Sleeping DisordersNCT05678439
Effects of Sesamin on Sleep Quality and Antioxidative Status
A study testing sesame extract in people with Sleeping Disorders, run by Taipei Medical University at 2 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Sleeping Disorders
- What is being tested?
- sesame extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 2 sitesTaiwan
- Study dates
- 18 Nov 2022to 18 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
New Taipei City, 235
Taipei Medical University
Taipei, 110
About this study
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
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.
Read the 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
- Being tested
- sesame extract, placebo
- Keywords
- Sleeping Disorders, sesamin, antioxidant
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sesame extractDietary 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.
placeboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| sesame extract | Experimental | Dietary supplement: sesame extract (contains sesamin 37-56mg per capsule)
This group will be given supplements for 8 weeks. Receives: Dietary Supplement: sesame extract |
| placebo | Placebo comparator | Placebo treatment ( identical capsules containing Lactose, Silica, Magnesium Stearate, Gelatin) Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At the start of the experiment and at the 8th, 11th and 19th week
Secondary outcomes (7)
Anthropometric assessmrnt
BMI (kg/m^2), body composition and blood pressure (mmHg)
Measured: At the start of the experiment and at the 4th, 8th, 11th, 15th and 19th week
Liver function
Serum AST and ALT (U/L)
Measured: 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)
Measured: 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)
Measured: 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(%).
Measured: 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
Measured: 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
Measured: At the start of the experiment and at the 8th, 11th and 19th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start18 Nov 2022
- Primary completion18 Dec 2023
- Study completion18 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleeping DisordersStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05678439
- Sponsor's protocol ID
- N202205061
- Status last verified
- Oct 2023
- First submitted
- 2 Oct 2022
- Last updated
- 23 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05678439
- Acronym / sponsor ID
- N202205061
- Conditions
- Sleeping Disorders
- Keywords
- Sleeping Disorders, sesamin, antioxidant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 18 Nov 2022 (actual)
- Primary completion
- 18 Dec 2023 (actual)
- Study completion
- 18 Dec 2023 (actual)
- First posted
- 10 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sesame extract | Experimental | Dietary Supplement: sesame extractDietary supplement: sesame extract (contains sesamin 37-56mg per capsule) This group will be given supplements for 8 weeks. |
| placebo | Placebo comparator | Other: placeboPlacebo treatment ( identical capsules containing Lactose, Silica, Magnesium Stearate, Gelatin) |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sesame extractAt 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. | Dietary supplement | sesame extract |
| placeboAt 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. | Other | placebo |
Primary outcome
Change from Baseline The Pittsburgh Sleep Quality Index (PSQI) at two months
Time frame: At the start of the experiment and at the 8th, 11th and 19th week
PSQI is used to evaluate sleeping quality. A self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval.
Change from Baseline Epworth Sleepiness Scale (ESS) at two months
Time frame: At the start of the experiment and at the 8th, 11th and 19th week
ESS i a self-administered questionnaire, and is used to assess the 'daytime sleepiness' of the patients.
Change from Baseline Beck Depression Inventory-II (BDI-11) score at two months
Time frame: At the start of the experiment and at the 8th, 11th and 19th week
BDI-11 is a self-report questionnaire rating measurements characteristic attitudes and symptoms of depression.
Change from Baseline Beck Anxiety Inventory (BAI) score at two months
Time frame: At the start of the experiment and at the 8th, 11th and 19th week
BAI is a self-report questionnaire that is used for measuring the severity of anxiety.
Change from Baseline Short form-12 items health survey (SF-12) at two months
Time frame: At the start of the experiment and at the 8th, 11th and 19th week
SF-12 is a general health questionnaire, which evaluated quality of life.
7 secondary outcomes
Anthropometric assessmrnt
Time frame: At the start of the experiment and at the 4th, 8th, 11th, 15th and 19th week
Liver function
Time frame: At the start of the experiment and at the 8th, 11th and 19th week
Kidney function
Time frame: At the start of the experiment and at the 8th, 11th and 19th week
Lipid profile
Time frame: At the start of the experiment and at the 8th, 11th and 19th week
Hematology
Time frame: At the start of the experiment and at the 8th, 11th and 19th week
Antioxidative status
Time frame: At the start of the experiment and at the 8th, 11th and 19th week
Sesamin and it's metabolite
Time frame: At the start of the experiment and at the 8th, 11th and 19th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sesame extract in people with Sleeping Disorders, run by Taipei Medical University at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline The Pittsburgh Sleep Quality Index (PSQI) at two months (time frame: At the start of the experiment and at the 8th, 11th and 19th week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2024.