Recruiting
Not applicable
The Effects of Quercefit® and Ubiqsome™ in Mitigating Inflammation and Promoting Metabolic Health
Condition(s) studied
Healthy AgingInflammagingMetabolic HealthQuercetinCoenzyme Q10
Investigational drug(s) / intervention(s)
Quercetin (dietary supplement)Coenzyme Q10Rice Flour
Quercetin (dietary supplement): Natural compound found in foods like apples and onions that may help reduce inflammation and support overall health.
Coenzyme Q10: Substance made by the body that helps produce energy in cells and also acts as an antioxidant to support heart and overall health.
Rice Flour: An inert carbohydrate used as the control treatment
Study summary
The goal of this clinical trial is to learn if Quercefit® or Ubiqsome™ can improve markers of healthy aging, blood sugar control, and heart health in older adults. It will also learn about the safety of these supplements.
The main questions it aims to answer are:
1. Do Quercefit® or Ubiqsome™ improve blood sugar, cholesterol, and markers of aging compared to a placebo?
2. What side effects, if any, do participants have while taking these supplements?
Researchers will compare Quercefit® (500 mg/day), Ubiqsome™ (300 mg/day), and a placebo (a look-alike capsule with no active ingredient).
Participants will:
1. Take their assigned capsules (Quercefit®, Ubiqsome™, or placebo) twice daily for 12 weeks
2. Go to a preferred clinic at the start and end of the study for a fasting blood draw
Complete at-home tests:
3. Grip strength testing (using a device mailed to them)
4. Online surveys about fatigue and quality of life
5. Report any side effects and keep track of supplement use
Eligibility
Inclusion Criteria:
* Males and females aged 50 to 75 years
* Participants who meet the requirements of a sedentary lifestyle. Meaning, subjects who do not meet the World Health Organization's (WHO) minimum activity guidelines, of at least 150 minutes of moderate-intensity activity, or, 75 minutes of vigorous-intensity activity a week, plus muscle-strengthening activities at least 2 days per week. Of importance, incidental physical activity (eg, walking to work, household activities) would not meet the standard of being physically active according to WHO guidelines (McKay et al., 2021).
* BMI of \> or equal to 25.00kg/m²
* Individuals with \> or equal to 5 score relative to high risk for prediabetes as defined by the CDC (https://www.cdc.gov/prediabetes/takethetest)
* Free of all other chronic diseases.
* Not currently using glucose-lowering agents or insulin.
* Able to read and write in English
* Willing to maintain a habitual diet, supplement routine, and avoid other lifestyle changes during the study period.
* During the study, participants agree not to take any other supplement that can impact glucose or insulin regulation.
* During the study, participants agree not to take any other supplement that can impact cardiovascular health, inflammatory status, or anti-aging supplements
* Willing to have blood drawn
* Must have access to a reliable internet connection and a computer to complete remote assessments
Exclusion Criteria:
* Unwilling to have blood drawn
* Unwilling to swallow pills
* Pregnancy or has breast fed within 3 months prior to enrollment
* Current use of prescription medication or drug that impacts Glucose or Insulin metabolism (including direct insulin treatment) within the past 6-months
* Current use of Quercetine or CoQ10 supplements within the past 4-weeks
* History or current alcohol or drug abuse
* Known diagnosis of any chronic cardiovascular, metabolic, endocrine, or renal disease outside of prediabetes as listed above.
* Has significant concurrent illnesses (controlled or uncontrolled), such as lupus, hepatitis B/C, HIV, serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years, or other conditions, which in the opinion of the investigator, such condition might be aggravated as a result of treatment
* Developmental disability or cognitive impairment that would preclude adequate comprehension of the informed consent form and/or ability to follow study subject requirements and/or record the necessary study measurements.
* History of cardiovascular disease (i.e., myocardial infarction, hypertension, hypercholesterolemia, peripheral vascular disease, other)
* History of neurological disorders (Parkinson's, Amyotrophic lateral sclerosis, epilepsy, spinal cord injury resulting in inability to use upper extremities, other.)
* History of gastrointestinal disorders that could lead to uncertain absorption of the study supplements (i.e., inflammatory bowel disease, ulcerative colitis, -Crohn's disease, colostomy, or eating disorder)
* History of kidney or liver disease
* History of metabolic disorders (diabetes, metabolic syndrome, other)
* History of current malignancy/cancer
* Receiving chemotherapy agents or radiation treatments
* Diagnosis of a terminal illness
* The investigator feels that, for any reason, the subject is not eligible to participate in the study
Primary outcome measure(s)
- Inflammaging (CIMKDM) — Time Frame: Baseline (Week 1) and Post-Intervention (Day 84 to 90)
A fasting venous blood sample will be collected via venipuncture by a certified phlebotomist at the participant's designated Labcorp location following a minimum 10-hour overnight fast. Samples will be processed at a central laboratory using standardized assay protocols. Inflammaging (CIMKDM) is a biologically derived estimate of age, expressed in years, calculated from a composite of inflammatory biomarkers reflecting chronic low-grade inflammation and immune system activation. Higher values indicate a greater degree of inflammation-related biological aging.
- Phenotypic Age — Time Frame: Baseline (Week 1) and Post-Intervention (Day 84 to 90)
A fasting venous blood sample will be collected via venipuncture by a certified phlebotomist at the participant's designated Labcorp location following a minimum 10-hour overnight fast. Samples will be processed at a central laboratory. Phenotypic Age is a composite biomarker-based estimate of biological aging, expressed in years, derived from chronological age and nine clinical chemistry and hematological markers (albumin, creatinine, glucose, C-reactive protein, lymphocyte percentage, mean cell volume, red cell distribution width, alkaline phosphatase, and white blood cell count). Higher values relative to chronological age indicate accelerated biological aging.
Trial sites (1)
| Facility | City | Region | Status |
| The Applied Science and Performance Institute |
Tampa |
Florida |
Recruiting |
More Applied Science & Performance Institute trials in the USA
Other trials for the same condition