xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06040905</url>
    </required_header>
    <id_info>
      <org_study_id>CS1-22182</org_study_id>
      <nct_id>NCT06040905</nct_id>
    </id_info>
    <brief_title>Causal Effect of Coenzyme Q10 Nutrition and Cognitive Dysfunction in the Metabolic Storm (Hyperglycemia and Sarcopenia) and Brain-derived Neurotrophic Factor</brief_title>
    <official_title>Causal Effect of Coenzyme Q10 Nutrition and Cognitive Dysfunction in the Metabolic Storm (Hyperglycemia and Sarcopenia) and Brain-derived Neurotrophic Factor</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Chung Shan Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Science and Technology Council</agency>
        <agency_class>U.S. Fed</agency_class>
      </collaborator>
    </sponsors>
    <source>Chung Shan Medical University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of the study is to investigate the effect of coenzyme Q10 supplementation (150&#xD;
        mg/b.i.d, 300 mg/d, 12 weeks) on coenzyme Q10, glucose parameters, BDNF, myokines, and&#xD;
        cognitive function in mild cognitive impairment (MCI) and Alzheimer's disease (AD) patients&#xD;
        who combined with hyperglycemia but without sarcopenia, or with hyperglycemia and&#xD;
        pre-sarcopenia.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Alzheimer's disease (AD) is an aging-related disease and is considered to be a type 3&#xD;
        diabetes. Brain-derived neurotrophic factor (BDNF) is a potential therapeutic biomarker for&#xD;
        AD. Studies have found that antioxidant supplementation could elevate the level of BDNF.&#xD;
        Coenzyme Q10 is an antioxidant nutrient that participates in energy synthesis in&#xD;
        mitochondria. Studies have shown that coenzyme Q10 has the potential to regulate blood&#xD;
        glucose. However, there are few clinical studies to examine the effects of coenzyme Q10&#xD;
        supplementation on glucose and muscular metabolism and BDNF status in AD. This study will&#xD;
        conduct an intervention study to understand the effect of coenzyme Q10 on BDNF and metabolic&#xD;
        conditions (hyperglycemia and pre-sarcopenia) in patients with mild cognitive impairment&#xD;
        (MCI) and AD. The study will be designed as a randomized, double-blind, cross-over,&#xD;
        placebo-controlled study. To investigate the effect of coenzyme Q10 supplementation (150&#xD;
        mg/b.i.d, 300 mg/d, 12 weeks) on coenzyme Q10, glucose parameters, BDNF, myokines, and&#xD;
        cognitive function in MCI and AD patients who combined with hyperglycemia but without&#xD;
        sarcopenia, or with hyperglycemia and pre-sarcopenia. During the study, demographic data,&#xD;
        mini-mental state examination, anthropometric measurements, dietary records, nutritional and&#xD;
        muscle function assessment, quality of life, and depression assessment will be collected.&#xD;
        Blood specimens will be also collected before and after the intervention; then the levels of&#xD;
        coenzyme Q10, BDNF, oxidative stress, antioxidant capacity, myokines, and mitochondrial&#xD;
        function will be analyzed. The study hopes to clarify the cause effects of coenzyme Q10&#xD;
        supplementation on the regulation of glucose and muscle metabolism, and cognitive function in&#xD;
        this prospective clinical study. The results of this study will provide a reference for aging&#xD;
        nutrition and health care.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>Double (Participant, Care Provider)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Fasting glucose</measure>
      <time_frame>12 weeks</time_frame>
      <description>Fasting glucose will measured by an automated chemistry analyzer.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>HbA1C</measure>
      <time_frame>12 weeks</time_frame>
      <description>HbA1C will measured by an automated glycated hemoglobin analyzer.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Insulin</measure>
      <time_frame>12 weeks</time_frame>
      <description>Insulin will measured by chemiluminescence assay.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>C-peptide</measure>
      <time_frame>12 weeks</time_frame>
      <description>C-peptide will measured by chemiluminescence assay.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Brain-derived neurotrophic factor (BDNF)</measure>
      <time_frame>12 weeks</time_frame>
      <description>Sreum BDNF level will measured by huamn BDNF ELISA kit.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Irisin</measure>
      <time_frame>12 weeks</time_frame>
      <description>Measured by huamn Irisin ELISA kit.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Myostatin</measure>
      <time_frame>12 weeks</time_frame>
      <description>Measured by human myostatin ELISA kit.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Malondialdehyde (MDA) level</measure>
      <time_frame>12 weeks</time_frame>
