Effects of Sesamin on Sleep Quality and Antioxidative Status

Taipei Medical University

Status: Completed

Conditions: Sleeping Disorders

Treatments: Other: placebo; Dietary Supplement: sesame extract

Study type: Interventional

Funder types: Other

Identifiers

NCT05678439

N202205061

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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33 participants in 2 patient groups, including a placebo group

sesame extract

Experimental group

Description:

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

Treatment:

Dietary Supplement: sesame extract

placebo

Placebo Comparator group

Description:

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

Treatment:

Other: placebo