The Effects of Quercefit® and Ubiqsome™ in Mitigating Inflammation and Promoting Metabolic Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-75
SponsorApplied Science & Performance Institute
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Quercetin (dietary supplement)
Dietary supplementNatural compound found in foods like apples and onions that may help reduce inflammation and support overall health.
Coenzyme Q10
Dietary supplementSubstance made by the body that helps produce energy in cells and also acts as an antioxidant to support heart and overall health.
Rice Flour
Dietary supplementAn inert carbohydrate used as the control treatment
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Group 1 (Quercefit® only)Experimental treatment 1 intervention
Group B: Group 2 (Ubiqsome™ only)Active comparator 1 intervention
Group C: Group 3 (Placebo)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Time Frame: Baseline (Week 1) and Post-Intervention (Day 84 to 90)2
Phenotypic Age
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.
Time frame
Time Frame: Baseline (Week 1) and Post-Intervention (Day 84 to 90)Secondary outcomes
1
Grip Strength
Handgrip strength will be assessed remotely using a digital hand dynamometer provided by the study team. Participants will perform three maximal isometric contractions on each hand, following standardized instructions for hand positioning and testing technique provided electronically at enrollment. The highest recorded value, in kilograms of force, will be used for analysis. This assessment serves as a practical indicator of overall muscle function and physical health.
Time frame
Time Frame: Baseline (Week 1) and Post-Intervention (Day 84 to 90)2
Insulin Resistance (HOMA-IR)
Calculated from fasting glucose and fasting insulin values obtained via venipuncture blood draw at a Labcorp location following a minimum 10-hour overnight fast, using the standard HOMA-IR formula. Higher scores indicate greater insulin resistance.
Time frame
Time Frame: Baseline (Week 1) and Post-Intervention (Day 84 to 90)3
Insulin Sensitivity (QUICKI)
Calculated from fasting glucose and fasting insulin values obtained via venipuncture blood draw at a Labcorp location following a minimum 10-hour overnight fast, using the standard QUICKI formula. Values typically range from approximately 0.3 to 0.4; higher values indicate better insulin sensitivity.
Time frame
Time Frame: Baseline (Week 1) and Post-Intervention (Day 84 to 90)4
High-Sensitivity C-Reactive Protein (hs-CRP)
Measured from a fasting venous blood sample collected via venipuncture at a Labcorp location and processed at a central laboratory. hs-CRP is a marker of systemic inflammation, reported in mg/L. Higher values indicate greater inflammation.
Time frame
Time Frame: Baseline (Week 1) and Post-Intervention (Day 84 to 90)Sponsors and contacts
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Source ClinicalTrials.gov