BridgeMD
New treatment option for Frail Elderly
Official title Targeting Aging With a Ketone Ester for Function in Frailty
ClinicalTrials.gov ID: NCT06645847
What this study is testing
- What it's testing
- This study aims to find out if a food supplement that contains a naturally occurring substance, ketones, can help to improve strength and general wellness in adults at, or over the age of 65 years who are experiencing a slight decline in their physical function. Participation will involve a screening visit and 4 additional study visits over the course of 20 weeks.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older. Healthy volunteers may be eligible.
You may be able to join if
- Subject is greater than or equal to 65 years of age, inclusive at Screening.
- Passes the gait speed criteria at Screening.
- Minimum body weight of 50 kgs at Screening.
- Subject is willing and able to comply with all study procedures including randomization into any of the experimental groups, maintenance of habitual...
- Subject understands the study procedures and can provide informed consent to participate in the study.
You likely can't join if
- Subject is non ambulatory.
- Subject has a CSHA clinical frailty score \> 5.
- Subject requires assistance with any activity of daily living, excluding continence.
- Subject lives in an institutional setting (skilled nursing facility or residential care facility for the elderly).
- Subject is a female who has not passed menopause.
- Subject is unable to converse in English (or Spanish, if available at the study site).
See the full eligibility criteria
- Subject is greater than or equal to 65 years of age, inclusive at Screening.
- Passes the gait speed criteria at Screening.
- Minimum body weight of 50 kgs at Screening.
- 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...
- Subject understands the study procedures and can provide informed consent to participate in the study.
- Subject is non ambulatory.
- Subject has a CSHA clinical frailty score \> 5.
- Subject requires assistance with any activity of daily living, excluding continence.
- Subject lives in an institutional setting (skilled nursing facility or residential care facility for the elderly).
- Subject is a female who has not passed menopause.
- Subject is unable to converse in English (or Spanish, if available at the study site).
- Subject has been hospitalized within 30 days of Screening.
- Subject has any physical limitation that would prevent them from performing 1RM leg press based on Medical Officer judgement.
- Subject has an abnormal laboratory test result(s) of clinical importance at Screening, indicating unstable chronic disease of major organ dysfunction that requires urgent evaluation, at the discretion of the Medical...
- Subject has uncontrolled hypercholesterolemia on screening labs.
- Subject has a history or presence of acute or uncontrolled and/or clinically active pulmonary (chronic obstructive pulmonary disease \>= Gold 3), cardiac (e.g. \>= New York Heart Association class III), hepatic...
- 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...
- Heavy drinking (For women, 8 or more drinks per week. For men, 15 or more drinks per week).
- Subject has a history of alcohol or substance abuse.
- Subject has been instructed not to consume alcohol for medical reasons.
- Subject has a known, clinically important allergy, intolerance, or sensitivity to any of the ingredients in the study beverages, including soy and milk protein.
- Subject has uncontrolled hypertension as defined by the blood pressure measured at Screening. For people with elevated blood pressure at Screening, they are allowed for the purpose of this criteria to submit home...
- 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. Active surveillance is defined as regular imaging or...
- Immunosuppressive disorders, taking immunosuppressive medications (including oral prednisone \>10mg/day and biological immunosuppressants), or receiving chemotherapy.
- Chronic antibiotic use (e.g. expected to be ongoing, regardless of frequency, throughout the study period).
- 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...
- Subject has followed a ketogenic diet or used ketone supplements (ketone salts or esters, and medium chain triglycerides) within 30 days of Screening.
- Subject has a condition the Medical Officer 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...
- Subject works nights or shifts that means it is not possible to maintain a consistent meal schedule during the study.
The study team makes the final eligibility decision.
Where it's taking place
- Novato, California, United States
- Farmington, Connecticut, United States
- Columbus, Ohio, United States
Compensation & support
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Novato, California, United States; Farmington, Connecticut, United States; Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.