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

Chung Shan Medical University

Status: Enrolling

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

Treatments: Dietary Supplement: Coenzyme Q10; Other: Placebo

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06040905

CS1-22182

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

100 participants in 2 patient groups, including a placebo group

Coenzyme Q10

Experimental group

Description:

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

Treatment:

Dietary Supplement: Coenzyme Q10

Placebo

Placebo Comparator group

Description:

Placebo (dextrin)

Treatment:

Other: Placebo