Causal Effect of Coenzyme Q10 Nutrition and Cognitive Dysfunction in the Metabolic Storm (Hyperglycemia and Sarcopenia) and Brain-derived Neurotrophic Factor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- HbA1C
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of mild cognitive impairment (MCI) or Alzheimer's disease (AD).
- •Hyperglycemia, defined as fasting plasma glucose ≥100 mg/dL or current use of glucose-lowering medication.
- •Either without sarcopenia risk or with pre-sarcopenia/sarcopenia risk, as determined by calf circumference, handgrip strength, or muscle endurance.
- •Ability to swallow tablets.
排除标准
- •Severe cardiac, pulmonary, hepatic, or renal disease.
- •Severe disability or aphasia.
- •Malnutrition (body weight change >5% within one month).
- •Current use of coenzyme Q10 supplements.
- •Current warfarin therapy.
研究组 & 干预措施
Coenzyme Q10 followed by Placebo
Participants received coenzyme Q10 300 mg/day (150 mg twice daily) for 12 weeks, followed by a 4-week washout period, and then placebo for 12 weeks.
干预措施: Placebo (Other)
Placebo followed by Coenzyme Q10
Participants received placebo for 12 weeks, followed by a 4-week washout period, and then coenzyme Q10 300 mg/day (150 mg twice daily) for 12 weeks.
干预措施: Placebo (Other)
Coenzyme Q10 followed by Placebo
Participants received coenzyme Q10 300 mg/day (150 mg twice daily) for 12 weeks, followed by a 4-week washout period, and then placebo for 12 weeks.
干预措施: Coenzyme Q10 (Dietary Supplement)
Placebo followed by Coenzyme Q10
Participants received placebo for 12 weeks, followed by a 4-week washout period, and then coenzyme Q10 300 mg/day (150 mg twice daily) for 12 weeks.
干预措施: Coenzyme Q10 (Dietary Supplement)
结局指标
主要结局
HbA1C
时间窗: 12 weeks
HbA1C will measured by an automated glycated hemoglobin analyzer.
Brain-derived neurotrophic factor (BDNF)
时间窗: 12 weeks
Sreum BDNF level will measured by huamn BDNF ELISA kit.
Fasting glucose
时间窗: 12 weeks
Fasting glucose will measured by an automated chemistry analyzer.
Insulin
时间窗: 12 weeks
Insulin will measured by chemiluminescence assay.
C-peptide
时间窗: 12 weeks
C-peptide will measured by chemiluminescence assay.
Irisin
时间窗: 12 weeks
Measured by huamn Irisin ELISA kit.
Myostatin
时间窗: 12 weeks
Measured by human myostatin ELISA kit.
Fasting glucose
时间窗: Baseline and at the end of each 12-week intervention period
Fasting glucose will be measured by an automated chemistry analyzer.
HbA1C
时间窗: Baseline and at the end of each 12-week intervention period
HbA1C will be measured by an automated glycated hemoglobin analyzer.
Insulin
时间窗: Baseline and at the end of each 12-week intervention period
Insulin will be measured by chemiluminescence assay.
C-peptide
时间窗: Baseline and at the end of each 12-week intervention period
C-peptide will be measured by chemiluminescence assay.
Brain-derived neurotrophic factor (BDNF)
时间窗: Baseline and at the end of each 12-week intervention period
Serum BDNF levels will be measured using a human BDNF ELISA kit.
Irisin
时间窗: Baseline and at the end of each 12-week intervention period
Irisin levels will be measured using a human irisin ELISA kit.
次要结局
- Malondialdehyde (MDA) level(12 weeks)
- Advanced Glycation End Products (AGEs) level(12 weeks)
- Total antioxidant capacity(12 weeks)
- Mini-Mental State Examination (MMSE) score(12 weeks)
- Muscle mass(12 weeks)
- Hand grip(12 weeks)
- Short Physical Performance Battery (SPPB) measurement(12 weeks)
- Advanced Glycation End Product (AGE) levels(Baseline and at the end of each 12-week intervention period)
- Total antioxidant capacity(Baseline and at the end of each 12-week intervention period)
- Mini-Mental State Examination (MMSE) score(Baseline and at the end of each 12-week intervention period)
- Muscle mass(Baseline and at the end of each 12-week intervention period)
- Handgrip strength(Baseline and at the end of each 12-week intervention period)
- Short Physical Performance Battery (SPPB) score(Baseline and at the end of each 12-week intervention period)
- Protein carbonyl levels(Baseline and at the end of each 12-week intervention period)
- Serotonin levels(Baseline and at the end of each 12-week intervention period)
研究者
Ping-Ting Lin
Professor
Chung Shan Medical University