Chung Shan Medical University Hospital
Taichung, Taiwan
Location status: Recruiting
NCT Number: NCT06040905
The aim of the study is to investigate the effect of coenzyme Q10 supplementation (150 mg/b.i.d, 300 mg/d, 12 weeks) on coenzyme Q10, glucose parameters, BDNF, myokines, and cognitive function in mild cognitive impairment (MCI) and Alzheimer's disease (AD) patients who combined with hyperglycemia but without sarcopenia, or with hyperglycemia and pre-sarcopenia.
Interested in participating?
Request Info50 year–80 year
All sexes
Interventional
Not applicable
Taichung, Taiwan
Location status: Recruiting
Alzheimer's disease (AD) is an aging-related disease and is considered to be a type 3 diabetes. Brain-derived neurotrophic factor (BDNF) is a potential therapeutic biomarker for AD. Studies have found that antioxidant supplementation could elevate the level of BDNF. Coenzyme Q10 is an antioxidant nutrient that participates in energy synthesis in mitochondria. Studies have shown that coenzyme Q10 has the potential to regulate blood glucose. However, there are few clinical studies to examine the effects of coenzyme Q10 supplementation on glucose and muscular metabolism and BDNF status in AD. This study will conduct an intervention study to understand the effect of coenzyme Q10 on BDNF and metabolic conditions (hyperglycemia and pre-sarcopenia) in patients with mild cognitive impairment (MCI) and AD. The study will be designed as a randomized, double-blind, cross-over, placebo-controlled study. To investigate the effect of coenzyme Q10 supplementation (150 mg/b.i.d, 300 mg/d, 12 weeks) on coenzyme Q10, glucose parameters, BDNF, myokines, and cognitive function in MCI and AD patients who combined with hyperglycemia but without sarcopenia, or with hyperglycemia and pre-sarcopenia. During the study, demographic data, mini-mental state examination, anthropometric measurements, dietary records, nutritional and muscle function assessment, quality of life, and depression assessment will be collected. Blood specimens will be also collected before and after the intervention; then the levels of coenzyme Q10, BDNF, oxidative stress, antioxidant capacity, myokines, and mitochondrial function will be analyzed. The study hopes to clarify the cause effects of coenzyme Q10 supplementation on the regulation of glucose and muscle metabolism, and cognitive function in this prospective clinical study. The results of this study will provide a reference for aging nutrition and health care.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
300 mg/day (150mg/b.i.d)
Starch, dextrin
Time frame: 12 weeks
Fasting glucose will measured by an automated chemistry analyzer.
Time frame: 12 weeks
HbA1C will measured by an automated glycated hemoglobin analyzer.
Time frame: 12 weeks
Insulin will measured by chemiluminescence assay.
Time frame: 12 weeks
C-peptide will measured by chemiluminescence assay.
Time frame: 12 weeks
Sreum BDNF level will measured by huamn BDNF ELISA kit.
Time frame: 12 weeks
Measured by huamn Irisin ELISA kit.
Time frame: 12 weeks
Measured by human myostatin ELISA kit.
Time frame: 12 weeks
MDA will measured by thiobarbituric acid reacting substance.
Time frame: 12 weeks
AGE level will measured by competitive enzyme-linked immunosorbent assay.
Time frame: 12 weeks
Total antioxidant capacity will measured by a Trolox equivalent antioxidant capacity assay.
Time frame: 12 weeks
The maximum score for the MMSE is 30. A score of 25 or higher is classed as normal. If the score is below 24, the result is usually considered to be abnormal, indicating possible cognitive impairment.
Time frame: 12 weeks
Muscle mass will measured by (Bioelectrical impedance analysis) BIA menchine.
Time frame: 12 weeks
Hand grip strength will be measured with a grip dynamometer.
Time frame: 12 weeks
SPPB is an objective measurement instrument of balance, lower extremity strength, and functional capacity in older adults. A lower score means low physical fitness.
Time frame: 12 weeks
ATP level will measured by ATP determination kit.
Time frame: 12 weeks
Citrate synthase level will measured by Citrate Synthase Assay Kit.
Time frame: 12 weeks
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: 12 weeks
The GDS score is the sum of all 15 items. Higher scores indicate a tendency for participants to feel depressed.
Contact information is provided by the study sponsor or research team.
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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