Tokyo, March 28 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061086) titled 'Research on the effects of fermentable dietary fiber intake and behavioral intervention on sleep and stress' on March 27.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Single blind -investigator(s) and assessor(s) are blinded
Control - No treatment
Primary Sponsor:
Institute - Healthcare Systems Co., Ltd.
Condition:
Condition - Healthy Adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To exploratorily evaluate the effects of 4-week combined use of fermentable dietary fiber-containing food and behavioral intervention (meditation) on changes in sleep quality, stress levels, and the intestinal environment among healthy adult men and women aged 20 to 49.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Daily consumption of one bottle of fermentable dietary fiber-containing food (a total of 24 bottles) over the 4-week intervention period.
Perform meditation once daily before bedtime as much as possible for 4 weeks.
Interventions/Control_2 - none
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - 1.Persons who received a sufficient explanation of the purpose and contents of the study, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2.Japanese aged 20 to 49 years at the time of providing informed consent
3.Persons who have concerns regarding sleep and stress
Key exclusion criteria - 1.Persons with chronic illnesses receiving medical treatment or having a serious medical history.
2.Persons diagnosed with sleep disorders by a physician, such as sleep apnea syndrome or insomnia.
3.Persons with a history of or current treatment for psychiatric disorders, such as depression or anxiety disorders.
4.Persons taking psychotropic medications, including hypnotics, anxiolytics, or antidepressants.
5.Persons with severe chronic diseases, such as hypertension, diabetes, liver disease, or kidney disease.
6.Persons likely to develop seasonal allergic symptoms that may significantly affect sleep during the study period.
7.Persons whose sleep is disturbed by painful conditions, such as neuralgia or arthritis.
8.Persons working shifts or frequently traveling abroad with significant time zone changes.
9.Persons with a habit of excessive alcohol consumption.
10.Persons with a habit of excessive caffeine intake.
11.Persons with a smoking habit who may be affected by the arousal effects of nicotine.
12.Persons with a habit of strenuous exercise that may significantly affect sleep due to physical fatigue.
13.Persons who regularly practice meditation or have strict sleep habits that are difficult to modify.
14.Persons regularly using medications or health foods that may affect sleep, stress, or immunity.
15.Persons regularly using medications, health foods, or prebiotic or probiotic products that may affect defecation or the intestinal environment.
16.Persons with allergies to the test food.
17.Persons who habitually and actively consume dietary fiber.
18.Persons who have recently experienced or are likely to experience significant mental stress due to life events.
19.Persons with recent (within 1 month) or planned participation in other research.
20.Persons judged ineligible by the principal investigator.
21.Persons who are pregnant, breastfeeding, or planning pregnancy.
Target Size - 70
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 03 Month 27 Day
Anticipated trial start date - 2026 Year 04 Month 20 Day
Last follow-up date - 2026 Year 06 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069896
Disclaimer: Curated by HT Syndication.
