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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06040905
• Other study ID #: CS1-22182
• Status: Recruiting
• Phase: N/A
• Start date: December 26, 2023
• Est. completion date: July 31, 2026

Study information

• Verified date: February 2024
• Source: Chung Shan Medical University
• Contact: Ping-Ting Lin, Ph.D.
• Phone: +886-4-24730022
• Email: apt810[@]csmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 31, 2026
• Est. primary completion date: July 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Hyperglycemia
• Mild Cognitive Impairment
• Sarcopenia

Intervention

Dietary Supplement:
• Coenzyme Q10
300 mg/day (150mg/b.i.d)

Other:
• Placebo
Starch, dextrin

Locations

Country	Name	City	State
Taiwan	Chung Shan Medical University Hospital	Taichung

Sponsors (2)

Lead Sponsor	Collaborator
Chung Shan Medical University	National Science and Technology Council

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	ATP level	ATP level will measured by ATP determination kit.	12 weeks
Other	Citrate synthase level	Citrate synthase level will measured by Citrate Synthase Assay Kit.	12 weeks
Other	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
Other	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
Primary	Fasting glucose	Fasting glucose will measured by an automated chemistry analyzer.	12 weeks
Primary	HbA1C	HbA1C will measured by an automated glycated hemoglobin analyzer.	12 weeks
Primary	Insulin	Insulin will measured by chemiluminescence assay.	12 weeks
Primary	C-peptide	C-peptide will measured by chemiluminescence assay.	12 weeks
Primary	Brain-derived neurotrophic factor (BDNF)	Sreum BDNF level will measured by huamn BDNF ELISA kit.	12 weeks
Primary	Irisin	Measured by huamn Irisin ELISA kit.	12 weeks
Primary	Myostatin	Measured by human myostatin ELISA kit.	12 weeks
Secondary	Malondialdehyde (MDA) level	MDA will measured by thiobarbituric acid reacting substance.	12 weeks
Secondary	Advanced Glycation End Products (AGEs) level	AGE level will measured by competitive enzyme-linked immunosorbent assay.	12 weeks
Secondary	Total antioxidant capacity	Total antioxidant capacity will measured by a Trolox equivalent antioxidant capacity assay.	12 weeks
Secondary	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
Secondary	Muscle mass	Muscle mass will measured by (Bioelectrical impedance analysis) BIA menchine.	12 weeks
Secondary	Hand grip	Hand grip strength will be measured with a grip dynamometer.	12 weeks
Secondary	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