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

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

Detailed Description

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 Criteria

Interventions