Sleeping Disorders
Conditions
Keywords
Sleeping Disorders, sesamin, antioxidant
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.
Interventions
DIETARY_SUPPLEMENTsesame extract
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.
OTHERplacebo
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.
Sponsors
Taipei Medical University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 20-80 years old 2. Sleeping disorder patients with not or with low arousal threshold obstructive sleep apnea that were diagnosed by the doctor after PSG examination.
Exclusion criteria
1. Chronic diseases: liver, renal, gastrointestinal, cardiovascular diseases 2. Cancer 3. Pregnant 4. Be allergy to the intervention materials or having supplements /drugs which might affect the study outcome.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline The Pittsburgh Sleep Quality Index (PSQI) at two months | 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. |
| Change from Baseline Epworth Sleepiness Scale (ESS) at two months | 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. |
| Change from Baseline Beck Depression Inventory-II (BDI-11) score at two months | 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. |
| Change from Baseline Beck Anxiety Inventory (BAI) score at two months | 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. |
| Change from Baseline Short form-12 items health survey (SF-12) at two months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antioxidative status | At the start of the experiment and at the 8th, 11th and 19th week | Concentration of thiobarbituric acid-reactive substance, glutathione/oxidized glutathione ratio |
| Anthropometric assessmrnt | 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) |
| Sesamin and it's metabolite | At the start of the experiment and at the 8th, 11th and 19th week | Concentration of serum sesamin and it's metabolite |
| Liver function | At the start of the experiment and at the 8th, 11th and 19th week | Serum AST and ALT (U/L) |
| Kidney function | 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) |
| Lipid profile | 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) |
| Hematology | 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(%). |
Countries
Taiwan
Outcome results
None listed