Tokyo, Oct. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063131) titled 'A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effects of Lactobacillus Fermentation Products Intake on Maintenance of Physical Condition' on Oct. 1.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - IMEQRD Co., Ltd.
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To examine the effects of continuous intake of the test food for 8 weeks on maintenance of physical condition and immune function.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Participants will consume one packet of the test food daily for 8 weeks.
Interventions/Control_2 - Participants will consume one packet of the placebo food daily for 8 weeks.
Eligibility:
Age-lower limit - 35
years-old
=
Gender - Male and Female
Key inclusion criteria - 1. Healthy individuals aged 35-65 at consent
2. Japanese men and women
3. BMI between 18.5 and 30.0 kg/m^2
4. Prone to catching colds
5. Go out at least once a week for work or social activities, with opportunities for contact with others
6. Experience fatigue in daily life
7. Able to enter electronic diaries via smartphone or PC
8. Fully informed about the study, capable of consent, and voluntarily agree in writing
Key exclusion criteria - 1. Currently receiving treatment for any disease with medication or Kampo (as needed use permitted)
2. Under physician-supervised dietary or exercise therapy
3. Have atopic dermatitis, allergic rhinitis (seasonal or perennial), bronchial asthma, chronic bronchitis, or other immune-related diseases
4. Diagnosed with dry mouth or Sjogren's syndrome, or aware of low salivary secretion
5. History or presence of serious diseases
6. Regularly consume lactic acid bacteria-containing foods, specified health foods, nutritional supplements, or functional foods claiming immune benefits (>=3 days/week) for over a month before screening; those consuming =40g pure alcohol/day)
8. Unable to abstain from alcohol from the day before each visit
9. Current smokers or those who quit less than 12 months ago
10. History of gastrointestinal diseases or surgeries affecting digestion/absorption (except endoscopic removal of colon polyps)
11. Ongoing oral or dental bleeding issues expected to persist during the study
12. Vaccinated or planning vaccination (e.g., influenza, COVID-19) within 1 month before screening or during the study
13. Known lactose intolerance or excessive abdominal symptoms after dairy intake
14. Current or past drug or food allergies
15. Rotating shift workers who work night shift
16. Plan to significantly change lifestyle (diet, sleep, exercise) during the study
17. Plan to travel abroad during the study
18. Pregnant, breastfeeding, or planning pregnancy during the study
19. Blood donation or blood draw of 200mL within 1 month or 400mL within 3 months before screening
20. Participation in other clinical or monitoring studies within 1 month before screening or plans to participate during the study
21. Deemed unsuitable by the principal investigator for any other reason
Target Size - 150
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 09 Month 15 Day
Date of IRB - 2026 Year 09 Month 29 Day
Anticipated trial start date - 2026 Year 11 Month 06 Day
Last follow-up date - 2027 Year 03 Month 20 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072181
Disclaimer: Curated by HT Syndication.
