NCT Number: NCT05678439
Sesame recognized as a common healthy food. Sesamin is extracted from sesame and has high antioxidant capacity which is commonly added in functional foods. Present studies had found sesamin supplementation could improve self-reported fatigue but more evidence should be clarify. The purpose of this study is to evaluate the effects of sesame extract on the quality of life and antioxidative status on sleeping disorder patients with not or with low arousal threshold obstructive sleep apnea and assess the potential product development.
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Notify Me20 year–80 year
All sexes
Interventional
Not applicable
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare, New Taipei City, Taiwan
30-50 subjects aged from 20 to 80 years old without sleep apnea or with low arousal threshold obstructive sleep apnea will be enrolled in this randomized, double-blind, cross-over, and placebo-controlled 8-week period experiment.
At the treatment period (0th to 8th week of the experiment), subjects will receive 2 placebo or capsules of sesame complex (37-56mg sesamin per capsule). The 9th to 11th week will be the washout period. The control and sesamin group will be cross-over at 11th week to 12th week of the experiment. Sleep quality, life quality examination and anti-oxidative functions will be carried out in this study. The basic anthropometric examination will be carried out at the beginning, 4th, 8th, 11th, 15th, and 19th week of the study. Routine laboratory parameters including liver function, kidney function, blood sugar, lipid profile, and anti-oxidative status will be investigated at the beginning, 8th, 11th and 19th week of the study. The questionnaire evaluation including the Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale, Beck Depression Inventory-II, Beck Anxiety Inventory, and Short form-12 items health survey will be investigated at the beginning, 8th, 11th, and 19th week of the study. We expect that sesame complex including 37-56mg sesamin may improve oxidative status which in turn ameliorates the sleep quality, life quality, and anti-oxidative functions in patients with sleep disorder.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
At the treatment period (0th to 8th week of the experiment), participants with sleeping disorder will receive 2 capsules of sesame extract (sesamin 37-56mg per capsule). The 8th to 9th week will be the washout period. The placebo group and sesame extract group will be cross-over at 10th week to 18th week of the experiment.
At the treatment period (0th to 8th week of the experiment), participants with sleeping disorder will receive 2 capsules of placebo. The 8th to 9th week will be the washout period. The placebo group and sesame extract group will be cross-over at 10th week to 18th week of the experiment.
Time frame: At the start of the experiment and at the 8th, 11th and 19th week
PSQI is used to evaluate sleeping quality. A self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval.
Time frame: At the start of the experiment and at the 8th, 11th and 19th week
ESS i a self-administered questionnaire, and is used to assess the 'daytime sleepiness' of the patients.
Time frame: At the start of the experiment and at the 8th, 11th and 19th week
BDI-11 is a self-report questionnaire rating measurements characteristic attitudes and symptoms of depression.
Time frame: At the start of the experiment and at the 8th, 11th and 19th week
BAI is a self-report questionnaire that is used for measuring the severity of anxiety.
Time frame: At the start of the experiment and at the 8th, 11th and 19th week
SF-12 is a general health questionnaire, which evaluated quality of life.
Time frame: At the start of the experiment and at the 4th, 8th, 11th, 15th and 19th week
BMI (kg/m^2), body composition and blood pressure (mmHg)
Time frame: At the start of the experiment and at the 8th, 11th and 19th week
Serum AST and ALT (U/L)
Time frame: At the start of the experiment and at the 8th, 11th and 19th week
Serum BUN (mg/dL),Creatinine (mg/dL), eGFR (mL/min) and urine acid (mg/dL)
Time frame: At the start of the experiment and at the 8th, 11th and 19th week
Serum HDL-C, LDL-C, triglyceride and total cholesterol (mg/dL)
Time frame: At the start of the experiment and at the 8th, 11th and 19th week
WBC (10^3/uL), RBC (10^6/uL), hemoglobin (g/dL), hematocrit (%), MCV(fL), MCH (pg), MCHC (g/dL), platelet (10^3/uL), neutrophils (%), lymphocytes (%), monocytes (%), eosinophils (%) and basophils(%).
Time frame: At the start of the experiment and at the 8th, 11th and 19th week
Concentration of thiobarbituric acid-reactive substance, glutathione/oxidized glutathione ratio
Time frame: At the start of the experiment and at the 8th, 11th and 19th week
Concentration of serum sesamin and it's metabolite
Taipei Medical University
Other
Effects of Sesamin on Sleep Quality and Antioxidative Status in Low Arousal Threshold Obstructive Sleep Apnea Syndrome Patients and Patients With Risk of Obstructive Sleep Apnea Syndrome
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