Clinical trial NCT06040905: Causal Effect of Coenzyme Q10 Nutrition and Cognitive Dysfunction in the Metabolic Storm (Hyperglycemia and Sarcopenia) and Brain-derived Neurotrophic Factor
Official title: Causal Effect of Coenzyme Q10 Nutrition and Cognitive Dysfunction in the Metabolic Storm (Hyperglycemia and Sarcopenia) and Brain-derived Neurotrophic Factor
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Alzheimer Disease
Hyperglycemia
Pre-sarcopenia
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council
First posted: 2023-09-18
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Fasting glucose
timeFrame: 12 weeks
measure: HbA1C
timeFrame: 12 weeks
measure: Insulin
timeFrame: 12 weeks
measure: C-peptide
timeFrame: 12 weeks
measure: Brain-derived neurotrophic factor (BDNF)
timeFrame: 12 weeks
measure: Irisin
timeFrame: 12 weeks
measure: Myostatin
timeFrame: 12 weeks
Secondary outcomes:
measure: Malondialdehyde (MDA) level
timeFrame: 12 weeks
measure: Advanced Glycation End Products (AGEs) level
timeFrame: 12 weeks
measure: Total antioxidant capacity
timeFrame: 12 weeks
measure: Mini-Mental State Examination (MMSE) score
timeFrame: 12 weeks
measure: Muscle mass
timeFrame: 12 weeks
measure: Hand grip
timeFrame: 12 weeks
measure: Short Physical Performance Battery (SPPB) measurement
timeFrame: 12 weeks
Other outcomes:
measure: ATP level
timeFrame: 12 weeks
measure: Citrate synthase level
timeFrame: 12 weeks
measure: Quality of Life in Alzheimer's Disease Measure (QOL-AD)
timeFrame: 12 weeks
measure: Geriatric Depression Scale (GDS)
timeFrame: 12 weeks
Locations:
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
Study officials:
affiliation: Chung Shan Medical University
name: Ping-Ting Lin, Ph.D.
role: STUDY_DIRECTOR
References: