Alzheimer Disease, Hyperglycemia, Mild Cognitive Impairment, Pre-sarcopenia
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTCoenzyme Q10
300 mg/day (150 mg/b.i.d)
OTHERPlacebo
Starch
Sponsors
Chung Shan Medical University
National Science and Technology Council
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Cancer. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fasting glucose | Baseline and at the end of each 12-week intervention period | Fasting glucose will be measured by an automated chemistry analyzer. |
| HbA1C | Baseline and at the end of each 12-week intervention period | HbA1C will be measured by an automated glycated hemoglobin analyzer. |
| Insulin | Baseline and at the end of each 12-week intervention period | Insulin will be measured by chemiluminescence assay. |
| C-peptide | Baseline and at the end of each 12-week intervention period | C-peptide will be measured by chemiluminescence assay. |
| Brain-derived neurotrophic factor (BDNF) | Baseline and at the end of each 12-week intervention period | Serum BDNF levels will be measured using a human BDNF ELISA kit. |
| Irisin | Baseline and at the end of each 12-week intervention period | Irisin levels will be measured using a human irisin ELISA kit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Advanced Glycation End Product (AGE) levels | Baseline and at the end of each 12-week intervention period | AGE levels will be measured using a competitive enzyme-linked immunosorbent assay. |
| Total antioxidant capacity | Baseline and at the end of each 12-week intervention period | Total antioxidant capacity will be measured using a Trolox equivalent antioxidant capacity assay. |
| Mini-Mental State Examination (MMSE) score | 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. |
| Muscle mass | Baseline and at the end of each 12-week intervention period | Muscle mass will be measured using bioelectrical impedance analysis (BIA). |
| Handgrip strength | Baseline and at the end of each 12-week intervention period | Hand grip strength will be measured with a grip dynamometer. |
| Short Physical Performance Battery (SPPB) score | 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. |
| Protein carbonyl levels | Baseline and at the end of each 12-week intervention period | Protein carbonyl levels will be measured using a colorimetric assay kit. |
| Serotonin levels | Baseline and at the end of each 12-week intervention period | Serotonin levels will be measured using an ELISA kit. |
Countries
Taiwan
Contacts
STUDY_DIRECTORPing-Ting Lin, Ph.D.
Chung Shan Medical University
Outcome results
None listed