnaire | Measured at baseline (Week 0) and final visit (Week 12) | |
Other | Change in score on the Pittsburgh Sleep Quality Index | Questionnaire. | Measured at baseline (Week 0) and final visit (Week 12) | |
Other | Change in score on the Pittsburgh Fatiguability Scale | Questionnaire | Measured at baseline (Week 0) and final visit (Week 12) | |
Other | Change in score on the Geriatric Depression Scale | Questionnaire | Measured at baseline (Week 0) and final visit (Week 12) | |
Other | Changes in gut microbial diversity | DNA sequencing of bacterial species in stool samples. | Change from pre-test to week 1, week 4 and week 12. | |
Other | Ketone changes 4h after powder formulation of ketone drinks | Subjects consume a single serving of either 12.5 g or 25 g of powder formulation ketone ester. After this, their short-term (regularly over 4h) blood ketone changes are measured using capillary blood sampling. | 4h | |
Primary | Tolerance | The primary outcome measure is the proportion of subjects reporting the same moderate to severe symptom (among dizziness, headache or nausea) occurring on more than one day within any given recall period (after week 0 - 2 acclimation period) when ketone esters are consumed daily for 12 weeks. | 12 weeks | |
Secondary | Safety Blood Profile | Change from baseline to week 4 and week 12 in the incidence of abnormal laboratory test results | Change from baseline to week 4, and week 12. | |
Secondary | Ketone changes 4h after ketone ester drinks | Subjects consume a single serving of either 12.5 g or 25 g of ketone ester. After this, their short-term (regularly over 4h) blood ketone changes are measured using capillary blood sampling. | 4 hours |
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