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.

Study Overview

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

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ping-Ting Lin, Ph.D.; Phone Number: 12187 +886-4-24730022; Email: apt810@csmu.edu.tw

Study Locations

• Taiwan
  • Taichung, Taiwan
    • Recruiting
    • Chung Shan Medical University Hospital
    • Contact: Ping-Ting Lin, Ph.D.; Phone Number: 12187 +886-4-24730022; Email: apt810@csmu.edu.tw

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).
• 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.

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; Coenzyme Q10 300 mg/day (150 mg/b.i.d.)	Dietary supplement: Coenzyme Q10; 300 mg/day (150mg/b.i.d)
Placebo Comparator: Placebo; Placebo (dextrin)	Other: Placebo; Starch, dextrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting glucose	Fasting glucose will measured by an automated chemistry analyzer.	12 weeks
HbA1C	HbA1C will measured by an automated glycated hemoglobin analyzer.	12 weeks
Insulin	Insulin will measured by chemiluminescence assay.	12 weeks
C-peptide	C-peptide will measured by chemiluminescence assay.	12 weeks
Brain-derived neurotrophic factor (BDNF)	Sreum BDNF level will measured by huamn BDNF ELISA kit.	12 weeks
Irisin	Measured by huamn Irisin ELISA kit.	12 weeks
Myostatin	Measured by human myostatin ELISA kit.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Malondialdehyde (MDA) level	MDA will measured by thiobarbituric acid reacting substance.	12 weeks
Advanced Glycation End Products (AGEs) level	AGE level will measured by competitive enzyme-linked immunosorbent assay.	12 weeks
Total antioxidant capacity	Total antioxidant capacity will measured by a Trolox equivalent antioxidant capacity assay.	12 weeks
Mini-Mental State Examination (MMSE) score	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.	12 weeks
Muscle mass	Muscle mass will measured by (Bioelectrical impedance analysis) BIA menchine.	12 weeks
Hand grip	Hand grip strength will be measured with a grip dynamometer.	12 weeks
Short Physical Performance Battery (SPPB) measurement	SPPB is an objective measurement instrument of balance, lower extremity strength, and functional capacity in older adults. A lower score means low physical fitness.	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
ATP level	ATP level will measured by ATP determination kit.	12 weeks
Citrate synthase level	Citrate synthase level will measured by Citrate Synthase Assay Kit.	12 weeks
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.	12 weeks
Geriatric Depression Scale (GDS)	The GDS score is the sum of all 15 items. Higher scores indicate a tendency for participants to feel depressed.	12 weeks

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): December 26, 2023
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 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 (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurocognitive Disorders; Neurodegenerative Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Dementia; Tauopathies; Cognition Disorders; Muscular Atrophy; Atrophy; Hyperglycemia; Alzheimer Disease; Cognitive Dysfunction; Sarcopenia; Physiological Effects of Drugs; Micronutrients; Vitamins; Coenzyme Q10; Ubiquinone
• 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