Tokyo, July 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058391) titled 'A randomized, double-blind, placebo-controlled, parallel-group, exploratory study of the effects of probiotic intake on various health indicators' on July 7.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - TES Holdings Co., Ltd.
Condition:
Condition - No
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate the effects of the consumption of the test foods on various health indices of the subjects from multiple perspectives.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Oral intake of the test food (1 stick per day; 12 weeks).
Interventions/Control_2 - Oral intake of the control food (1 stick per day; 12 weeks).
Eligibility:
Age-lower limit - 50
years-old
Gender - Male and Female
Key inclusion criteria - 1) Individuals who are between 50 and 75 years of age at the time of obtaining consent to participate in the study.
2) Individuals who wear a pedometer on a daily basis and are able to measure the number of steps taken.
3) Individuals who have been fully informed of the purpose and content of the study, have the capacity to consent, and have voluntarily volunteered to participate in the study based on a thorough understanding of the purpose and content of the study, and who have agreed to participate in the study in writing.
4) Individuals who are able to come to the hospital on the designated examination date and undergo the examination.
Key exclusion criteria - Individuals
1) undergoing treatment for chronic diseases, etc.
2) suffering from or with a history of serious diseases such as malignant tumors, respiratory diseases, liver, kidney, heart, lung, digestive and metabolic systems
3) suffering from or with a history of intestinal diseases.
4) who suffer from or have a history of sleep disorders, psychiatric disorders, drug dependence, or alcohol dependence.
5) with severe anemia.
6) with drug or food allergies or a history of allergies.
7) who regularly use medicines, including laxatives, bowel movements or laxatives.
8) who have taken antibiotics for more than one week within three months.
9)who cannot discontinue food for specified health use, food with functional claims, food with nutrient function claims, supplements, and beverages or foods containing bifidobacteria, lactic acid bacteria, or oligosaccharides during the study period.
10)who have a smoking habit.
11) who consume excessive amounts of alcohol (average of more than 40g/day of pure alcohol per week) and individuals who are unable to abstain from alcohol during the 7days prior to testing.
12) Premenopausal or postmenopausal women within 3years of menopause.
13) Women whose FSH level is less than 40mIU/ml or estradiol level is greater than 20pg/ml.
14)with a Body Mass Index (BMI) of 30kg/m2 or more.
15)with excessive exercise habits.
16) who may change their lifestyle during the study period.
17) who have had blood drawn or donated more than 200mL within 1month of the screening test or 400mL within 3months.
18) who have participated in other drug or food trials within the past month, or who are willing to participate in these trials.
19) who are judged by the investigator to be unsuitable as subjects based on the results of the subject's background, physical examination, physical examination, and clinical examination.
Target Size - 96
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 05 Month 21 Day
Date of IRB - 2025 Year 06 Month 18 Day
Anticipated trial start date - 2025 Year 09 Month 16 Day
Last follow-up date - 2025 Year 12 Month 19 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066611
Disclaimer: Curated by HT Syndication.
