Effects of Sesamin on Sleep Quality and Antioxidative Status

NCT ID: NCT05678439

Last Updated: 2024-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-18
• Study Completion Date: 2023-12-18

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.

Conditions

Sleeping Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

sesame extract

Dietary supplement: sesame extract (contains sesamin 37-56mg per capsule)

This group will be given supplements for 8 weeks.

Group Type: EXPERIMENTAL

sesame extract

Intervention Type: DIETARY_SUPPLEMENT

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

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

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

New Taipei City, , Taiwan

Taipei Medical University

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

N202205061

Identifier Type: -

Identifier Source: org_study_id