A Study on Ubiquinol on Fatigue and Muscle Strength in Healthy Adults Taking GLP-1 Agonists
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-65
SponsorStudySetGo
About this trial
The goal of this clinical trial is to learn if a daily ubiquinol supplement can reduce fatigue and help maintain muscle strength in adults aged 30-65 who are taking a GLP-1 weight loss medication (Wegovy® or Mounjaro®). Ubiquinol is a form of Coenzyme Q10 (CoQ10), a substance the body makes naturally that plays a key role in energy production. The main questions it aims to answer are:
Does ubiquinol lower fatigue levels compared to a placebo (a look-alike capsule that contains no ubiquinol)? Does ubiquinol help maintain muscle strength during weight loss treatment?
Researchers will compare ubiquinol to a placebo to see if ubiquinol helps with fatigue and muscle strength in people using GLP-1 medications.
Participants will:
Take one ubiquinol (100 mg) or placebo capsule every day for 9 months Have a nurse visit their home 4 times (at months 0, 3, 6, and 9) to take a small blood sample, measure their body, and supervise a simple sit-to-stand exercise test. Attend a short monthly video call (about 20-30 minutes) with a study dietitian. Complete questionnaires and 4 days of diet logging every 3 months using a smartphone app. Log all exercise sessions in the smartphone app throughout the study.
This is a fully remote study - participants do not need to visit a clinic. About 90 people will take part.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 30-65 years
Body mass index >27kg/m2 and <35 kg/m2
Currently initiating, or has initiated within the preceding 4 weeks of screening, one of the following MHRA-licensed weight management pharmacotherapies: semaglutide 2.4mg (Wegovy®) or tirzepatide (Mounjaro®) prescribed for the indication of weight management.
Is physically mobile and able to complete 5x sit to stand movements
Disqualifiers
Prior use of ubiquinol or Co-enzyme Q10 within 3 months of screening
Diagnosed condition which, in the opinion of the Chief investigator, may independently impact fatigue (e.g. type 1 or type 2 diabetes, cardiovascular disease, obstructive sleep apnoea, inflammatory or autoimmune conditions, cirrhotic or advanced liver disease, malignancy)
Prior or current use of statin medication
Has previously used GLP-1 agonists and/or undergone bariatric surgery
Trial design
Design model
Parallel
Treatments tested in this trial
Ubiquinol 100 MG Oral Capsule
Dietary supplementThe active intervention is a commercially available ubiquinol dietary supplement. The dose is one 100mg capsule per day taken.
Placebo
Dietary supplementThe placebo is manufactured by the same manufacturer that produces the active product. The placebo is visually similar to the active product and will be packaged in the same bottles as the active intervention to maintain the blind. The dose is one 100mg capsule per day taken with the first meal of the day. The product is stored at room temperature.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: UbiquinolExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Self-reported fatigue
Measured via Chalder Fatigue Scale score
Time frame
9 monthsSecondary outcomes
1
Quality of life questionnaire
Measured via WHOQoL-BREF
Time frame
9 months2
Skeletal muscle function
Measured via 5 x sit-to-stand test
Time frame
9 months3
Body Mass
Body Mass measured in kg
Time frame
9 months4
Blood pyruvate levels
At each sampling timepoint, approximately 8 mL of blood will be drawn from the antecubital vein. Blood sampling, processing and analysis is managed by a third party company, following their own standard operating procedures.
Time frame
9 months Source ClinicalTrials.gov