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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

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
Chung Shan Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Mild Cognitive Impairment

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

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

    First Posted
    September 4, 2023
    Last Updated
    September 10, 2023
    Sponsor
    Chung Shan Medical University
    Collaborators
    National Science and Technology Council
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    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

    Learn more about this trial

    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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