Tokyo, Oct. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059396) titled 'A Study on the Effects of Continuous Intake of the Test Food on Alleviating Social Isolation and Loneliness' on Oct. 15.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Macromill, Inc.
Condition:
Condition - Healthy participants
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate the effects of 4-week continuous intake of the test food on alleviation of social isolation and loneliness, as well as on perceived social health, in healthy participants experiencing social isolation and loneliness through a randomized, double-blind, placebo-controlled, parallel-group study.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - 4-week intake of test foods
Interventions/Control_2 - 4-week intake of placebo foods
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - 1. Individuals aged between 20 and 64 years at the time of obtaining informed consent.
2. Healthy Japanese men and women.
3. Individuals who feel socially isolated and/or lonely.
4. Individuals who have the capacity to consent, have received sufficient explanation regarding the purpose and content of the study, have fully understood the information, and voluntarily agreed to participate by providing written informed consent.
Key exclusion criteria - 1. Individuals receiving medical treatment for psychiatric disorders or autonomic nervous system disorders, or those scheduled to receive such treatment or medication during the study period.
2. Individuals with chronic diseases who are receiving medical treatment.
3. Individuals with a serious past history of cerebrovascular, cardiac, hepatic, renal, hematological, or endocrine diseases.
4. Individuals with a serious past history of gastrointestinal diseases.
5. Individuals judged by the principal investigator to have a psychiatric disorder based on the score of SDS.
6. Individuals with a history of feeling unwell or experiencing health deterioration due to blood collection.
7. Individuals who may develop an allergic reaction to the test food.
8. Men or women who donated 200 mL of blood within 4 weeks or component blood within 2 weeks prior to the on-site screening test; women who donated 400 mL of blood within 16 weeks prior to the screening; or men who donated 400 mL of blood within 12 weeks prior to the screening.
9. Smokers.
10. Habitual alcohol consumers.
11. Individuals with extremely irregular sleep patterns or dietary habits.
12. Individuals who cannot discontinue the intake of Foods for Specified Health Uses (FOSHU), Foods with Function Claims, or other health foods during the study period.
13. Individuals who are expected to experience major changes in living environment, or significant changes in dietary or exercise habits during the study period.
14. Women who are breastfeeding, pregnant, possibly pregnant, or planning to become pregnant during the study period.
15. Individuals currently participating in another clinical trial, those who have participated in another clinical trial within 4 weeks prior to the on-site screening test, or those planning to participate in another clinical trial during the study period.
16. Any other individuals judged by the principal investigator to be inappropriate as study participants.
Target Size - 48
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 10 Month 08 Day
Date of IRB - 2025 Year 10 Month 08 Day
Anticipated trial start date - 2025 Year 10 Month 18 Day
Last follow-up date - 2025 Year 12 Month 15 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067792
Disclaimer: Curated by HT Syndication.
