NCT06040905

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Chung Shan Medical University · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Coenzyme Q10	300 mg/day (150mg/b.i.d)
OTHER	Placebo	Starch, dextrin

Timeline

• Start date: 2023-12-26
• Primary completion: 2026-07-31
• Completion: 2026-07-31
• First posted: 2023-09-18
• Last updated: 2024-02-07

Locations

1 site across 1 country: Taiwan