The Effects of Quercefit® and Ubiqsome™ in Mitigating Inflammation and Promoting Metabolic Health

Applied Science & Performance Institute60 enrolled

Overview

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

This study will be a randomized, double-blind, placebo-controlled clinical study conducted over a 12-week intervention investigating the effects of Quercefit® (500 mg daily, 250 mg twice daily), Ubiqsome™ (300 mg daily, 150 mg twice daily), or a placebo (twice daily). Participants will be recruited nationally in a decentralized format and will complete testing procedures remotely, with blood draws conducted through partner labs and electronic survey assessments. Key biomarkers of inflammaging, phenotypic aging, biological age, glucose regulation, insulin sensitivity, insulin resistance, lipid profile, and cardiovascular health will be examined through repeated assessments as described below. This study will enroll 60 sedentary men and women, selected based on the inclusion and exclusion criteria defined in the protocol. Only individuals who meet all inclusion criteria and none of the exclusion criteria will be considered eligible. Recruitment will occur through an online participant database, through which applicants will be sent initial subject material. To begin enrollment, participants will complete screening to verify they are clinically overweight to obese (BMI ≥ 25.00 kg/m²), are sedentary men and women aged 50 to 75 years old, and are free of chronic cardiovascular, neurological, hepatic, renal, or metabolic disease, as determined by a health history questionnaire. As part of the screening process, participants will also be required to score 5 or higher on the CDC's prediabetes risk test (https://www.cdc.gov/prediabetes/takethetest). Finally, participants must not currently be using glucose-lowering agents or insulin. Upon passing all inclusion and exclusion criteria, participants will confirm their address and general availability. Before any study-related procedures are completed, participants will be asked to review and sign an informed consent form. Afterward, participants will be assigned a designated requisition form for blood collection at their preferred Labcorp location. During week one of testing, after a minimum 10-hour overnight fast from food, participants will arrive at the preferred Labcorp location confirmed during enrollment and complete a venipuncture-based blood draw for the collection of fasting biomarkers. This panel will include markers used to calculate composite inflammaging burden (CIMKDM), phenotypic age, metabolic health (glucose, insulin, HbA1c, HOMA-IR, QUICKI), lipid and cardiovascular risk factors, organ function (liver, kidney), inflammatory mediators (CRP, cortisol), and complete blood count with differential. Lab results will be emailed to research staff approximately 3 to 5 business days post-collection. On a separate day that same week, participants will complete physical and subjective testing remotely, including: (1) a grip strength assessment, conducted in triplicate on both hands using a digital hand dynamometer provided by the study team, and (2) completion of an electronic questionnaire including the Modified Fatigue Impact Scale (MFIS-21) and the Short Form-36 (SF-36) Health Survey. Instructions for standardized handgrip testing and survey completion will be provided electronically upon enrollment to the participant's email. Following completion of baseline assessments, participants will begin daily supplementation of their prescribed study materials with their assigned treatment group: Quercefit® (500 mg/day), Ubiqsome™ (300 mg/day), or placebo, taken as one capsule in the morning and one capsule in the evening, for a total of two capsules daily over 12 weeks. Participants will be instructed to maintain consistent dosing of the supplement with water and will log compliance and adverse events routinely. Check-ins will occur at baseline, week 12, and periodically in between to monitor adherence and assess for adverse events. On days 84 through 90 post-initial treatment, all baseline measures will be repeated following the same structure: a blood draw following an overnight fast, coordinated with the participant's preferred lab partner, followed that same week by remote grip strength testing and completion of the electronic questionnaires. Final adverse event assessments and compliance documentation will also be collected at this time. All procedures are designed to be completed remotely with direct coordination from study staff. Participants will be instructed to report any adverse events immediately and will receive regular contact throughout the study to support protocol adherence and data quality.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Inflammaging (CIMKDM)

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.