      <description>MDA will measured by thiobarbituric acid reacting substance.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Advanced Glycation End Products (AGEs) level</measure>
      <time_frame>12 weeks</time_frame>
      <description>AGE level will measured by competitive enzyme-linked immunosorbent assay.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total antioxidant capacity</measure>
      <time_frame>12 weeks</time_frame>
      <description>Total antioxidant capacity will measured by a Trolox equivalent antioxidant capacity assay.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mini-Mental State Examination (MMSE) score</measure>
      <time_frame>12 weeks</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Muscle mass</measure>
      <time_frame>12 weeks</time_frame>
      <description>Muscle mass will measured by (Bioelectrical impedance analysis) BIA menchine.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hand grip</measure>
      <time_frame>12 weeks</time_frame>
      <description>Hand grip strength will be measured with a grip dynamometer.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Short Physical Performance Battery (SPPB) measurement</measure>
      <time_frame>12 weeks</time_frame>
      <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.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>ATP level</measure>
      <time_frame>12 weeks</time_frame>
      <description>ATP level will measured by ATP determination kit.</description>
    </other_outcome>
    <other_outcome>
      <measure>Citrate synthase level</measure>
      <time_frame>12 weeks</time_frame>
      <description>Citrate synthase level will measured by Citrate Synthase Assay Kit.</description>
    </other_outcome>
    <other_outcome>
      <measure>Quality of Life in Alzheimer's Disease Measure (QOL-AD)</measure>
      <time_frame>12 weeks</time_frame>
      <description>The QOL-AD score is the sum of all 13 items. Higher scores mean participants are more satisfied with their quality of life.</description>
    </other_outcome>
    <other_outcome>
      <measure>Geriatric Depression Scale (GDS)</measure>
      <time_frame>12 weeks</time_frame>
      <description>The GDS score is the sum of all 15 items. Higher scores indicate a tendency for participants to feel depressed.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Mild Cognitive Impairment</condition>
    <condition>Alzheimer Disease</condition>
    <condition>Hyperglycemia</condition>
    <condition>Pre-sarcopenia</condition>
    <arm_group>
      <arm_group_label>Coenzyme Q10</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Coenzyme Q10 300 mg/day (150 mg/b.i.d.)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Placebo (dextrin)</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Coenzyme Q10</intervention_name>
      <description>300 mg/day (150mg/b.i.d)</description>
      <arm_group_label>Coenzyme Q10</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Starch, dextrin</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Clinical diagnosis of mild cognitive impairment (MCI).&#xD;
  &#xD;
            -  Clinical diagnosis of Alzheimer's Disease.&#xD;
  &#xD;
            -  MCI and AD patients with hyperglycemia ( Fasting glucose &gt;=100 mg/dL).&#xD;
  &#xD;
            -  MCI and AD patients with pre-sarcopenia (low calf circumference, low hand grip, or low&#xD;
               muscle endurance).&#xD;
  &#xD;
            -  Must be able to swallow tablets.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Cancer patients.&#xD;
  &#xD;
            -  Severe heart, lung, liver, and kidney diseases.&#xD;
  &#xD;
            -  Severe disability or aphasia.&#xD;
  &#xD;
            -  Malnutrition (body weight changes &gt; 5% within one month).&#xD;
  &#xD;
            -  Using coenzyme Q10 supplements.&#xD;
  &#xD;
            -  Warfarin therapy.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ping-Ting Lin, Ph.D.</last_name>
      <role>Study Director</role>
      <affiliation>Chung Shan Medical University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ping-Ting Lin, Ph.D.</last_name>
      <phone>+886-4-24730022</phone>
      <phone_ext>12187</phone_ext>
      <email>apt810@csmu.edu.tw</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 10, 2023</last_update_submitted>
    <last_update_submitted_qc>September 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Chung Shan Medical University</investigator_affiliation>
      <investigator_full_name>Ping-Ting Lin</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Alzheimer Disease</mesh_term>
      <mesh_term>Sarcopenia</mesh_term>
      <mesh_term>Hyperglycemia</mesh_term>
      <mesh_term>Cognitive Dysfunction</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Ubiquinone</mesh_term>
      <mesh_term>Coenzyme Q10</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06040905
  org study id: CS1-22182
  nct id: NCT06040905
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Basic Science
  masking: Double (Participant, Care Provider)
  measure: Fasting glucose
  time frame: 12 weeks
  description: Fasting glucose will measured by an automated chemistry analyzer.
