Chung Shan Medical University Hospital
Taichung, Taiwan
NCT Number: NCT06040905
The aim of the study is to investigate the effects of coenzyme Q10 supplementation (150 mg twice daily; 300 mg/day for 12 weeks) on coenzyme Q10 status, glucose parameters, BDNF, myokines, and cognitive function in patients with mild cognitive impairment (MCI) or Alzheimer's disease (AD) and hyperglycemia, either without sarcopenia risk or with pre-sarcopenia/sarcopenia risk.
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Notify Me50 year–80 year
All sexes
Interventional
Not applicable
Taichung, Taiwan
Mild cognitive impairment (MCI) and Alzheimer's disease (AD) are associated with impaired glucose and energy metabolism, oxidative stress, and nutritional imbalance. Coenzyme Q10 is an antioxidant nutrient involved in mitochondrial energy production and may have beneficial effects on glucose metabolism and muscle function. This randomized, double-blind, placebo-controlled crossover study investigated the effects of coenzyme Q10 supplementation in participants with MCI or AD and hyperglycemia, either without sarcopenia risk or with pre-sarcopenia/sarcopenia risk. Participants received coenzyme Q10 300 mg/day (150 mg twice daily) or placebo for 12 weeks, followed by a 4-week washout period and crossover to the alternate intervention for another 12 weeks. Anthropometric measurements, nutritional status, body composition, muscle function, cognitive function, quality of life, and depressive symptoms were assessed. Blood samples were collected to evaluate coenzyme Q10, glucose metabolism, BDNF, oxidative stress, antioxidant capacity, myokines, and mitochondrial function. The study aimed to evaluate the effects of coenzyme Q10 supplementation on glucose metabolism, muscle and physical function, and related metabolic and neurotrophic factors in participants with cognitive impairment and hyperglycemia.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
300 mg/day (150 mg/b.i.d)
Starch
Time frame: Baseline and at the end of each 12-week intervention period
Fasting glucose will be measured by an automated chemistry analyzer.
Time frame: Baseline and at the end of each 12-week intervention period
HbA1C will be measured by an automated glycated hemoglobin analyzer.
Time frame: Baseline and at the end of each 12-week intervention period
Insulin will be measured by chemiluminescence assay.
Time frame: Baseline and at the end of each 12-week intervention period
C-peptide will be measured by chemiluminescence assay.
Time frame: Baseline and at the end of each 12-week intervention period
Serum BDNF levels will be measured using a human BDNF ELISA kit.
Time frame: Baseline and at the end of each 12-week intervention period
Irisin levels will be measured using a human irisin ELISA kit.
Time frame: Baseline and at the end of each 12-week intervention period
AGE levels will be measured using a competitive enzyme-linked immunosorbent assay.
Time frame: Baseline and at the end of each 12-week intervention period
Total antioxidant capacity will be measured using a Trolox equivalent antioxidant capacity assay.
Time frame: Baseline and at the end of each 12-week intervention period
The MMSE score ranges from 0 to 30, with higher scores indicating better cognitive function.
Time frame: Baseline and at the end of each 12-week intervention period
Muscle mass will be measured using bioelectrical impedance analysis (BIA).
Time frame: Baseline and at the end of each 12-week intervention period
Hand grip strength will be measured with a grip dynamometer.
Time frame: Baseline and at the end of each 12-week intervention period
SPPB is an objective measurement instrument of balance, lower extremity strength, and functional capacity.
Time frame: Baseline and at the end of each 12-week intervention period
Protein carbonyl levels will be measured using a colorimetric assay kit.
Time frame: Baseline and at the end of each 12-week intervention period
Serotonin levels will be measured using an ELISA kit.
Time frame: Baseline and at the end of each 12-week intervention period
ATP levels will be measured using an ATP determination kit.
Time frame: Baseline and at the end of each 12-week intervention period
Citrate synthase activity will be measured using a citrate synthase assay kit.
Time frame: Baseline and at the end of each 12-week intervention period
The QOL-AD score is the sum of all 13 items. Higher scores mean participants are more satisfied with their quality of life.
Time frame: Baseline and at the end of each 12-week intervention period
The GDS score is the sum of all 15 items.
Time frame: Baseline and at the end of each 12-week intervention period
Plasma coenzyme Q10 concentration will be measured using high-performance liquid chromatography (HPLC).
Time frame: Baseline and at the end of each 12-week intervention period
Walking speed will be calculated from the 6-minute walk test and expressed in meters per second (m/s).
Chung Shan Medical University
Other
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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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