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

Last updated: February 5, 2024
Sponsor: Chung Shan Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Mellitus Types I And Ii

Memory Loss

Sarcopenia

Treatment

Placebo

Coenzyme Q10

Clinical Study ID

NCT06040905
CS1-22182
  • Ages 50-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 lowmuscle endurance).
  • Must be able to swallow tablets.

Exclusion

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 Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Placebo
Phase:
Study Start date:
December 26, 2023
Estimated Completion Date:
July 31, 2026

Study 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.

Connect with a study center

  • Chung Shan Medical University Hospital

    Taichung,
    Taiwan

    Active - Recruiting

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