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

NCT ID: NCT06040905

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-26
• Study Completion Date: 2026-07-31

Brief Summary

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Coenzyme Q10

Coenzyme Q10 300 mg/day (150 mg/b.i.d.)

Group Type: EXPERIMENTAL

Coenzyme Q10

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

Placebo (dextrin)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Starch, dextrin

Interventions

Coenzyme Q10

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Starch, dextrin

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Science and Technology Council

FED

Sponsor Role: collaborator

Chung Shan Medical University

OTHER

Sponsor Role: lead

Responsible Party

Ping-Ting Lin

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ping-Ting Lin, Ph.D.

Role: STUDY_DIRECTOR

Chung Shan Medical University

Locations

Chung Shan Medical University Hospital

Taichung, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Ping-Ting Lin, Ph.D.

Role: CONTACT

apt810@csmu.edu.tw

+886-4-24730022 ext. 12187

Facility Contacts

Ping-Ting Lin, Ph.D.

Role: primary

apt810@csmu.edu.tw

+886-4-24730022 ext. 12187

Other Identifiers

CS1-22182

Identifier Type: -

Identifier Source: org_study_id