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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorChung Shan Medical University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

Cancer patients.

Severe heart, lung, liver, and kidney diseases.

Severe disability or aphasia.

Malnutrition (body weight changes > 5% within one month).

Trial design

Design model

Crossover

Treatments tested in this trial

  • Coenzyme Q10

    Dietary supplement

    300 mg/day (150mg/b.i.d)

  • Placebo

    Other intervention

    Starch, dextrin

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Coenzyme Q10Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Fasting glucose

Fasting glucose will measured by an automated chemistry analyzer.

Time frame
12 weeks
2

HbA1C

HbA1C will measured by an automated glycated hemoglobin analyzer.

Time frame
12 weeks
3

Insulin

Insulin will measured by chemiluminescence assay.

Time frame
12 weeks
4

C-peptide

C-peptide will measured by chemiluminescence assay.

Time frame
12 weeks

Secondary outcomes

1

Malondialdehyde (MDA) level

MDA will measured by thiobarbituric acid reacting substance.

Time frame
12 weeks
2

Advanced Glycation End Products (AGEs) level

AGE level will measured by competitive enzyme-linked immunosorbent assay.

Time frame
12 weeks
3

Total antioxidant capacity

Total antioxidant capacity will measured by a Trolox equivalent antioxidant capacity assay.

Time frame
12 weeks
4

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.

Time frame
12 weeks

Other outcomes

1

ATP level

ATP level will measured by ATP determination kit.

Time frame
12 weeks
2

Citrate synthase level

Citrate synthase level will measured by Citrate Synthase Assay Kit.

Time frame
12 weeks
3

Quality of Life in Alzheimer's Disease Measure (QOL-AD)

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
4

Geriatric Depression Scale (GDS)

The GDS score is the sum of all 15 items. Higher scores indicate a tendency for participants to feel depressed.

Time frame
12 weeks

Sponsors and contacts

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Chung Shan Medical University

Lead sponsor

National Science and Technology Council

Collaborator