A study to evaluate the effect of ETAZEO supplementation on sleep quality
| ISRCTN | ISRCTN60603080 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN60603080 |
| Secondary identifying numbers | SL/IL 22-0456 |
- Submission date
- 18/06/2024
- Registration date
- 27/06/2024
- Last edited
- 20/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English Summary
Background and study aims
The health impact of improved sleep and reduced snoring cannot be underestimated. Chronic sleeplessness and other related sleep disorders have been associated with an increased risk of developing various health conditions such as hypertension, coronary artery disease, and stroke. This scientific research study is designed to test the impact of ETAZEO®, a supplement containing fermented Salvia Officinalis (sage) metabolites, on sleep and snoring in Asian participants over 4 weeks.
Who can participate?
Healthy non-smoker Asian subjects aged between 25 and 65 years old (inclusive) with the presence of chronically disturbed sleep (PSQI >5)
What does the study involve?
Participants will be randomly assigned to a once-daily ETAZEO® supplement or a placebo/dummy supplement for 4 weeks.
What are the possible benefits and risks of participating:
Possible benefits are an improvement in skin health. No risks are expected.
Where is the study run from?
INNOVATION LABO Sciences Co., Ltd (Japan)
When is the study starting and how long is it expected to run for?
June 2023 to July 2023
Who is funding the study?
INNOVATION LABO Sciences Co., Ltd (Japan)
Who is the main contact?
Dr Yuki Ikeda, development@innovationlabo.com (Japan)
Contact information
Scientific
Shintomi HJ bldg 5F
1-12-7 Shintomi
Tokyo
104-0041
Japan
 ORCID ID |
0000-0001-6067-4574 |
|---|---|
| Phone | +81 335525335 |
| development@innovationlabo.com |
Principal Investigator
1 place marie Curie
Annecy
74000
France
| Phone | +33 (0)4 50 33 08 63 |
|---|---|
| innovation@mayor-invivo.com |
Public
Shintomi HJ bldg 5F
1-12-7 Shintomi
Tokyo
104-0041
Japan
| Phone | +81 335525335 |
|---|---|
| tokyo@innovationlabo.com |
Study information
| Study design | Interventional double-blind placebo-controlled single-center randomized clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Double-blind placebo-controlled clinical study to evaluate the effect of supplementation with ETAZEO during 4 weeks in improving sleep quality in healthy Asian adults suffering from insomnia |
| Study hypothesis | ETAZEO is more efficient than a placebo in improving sleep quality |
| Ethics approval(s) |
Approved 30/11/2022, Japanese Society of Anti-Aging Nutrition (JAAN) (Ginza, Chuo-ku, Tokyo, 104-0061, Japan; +81 3 3552 5277; coordinator@jaan.jp), ref: ILOS22633-K148 |
| Condition | Improvement of sleep quality in participants with insomnia |
| Intervention | This study investigates 4 weeks of daily supplementation with ETAZEO (250 mg capsule) or a placebo (dextrin, 250 mg capsule) taken orally in the evening before sleep. Block randomization was used to allocate participants to each group. Block randomization is used to divide potential patients into m blocks of size 2n, randomize each block such that n patients are allocated to A and n to B then choose the blocks randomly. This method ensures equal treatment allocation within each block if the complete block is used. |
| Intervention type | Supplement |
| Primary outcome measure | Change in sleep score measured using the Pittsburgh Sleep Quality Index (PSQI) questionnaire at baseline and week 4 |
| Secondary outcome measures | Change in snoring score measured using the Snoring Severity Scale (SSS) questionnaire at baseline and week 4 |
| Overall study start date | 12/05/2022 |
| Overall study end date | 31/07/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 25 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 40 |
| Total final enrolment | 40 |
| Participant inclusion criteria | 1. Healthy non-smoker Asian male and female subjects between 25-65 years old (inclusive) 2. Presence of chronic disturbed sleep (PSQI >5) 3. Presence of chronic snoring. A patient is considered a chronic snorer if his/her bedmate/roommate reported snoring more than 5 days per week and if this is corroborated by medical analysis performed in the patient’s own home. The result of the respiratory polygraphy should indicate the presence of snoring during at least 30% of the nocturnal period. 4. Have a regular roommate or bedmate to submit information 5. Subjects available during the whole period of study (1 month) |
| Participant exclusion criteria | 1. Subjects with sleep apnoea 2. High-risk professions and/or controlling dangerous machines 3. Moderate or severe somnolence during day time 4. Coronary cardiopathy, acute vascular disease (less than three months), chronic and severe obstructive pulmonary disease, and chronic treatment with theophyllines 5. Temporo-mandibular joint problems or periodontitis 6. Mandibular protrusion capacity less than 6 mm and/or less than 10 teeth in each jaw 7. Severe cognitive disorders and/or patients whose answers to the questionnaires will be altered by chronic and severe diseases 8. Pregnancy (since the third month of pregnancy to 3 months after birth delivery) 9. Patients on prolonged medication(more than 6 weeks) with sleep medication, corticosteroids, antidepressants, anticholinergics, antipsychotic drugs, etc. or any other drugs that may have an influence on the outcome of the study 10. Pregnant/lactating women 11. Subjects who cannot agree to refrain from alcohol consumption during the study period 12. Alcoholics and/or drug abusers 13. Subjects having history of psychiatric disorders that may impair the ability to provide written informed consent 14. Patients who have completed participation in any other clinical trials during the past 3 months 15. Any other conditions that the Principal Investigator thinks may jeopardize the study outcomes |
| Recruitment start date | 21/02/2023 |
| Recruitment end date | 13/04/2023 |
Locations
Countries of recruitment
- France
Study participating centre
Annecy
74000
France
Sponsor information
Industry
Shintomi HJ bldg 5F, 1-12-7 Shintomi
Tokyo
104-0041 Chuo-ku
Japan
| Phone | +81 (0)3-35525335 |
|---|---|
| technologies@innovationlabo.com | |
| Website | https://www.innovationlabo.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Yuki Ikeda, development@innovationlabo.com. Anonymised IPD will be available upon publication of results and for a period of 2 years. Consent from participants was required and obtained. |
Editorial Notes
18/06/2024: Study's existence confirmed by the Japanese Society of Anti-Aging Nutrition (JAAN).
