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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Sleeping Disorders

Intervention / Treatment
-----------------
* Dietary Supplement: sesame extract
* Other: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 20-80 years old Sleeping disorder patients with not or with low arousal threshold obstructive sleep apnea that were diagnosed by the doctor after PSG examination. Exclusion Criteria: Chronic diseases: liver, renal, gastrointestinal, cardiovascular diseases Cancer Pregnant Be allergy to the intervention materials or having supplements /drugs which might affect the study outcome.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sesame extract<br>Dietary supplement: sesame extract (contains sesamin 37-56mg per capsule) This group will be given supplements for 8 weeks. | Dietary Supplement: sesame extract<br>* 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.<br>|
| Placebo Comparator: placebo<br>Placebo treatment ( identical capsules containing Lactose, Silica, Magnesium Stearate, Gelatin) | Other: placebo<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline The Pittsburgh Sleep Quality Index (PSQI) at two months | PSQI is used to evaluate sleeping quality. A self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. | At the start of the experiment and at the 8th, 11th and 19th week | 
| Change from Baseline Epworth Sleepiness Scale (ESS) at two months | ESS i a self-administered questionnaire, and is used to assess the 'daytime sleepiness' of the patients. | At the start of the experiment and at the 8th, 11th and 19th week | 
| Change from Baseline Beck Depression Inventory-II (BDI-11) score at two months | BDI-11 is a self-report questionnaire rating measurements characteristic attitudes and symptoms of depression. | At the start of the experiment and at the 8th, 11th and 19th week | 
| Change from Baseline Beck Anxiety Inventory (BAI) score at two months | BAI is a self-report questionnaire that is used for measuring the severity of anxiety. | At the start of the experiment and at the 8th, 11th and 19th week | 
| Change from Baseline Short form-12 items health survey (SF-12) at two months | SF-12 is a general health questionnaire, which evaluated quality of life. | At the start of the experiment and at the 8th, 11th and 19th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anthropometric assessmrnt | BMI (kg/m^2), body composition and blood pressure (mmHg) | At the start of the experiment and at the 4th, 8th, 11th, 15th and 19th week | 
| Liver function | Serum AST and ALT (U/L) | At the start of the experiment and at the 8th, 11th and 19th week | 
| Kidney function | Serum BUN (mg/dL),Creatinine (mg/dL), eGFR (mL/min) and urine acid (mg/dL) | At the start of the experiment and at the 8th, 11th and 19th week | 
| Lipid profile | Serum HDL-C, LDL-C, triglyceride and total cholesterol (mg/dL) | At the start of the experiment and at the 8th, 11th and 19th week | 
| Hematology | 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(%). | At the start of the experiment and at the 8th, 11th and 19th week | 
| Antioxidative status | Concentration of thiobarbituric acid-reactive substance, glutathione/oxidized glutathione ratio | At the start of the experiment and at the 8th, 11th and 19th week | 
| Sesamin and it's metabolite | Concentration of serum sesamin and it's metabolite | At the start of the experiment and at the 8th, 11th and 19th week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sesamin, Sleeping Disorders, antioxidant