Causal Effect of Coenzyme Q10 Nutrition and Cognitive Dysfunction in the Metabolic Storm (Hyperglycemia and Sarcopenia) and Brain-derived Neurotrophic Factor
Primary Purpose
Mild Cognitive Impairment, Alzheimer Disease, Hyperglycemia
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Coenzyme Q10
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Mild Cognitive Impairment
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Coenzyme Q10
Placebo
Arm Description
Coenzyme Q10 300 mg/day (150 mg/b.i.d.)
Placebo (dextrin)
Outcomes
Primary Outcome Measures
Fasting glucose
Fasting glucose will measured by an automated chemistry analyzer.
HbA1C
HbA1C will measured by an automated glycated hemoglobin analyzer.
Insulin
Insulin will measured by chemiluminescence assay.
C-peptide
C-peptide will measured by chemiluminescence assay.
Brain-derived neurotrophic factor (BDNF)
Sreum BDNF level will measured by huamn BDNF ELISA kit.
Irisin
Measured by huamn Irisin ELISA kit.
Myostatin
Measured by human myostatin ELISA kit.
Secondary Outcome Measures
Malondialdehyde (MDA) level
MDA will measured by thiobarbituric acid reacting substance.
Advanced Glycation End Products (AGEs) level
AGE level will measured by competitive enzyme-linked immunosorbent assay.
Total antioxidant capacity
Total antioxidant capacity will measured by a Trolox equivalent antioxidant capacity assay.
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.
Muscle mass
Muscle mass will measured by (Bioelectrical impedance analysis) BIA menchine.
Hand grip
Hand grip strength will be measured with a grip dynamometer.
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.
Full Information
NCT ID
NCT06040905
First Posted
September 4, 2023
Last Updated
September 10, 2023
Sponsor
Chung Shan Medical University
Collaborators
National Science and Technology Council
1. Study Identification
Unique Protocol Identification Number
NCT06040905
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
July 31, 2026 (Anticipated)
Study Completion Date
July 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chung Shan Medical University
Collaborators
National Science and Technology Council
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Alzheimer Disease, Hyperglycemia, Pre-sarcopenia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Coenzyme Q10
Arm Type
Experimental
Arm Description
Coenzyme Q10 300 mg/day (150 mg/b.i.d.)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (dextrin)
Intervention Type
Dietary Supplement
Intervention Name(s)
Coenzyme Q10
Intervention Description
300 mg/day (150mg/b.i.d)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Starch, dextrin
Primary Outcome Measure Information:
Title
Fasting glucose
Description
Fasting glucose will measured by an automated chemistry analyzer.
Time Frame
12 weeks
Title
HbA1C
Description
HbA1C will measured by an automated glycated hemoglobin analyzer.
Time Frame
12 weeks
Title
Insulin
Description
Insulin will measured by chemiluminescence assay.
Time Frame
12 weeks
Title
C-peptide
Description
C-peptide will measured by chemiluminescence assay.
Time Frame
12 weeks
Title
Brain-derived neurotrophic factor (BDNF)
Description
Sreum BDNF level will measured by huamn BDNF ELISA kit.
Time Frame
12 weeks
Title
Irisin
Description
Measured by huamn Irisin ELISA kit.
Time Frame
12 weeks
Title
Myostatin
Description
Measured by human myostatin ELISA kit.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Malondialdehyde (MDA) level
Description
MDA will measured by thiobarbituric acid reacting substance.
Time Frame
12 weeks
Title
Advanced Glycation End Products (AGEs) level
Description
AGE level will measured by competitive enzyme-linked immunosorbent assay.
Time Frame
12 weeks
Title
Total antioxidant capacity
Description
Total antioxidant capacity will measured by a Trolox equivalent antioxidant capacity assay.
Time Frame
12 weeks
Title
Mini-Mental State Examination (MMSE) score
Description
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.
Time Frame
12 weeks
Title
Muscle mass
Description
Muscle mass will measured by (Bioelectrical impedance analysis) BIA menchine.
Time Frame
12 weeks
Title
Hand grip
Description
Hand grip strength will be measured with a grip dynamometer.
Time Frame
12 weeks
Title
Short Physical Performance Battery (SPPB) measurement
Description
SPPB is an objective measurement instrument of balance, lower extremity strength, and functional capacity in older adults. A lower score means low physical fitness.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
ATP level
Description
ATP level will measured by ATP determination kit.
Time Frame
12 weeks
Title
Citrate synthase level
Description
Citrate synthase level will measured by Citrate Synthase Assay Kit.
Time Frame
12 weeks
Title
Quality of Life in Alzheimer's Disease Measure (QOL-AD)
Description
The QOL-AD score is the sum of all 13 items. Higher scores mean participants are more satisfied with their quality of life.
Time Frame
12 weeks
Title
Geriatric Depression Scale (GDS)
Description
The GDS score is the sum of all 15 items. Higher scores indicate a tendency for participants to feel depressed.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ping-Ting Lin, Ph.D.
Phone
+886-4-24730022
Ext
12187
Email
apt810@csmu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ping-Ting Lin, Ph.D.
Organizational Affiliation
Chung Shan Medical University
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
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Causal Effect of Coenzyme Q10 Nutrition and Cognitive Dysfunction in the Metabolic Storm (Hyperglycemia and Sarcopenia) and Brain-derived Neurotrophic Factor
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