Effects of Sesamin on Sleep Quality and Antioxidative Status

NCT05678439 | Completed

• 1 other identifier: N202205061
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

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.

Conditions

Sleeping Disorders

Keywords

Sleeping Disorders; sesamin; antioxidant

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (7)

• Anthropometric assessmrnt

  At the start of the experiment and at the 4th, 8th, 11th, 15th and 19th week

• Liver function

  At the start of the experiment and at the 8th, 11th and 19th week

• Kidney function

  At the start of the experiment and at the 8th, 11th and 19th week

• Lipid profile

  At the start of the experiment and at the 8th, 11th and 19th week

• Hematology

  At the start of the experiment and at the 8th, 11th and 19th week

Study Arms (2)

sesame extract

EXPERIMENTAL

Dietary supplement: sesame extract (contains sesamin 37-56mg per capsule) This group will be given supplements for 8 weeks.

Dietary Supplement: sesame extract

placebo

PLACEBO COMPARATOR

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

Other: placebo

Interventions

sesame extract 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.

sesame extract

placebo 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.

placebo

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (2)

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

New Taipei City, 235, Taiwan

Location

Taipei Medical University

Taipei, 110, Taiwan

Location

MeSH Terms

Conditions

Parasomnias

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2022
• First Posted: January 10, 2023
• Study Start: November 18, 2022
• Primary Completion: December 18, 2023
• Study Completion: December 18, 2023
• Last Updated: May 23, 2024

Record last verified: 2023-10

Locations

TW (2)