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.

Study Overview

• Status: Completed
• Conditions: Hyperglycemia; Alzheimer Disease; Mild Cognitive Impairment; Pre-sarcopenia
• Intervention / Treatment: Other: Placebo; Dietary supplement: Coenzyme Q10

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.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan
    • Chung Shan Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Placebo; Starch; Dietary supplement: Coenzyme Q10; 300 mg/day (150 mg/b.i.d)
Experimental: 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.	Other: Placebo; Starch; Dietary supplement: Coenzyme Q10; 300 mg/day (150 mg/b.i.d)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Advanced Glycation End Product (AGE) levels	AGE levels will be measured using a competitive enzyme-linked immunosorbent assay.	Baseline and at the end of each 12-week intervention period
Total antioxidant capacity	Total antioxidant capacity will be measured using a Trolox equivalent antioxidant capacity assay.	Baseline and at the end of each 12-week intervention period
Mini-Mental State Examination (MMSE) score	The MMSE score ranges from 0 to 30, with higher scores indicating better cognitive function.	Baseline and at the end of each 12-week intervention period
Muscle mass	Muscle mass will be measured using bioelectrical impedance analysis (BIA).	Baseline and at the end of each 12-week intervention period
Handgrip strength	Hand grip strength will be measured with a grip dynamometer.	Baseline and at the end of each 12-week intervention period
Short Physical Performance Battery (SPPB) score	SPPB is an objective measurement instrument of balance, lower extremity strength, and functional capacity.	Baseline and at the end of each 12-week intervention period
Protein carbonyl levels	Protein carbonyl levels will be measured using a colorimetric assay kit.	Baseline and at the end of each 12-week intervention period
Serotonin levels	Serotonin levels will be measured using an ELISA kit.	Baseline and at the end of each 12-week intervention period

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
ATP levels	ATP levels will be measured using an ATP determination kit.	Baseline and at the end of each 12-week intervention period
Citrate synthase activity	Citrate synthase activity will be measured using a citrate synthase assay kit.	Baseline and at the end of each 12-week intervention period
Quality of Life in Alzheimer's Disease Measure (QOL-AD)	The QOL-AD score is the sum of all 13 items. Higher scores mean participants are more satisfied with their quality of life.	Baseline and at the end of each 12-week intervention period
Geriatric Depression Scale (GDS)	The GDS score is the sum of all 15 items.	Baseline and at the end of each 12-week intervention period
Plasma coenzyme Q10 concentration	Plasma coenzyme Q10 concentration will be measured using high-performance liquid chromatography (HPLC).	Baseline and at the end of each 12-week intervention period
6-minute walking speed	Walking speed will be calculated from the 6-minute walk test and expressed in meters per second (m/s).	Baseline and at the end of each 12-week intervention period

Collaborators and Investigators

• Sponsor: Chung Shan Medical University
• Collaborators: National Science and Technology Council
• Investigators: Study Director: Ping-Ting Lin, Ph.D., Chung Shan Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2024
• Primary Completion (Actual): February 12, 2026
• Study Completion (Actual): February 12, 2026

Study Registration Dates

• First Submitted: September 4, 2023
• First Submitted That Met QC Criteria: September 10, 2023
• First Posted (Actual): September 18, 2023

Study Record Updates

• Last Update Posted (Actual): August 21, 2026
• Last Update Submitted That Met QC Criteria: August 19, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Metabolic Diseases; Neurocognitive Disorders; Glucose Metabolism Disorders; Cognition Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Nutritional and Metabolic Diseases; Cognitive Dysfunction; Alzheimer Disease; Hyperglycemia; Physiological Effects of Drugs; Micronutrients; Vitamins; coenzyme Q10
• Other Study ID Numbers: CS1-22182

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No