Fatigue Severity Scale, GLP - 1, Muscle Contraction, Obesity & Overweight, Ubiquinol
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTUbiquinol 100 MG Oral Capsule
The active intervention is a commercially available ubiquinol dietary supplement. The dose is one 100mg capsule per day taken.
DIETARY_SUPPLEMENTPlacebo
The 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.
Sponsors
StudySetGo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported fatigue | 9 months | Measured via Chalder Fatigue Scale score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life questionnaire | 9 months | Measured via WHOQoL-BREF |
| Skeletal muscle function | 9 months | Measured via 5 x sit-to-stand test |
| Body Mass | 9 months | Body Mass measured in kg |
| Blood pyruvate levels | 9 months | 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. |
| Blood Lactate levels | 9 months | 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. |
| Blood Coenzyme Q10 levels | 9 months | 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. |
| Blood Creatine Kinase levels | 9 months | 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. |
| Blood Vitamin D levels | 9 months | 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. |
| Blood Ferritin levels | 9 months | 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. |
| Blood Magnesium levels | 9 months | 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. |
| Blood Total Cholesterol levels | 9 months | 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. |
| Blood LDL levels | 9 months | 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. |
| Blood HDL levels | 9 months | 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. |
| Blood Triglycerides levels | 9 months | 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. |
| Blood Vitamin B12 levels | 9 months | 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. |
| Blood HBA1C levels | 9 months | 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. |
| Height | 9 months | Measured in metres |
| Body Mass Index | 9 months | Measured in kg/m² |
Countries
United Kingdom
Contacts
CONTACTTom Jameson, PhD
Outcome results
None listed