  measure: HbA1C
  time frame: 12 weeks
  description: HbA1C will measured by an automated glycated hemoglobin analyzer.
  measure: Insulin
  time frame: 12 weeks
  description: Insulin will measured by chemiluminescence assay.
  measure: C-peptide
  time frame: 12 weeks
  description: C-peptide will measured by chemiluminescence assay.
  measure: Brain-derived neurotrophic factor (BDNF)
  time frame: 12 weeks
  description: Sreum BDNF level will measured by huamn BDNF ELISA kit.
  measure: Irisin
  time frame: 12 weeks
  description: Measured by huamn Irisin ELISA kit.
  measure: Myostatin
  time frame: 12 weeks
  description: Measured by human myostatin ELISA kit.
  measure: Malondialdehyde (MDA) level
  time frame: 12 weeks
  description: MDA will measured by thiobarbituric acid reacting substance.
  measure: Advanced Glycation End Products (AGEs) level
  time frame: 12 weeks
  description: AGE level will measured by competitive enzyme-linked immunosorbent assay.
  measure: Total antioxidant capacity
  time frame: 12 weeks
  description: Total antioxidant capacity will measured by a Trolox equivalent antioxidant capacity assay.
  measure: Mini-Mental State Examination (MMSE) score
  time frame: 12 weeks
  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.
  measure: Muscle mass
  time frame: 12 weeks
  description: Muscle mass will measured by (Bioelectrical impedance analysis) BIA menchine.
  measure: Hand grip
  time frame: 12 weeks
  description: Hand grip strength will be measured with a grip dynamometer.
  measure: Short Physical Performance Battery (SPPB) measurement
  time frame: 12 weeks
  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.
  measure: ATP level
  time frame: 12 weeks
  description: ATP level will measured by ATP determination kit.
  measure: Citrate synthase level
  time frame: 12 weeks
  description: Citrate synthase level will measured by Citrate Synthase Assay Kit.
  measure: Quality of Life in Alzheimer's Disease Measure (QOL-AD)
  time frame: 12 weeks
  description: The QOL-AD score is the sum of all 13 items. Higher scores mean participants are more satisfied with their quality of life.
  measure: Geriatric Depression Scale (GDS)
  time frame: 12 weeks
  description: The GDS score is the sum of all 15 items. Higher scores indicate a tendency for participants to feel depressed.
  arm group label: Coenzyme Q10
  arm group type: Experimental
  description: Coenzyme Q10 300 mg/day (150 mg/b.i.d.)
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Placebo (dextrin)
  intervention type: Dietary Supplement
  intervention name: Coenzyme Q10
  description: 300 mg/day (150mg/b.i.d)
  arm group label: Coenzyme Q10
  intervention type: Other
  intervention name: Placebo
  description: Starch, dextrin
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Ping-Ting Lin, Ph.D.
  role: Study Director
  affiliation: Chung Shan Medical University
  last name: Ping-Ting Lin, Ph.D.
  phone: +886-4-24730022
  phone ext: 12187
  email: apt810@csmu.edu.tw
  responsible party type: Principal Investigator
  investigator affiliation: Chung Shan Medical University
  investigator full name: Ping-Ting Lin
  investigator title: Professor
  mesh term: Alzheimer Disease
  mesh term: Sarcopenia
  mesh term: Hyperglycemia
  mesh term: Cognitive Dysfunction
  mesh term: Ubiquinone
  mesh term: Coenzyme Q10
  sharing ipd: No