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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 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.

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chung Shan Medical University Hospital

Taichung, Taiwan

Location status: Recruiting

Location contact

Ping-Ting Lin, Ph.D.

CONTACT

[email protected]

+886-4-24730022 ext. 12187

About this study

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.

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).
  • Clinical diagnosis of Alzheimer's Disease.
  • MCI and AD patients with hyperglycemia ( Fasting glucose >=100 mg/dL).
  • MCI and AD patients with pre-sarcopenia (low calf circumference, low hand grip, or low muscle endurance).
  • Must be able to swallow tablets.

Exclusion criteria

  • Cancer patients.
  • Severe heart, lung, liver, and kidney diseases.
  • Severe disability or aphasia.
  • Malnutrition (body weight changes > 5% within one month).
  • Using coenzyme Q10 supplements.
  • Warfarin therapy.

Treatment and study plan

Coenzyme Q10

Dietary Supplement

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

Placebo

Other

Starch, dextrin

Primary outcomes

  1. Fasting glucose

    Time frame: 12 weeks

    Fasting glucose will measured by an automated chemistry analyzer.

  2. HbA1C

    Time frame: 12 weeks

    HbA1C will measured by an automated glycated hemoglobin analyzer.

  3. Insulin

    Time frame: 12 weeks

    Insulin will measured by chemiluminescence assay.

  4. C-peptide

    Time frame: 12 weeks

    C-peptide will measured by chemiluminescence assay.

  5. Brain-derived neurotrophic factor (BDNF)

    Time frame: 12 weeks

    Sreum BDNF level will measured by huamn BDNF ELISA kit.

  6. Irisin

    Time frame: 12 weeks

    Measured by huamn Irisin ELISA kit.

  7. Myostatin

    Time frame: 12 weeks

    Measured by human myostatin ELISA kit.

Secondary outcomes

  1. Malondialdehyde (MDA) level

    Time frame: 12 weeks

    MDA will measured by thiobarbituric acid reacting substance.

  2. Advanced Glycation End Products (AGEs) level

    Time frame: 12 weeks

    AGE level will measured by competitive enzyme-linked immunosorbent assay.

  3. Total antioxidant capacity

    Time frame: 12 weeks

    Total antioxidant capacity will measured by a Trolox equivalent antioxidant capacity assay.

  4. Mini-Mental State Examination (MMSE) score

    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.

  5. Muscle mass

    Time frame: 12 weeks

    Muscle mass will measured by (Bioelectrical impedance analysis) BIA menchine.

  6. Hand grip

    Time frame: 12 weeks

    Hand grip strength will be measured with a grip dynamometer.

  7. Short Physical Performance Battery (SPPB) measurement

    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.

Other outcomes

  1. ATP level

    Time frame: 12 weeks

    ATP level will measured by ATP determination kit.

  2. Citrate synthase level

    Time frame: 12 weeks

    Citrate synthase level will measured by Citrate Synthase Assay Kit.

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

    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.

  4. Geriatric Depression Scale (GDS)

    Time frame: 12 weeks

    The GDS score is the sum of all 15 items. Higher scores indicate a tendency for participants to feel depressed.

Study contacts

Contact information is provided by the study sponsor or research team.

Ping-Ting Lin, Ph.D.

CONTACT

[email protected]

+886-4-24730022 ext. 12187

Sponsors and collaborators

Lead sponsor

Chung Shan Medical University

Other

Collaborators

  • National Science and Technology Council

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 18, 2023
Registry last updated
Feb 7, 2024

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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