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.

The Effects of Sesame Extract on the Quality of Life and Antioxidative Status in Sleeping Disorder Patients

Sleeping Disorders

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.

sesame extract

placebo

PSQI is used to evaluate sleeping quality. A self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval.

ESS i a self-administered questionnaire, and is used to assess the 'daytime sleepiness' of the patients.

BDI-11 is a self-report questionnaire rating measurements characteristic attitudes and symptoms of depression.

BAI is a self-report questionnaire that is used for measuring the severity of anxiety.

SF-12 is a general health questionnaire, which evaluated quality of life.

BMI (kg/m^2), body composition and blood pressure (mmHg)

Serum BUN (mg/dL),Creatinine (mg/dL), eGFR (mL/min) and urine acid (mg/dL)

Serum HDL-C, LDL-C, triglyceride and total cholesterol (mg/dL)

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(%).

Concentration of thiobarbituric acid-reactive substance, glutathione/oxidized glutathione ratio

Concentration of serum sesamin and it's metabolite

Dietary supplement: sesame extract (contains sesamin 37-56mg per capsule)
This group will be given supplements for 8 weeks.

Placebo treatment ( identical capsules containing Lactose, Silica, Magnesium Stearate, Gelatin)

The Effects of Sesame Extract on the Quality of Life and Antioxidative Status in Sleeping Disorder Patients

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

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