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Completed

NCT Number: NCT06040905

Causal Effect of Coenzyme Q10 Nutrition and Cognitive Dysfunction in the Metabolic Storm (Hyperglycemia and Sarcopenia) and Brain-derived Neurotrophic Factor

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Coenzyme Q10

Dietary Supplement

300 mg/day (150 mg/b.i.d)

Placebo

Other

Starch

Primary outcomes

  1. Fasting glucose

    Time frame: Baseline and at the end of each 12-week intervention period

    Fasting glucose will be measured by an automated chemistry analyzer.

  2. HbA1C

    Time frame: Baseline and at the end of each 12-week intervention period

    HbA1C will be measured by an automated glycated hemoglobin analyzer.

  3. Insulin

    Time frame: Baseline and at the end of each 12-week intervention period

    Insulin will be measured by chemiluminescence assay.

  4. C-peptide

    Time frame: Baseline and at the end of each 12-week intervention period

    C-peptide will be measured by chemiluminescence assay.

  5. Brain-derived neurotrophic factor (BDNF)

    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.

  6. Irisin

    Time frame: Baseline and at the end of each 12-week intervention period

    Irisin levels will be measured using a human irisin ELISA kit.

Secondary outcomes

  1. Advanced Glycation End Product (AGE) levels

    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.

  2. Total antioxidant capacity

    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.

  3. Mini-Mental State Examination (MMSE) score

    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.

  4. Muscle mass

    Time frame: Baseline and at the end of each 12-week intervention period

    Muscle mass will be measured using bioelectrical impedance analysis (BIA).

  5. Handgrip strength

    Time frame: Baseline and at the end of each 12-week intervention period

    Hand grip strength will be measured with a grip dynamometer.

  6. Short Physical Performance Battery (SPPB) score

    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.

  7. Protein carbonyl levels

    Time frame: Baseline and at the end of each 12-week intervention period

    Protein carbonyl levels will be measured using a colorimetric assay kit.

  8. Serotonin levels

    Time frame: Baseline and at the end of each 12-week intervention period

    Serotonin levels will be measured using an ELISA kit.

Other outcomes

  1. ATP levels

    Time frame: Baseline and at the end of each 12-week intervention period

    ATP levels will be measured using an ATP determination kit.

  2. Citrate synthase activity

    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.

  3. Quality of Life in Alzheimer's Disease Measure (QOL-AD)

    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.

  4. Geriatric Depression Scale (GDS)

    Time frame: Baseline and at the end of each 12-week intervention period

    The GDS score is the sum of all 15 items.

  5. Plasma coenzyme Q10 concentration

    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).

  6. 6-minute walking speed

    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).

Sponsors and collaborators

Lead sponsor

Chung Shan Medical University

Other

Collaborators

  • National Science and Technology Council

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 18, 2023
Registry last updated
Aug 21, 2026

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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