Office 1110 3 Fitzroy Place, 1/1, Sauchiehall Street
Glasgow, G3 7RH, United Kingdom
NCT Number: NCT07789106
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.
Trial opening soon.
Get Notified30 year–65 year
All sexes
Interventional
Not applicable
Glasgow, G3 7RH, United Kingdom
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The active intervention is a commercially available ubiquinol dietary supplement, manufactured and supplied by Kaneka (Japan). The dose is one 100mg capsule per day taken.
The placebo is manufactured by the same manufacturer that produces the active product (Kaneka, Japan). 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.
Time frame: 9 months
Measured via Chalder Fatigue Scale score
Time frame: 9 months
Measured via WHOQoL-BREF
Time frame: 9 months
Measured via 5 x sit-to-stand test
Time frame: 9 months
Body Mass measured in kg
Time frame: 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 Complement Genomics (Durham, UK) following their own standard operating procedures.
Time frame: 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 Complement Genomics (Durham, UK) following their own standard operating procedures.
Time frame: 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 Complement Genomics (Durham, UK) following their own standard operating procedures.
Time frame: 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 Complement Genomics (Durham, UK) following their own standard operating procedures.
Time frame: 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 Complement Genomics (Durham, UK) following their own standard operating procedures.
Time frame: 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 Complement Genomics (Durham, UK) following their own standard operating procedures.
Time frame: 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 Complement Genomics (Durham, UK) following their own standard operating procedures.
Time frame: 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 Complement Genomics (Durham, UK) following their own standard operating procedures.
Time frame: 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 Complement Genomics (Durham, UK) following their own standard operating procedures.
Time frame: 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 Complement Genomics (Durham, UK) following their own standard operating procedures.
Time frame: 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 Complement Genomics (Durham, UK) following their own standard operating procedures.
Time frame: 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 Complement Genomics (Durham, UK) following their own standard operating procedures.
Time frame: 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 Complement Genomics (Durham, UK) following their own standard operating procedures.
Time frame: 9 months
Measured in metres
Time frame: 9 months
Measured in kg/m²
Contact information is provided by the study sponsor or research team.
StudySetGo
Network
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")
Acronym: Project Zest
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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