Effects of Sesamin on Sleep Quality and Antioxidative Status

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

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.

Study Overview

• Status: Completed
• Conditions: Sleeping Disorders
• Intervention / Treatment: Dietary supplement: sesame extract; Other: placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • New Taipei City, Taiwan, 235
    • Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
  • Taipei, Taiwan, 110
    • Taipei Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Taipei Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2022
• Primary Completion (Actual): December 18, 2023
• Study Completion (Actual): December 18, 2023

Study Registration Dates

• First Submitted: October 2, 2022
• First Submitted That Met QC Criteria: January 4, 2023
• First Posted (Actual): January 10, 2023

Study Record Updates

• Last Update Posted (Actual): May 23, 2024
• Last Update Submitted That Met QC Criteria: May 22, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: antioxidant; Sleeping Disorders; sesamin
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Wake Disorders; Parasomnias
• Other Study ID Numbers: N202205061

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No