A Study on Ubiquinol on Fatigue and Muscle Strength in Healthy Adults Taking GLP-1 Agonists

A Randomised, Placebo-Controlled Trial to Evaluate the Effect of Ubiquinol on Fatigue and Muscle Strength in Healthy Adults Who Are Self-Administering GLP-1 Agonists ("Project Zest")

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.

Inclusion Criteria:

• 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
• Owns a smartphone (iOS 15.6 or later, Android 9 or later) and is willing and able to install the SANNO Health app
• Proficient in English language speaking and reading
• Owns their own digital body weighing scale
• Able and willing to provide full informed consent

Exclusion Criteria:

• 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
• Other medications, which in the opinion of the Chief Investigator, may deplete CoQ10
• Failed screening bloods (any results that is outside of the lab reference range)
• Intention to stop GLP-1 agonist use within 9 months of randomisation
• Pregnancy, breastfeeding or intention to conceive during study