Clinical trial NCT05678439: Effects of Sesamin on Sleep Quality and Antioxidative Status
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleeping Disorders
Keywords: Sleeping Disorders
sesamin
antioxidant
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2023-01-10
Enrollment: 33
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline The Pittsburgh Sleep Quality Index (PSQI) at two months
timeFrame: At the start of the experiment and at the 8th, 11th and 19th week
measure: Change from Baseline Epworth Sleepiness Scale (ESS) at two months
timeFrame: At the start of the experiment and at the 8th, 11th and 19th week
measure: Change from Baseline Beck Depression Inventory-II (BDI-11) score at two months
timeFrame: At the start of the experiment and at the 8th, 11th and 19th week
measure: Change from Baseline Beck Anxiety Inventory (BAI) score at two months
timeFrame: At the start of the experiment and at the 8th, 11th and 19th week
measure: Change from Baseline Short form-12 items health survey (SF-12) at two months
timeFrame: At the start of the experiment and at the 8th, 11th and 19th week
Secondary outcomes:
measure: Anthropometric assessmrnt
timeFrame: At the start of the experiment and at the 4th, 8th, 11th, 15th and 19th week
measure: Liver function
timeFrame: At the start of the experiment and at the 8th, 11th and 19th week
measure: Kidney function
timeFrame: At the start of the experiment and at the 8th, 11th and 19th week
measure: Lipid profile
timeFrame: At the start of the experiment and at the 8th, 11th and 19th week
measure: Hematology
timeFrame: At the start of the experiment and at the 8th, 11th and 19th week
measure: Antioxidative status
timeFrame: At the start of the experiment and at the 8th, 11th and 19th week
measure: Sesamin and it's metabolite
timeFrame: At the start of the experiment and at the 8th, 11th and 19th week
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
city: Taipei
country: Taiwan
facility: Taipei Medical University
Study officials:
References: