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

NCT06040905 | Completed

• 1 other identifier: CS1-22182
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment; Alzheimer Disease; Hyperglycemia; Pre-sarcopenia

Outcome Measures

Primary Outcomes (6)

• Fasting glucose

  Fasting glucose will be measured by an automated chemistry analyzer.

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

• HbA1C

  HbA1C will be measured by an automated glycated hemoglobin analyzer.

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

• Insulin

  Insulin will be measured by chemiluminescence assay.

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

• C-peptide

  C-peptide will be measured by chemiluminescence assay.

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

• Brain-derived neurotrophic factor (BDNF)

  Serum BDNF levels will be measured using a human BDNF ELISA kit.

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

• Irisin

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

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

Secondary Outcomes (8)

• 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

Other Outcomes (6)

• ATP levels

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

• Citrate synthase activity

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

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

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

Study Arms (2)

Coenzyme Q10 followed by Placebo

EXPERIMENTAL

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.

Dietary Supplement: Coenzyme Q10; Other: Placebo

Placebo followed by Coenzyme Q10

EXPERIMENTAL

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.

Dietary Supplement: Coenzyme Q10; Other: Placebo

Interventions

Coenzyme Q10 DIETARY_SUPPLEMENT

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

Coenzyme Q10 followed by Placebo; Placebo followed by Coenzyme Q10

Placebo OTHER

Starch

Coenzyme Q10 followed by Placebo; Placebo followed by Coenzyme Q10

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chung Shan Medical University: lead
• National Science and Technology Council: collaborator

Study Sites (1)

Chung Shan Medical University Hospital

Taichung, Taiwan

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease; Hyperglycemia

Interventions

coenzyme Q10

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ping-Ting Lin, Ph.D.

  Chung Shan Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: September 18, 2023
• Study Start: January 24, 2024
• Primary Completion: February 12, 2026
• Study Completion: February 12, 2026
• Last Updated: August 21, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)