Tokyo, April 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061183) titled 'A randomized, double-blind, placebo-controlled, parallel-group comparative study of the effects of continuous probiotics intake on reducing abdominal visceral fat in healthy adult men' on April 10.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - KSO corporation
Condition:
Condition - None
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the anti-obesity effects of continuous probiotic ingestion.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Intake of test foods for 12 weeks.
Interventions/Control_2 - Intake of placebo foods for 12 weeks.
Eligibility:
Age-lower limit - 20
years-old
Gender - Male
Key inclusion criteria - 1) Male participants aged 20 to 64 years at the time of obtaining consent.
2) Participants of BMI between 23 kg/m2 and less than 30 kg/m2.
3) Participants who fully understand the purpose and content of this study and agree to participate in this study with a written informed consent.
Key exclusion criteria - 1) Participants with serious diseases (such as cerebrovascular diseases, cardiovascular diseases, liver diseases, gastrointestinal diseases, endocrine and metabolic diseases, or sleep apnea syndrome), or history of these diseases.
2) Participants who regularly take medications that may affect obesity, dyslipidemia, or lipid metabolism.
3) Participants who cannot stop taking health foods or supplements that affect obesity, dyslipidemia or lipid metabolism during the study.
4) Participants who cannot stop consuming foods/supplements containing lactobacilli, bifidobacteria, or oligosaccharides during the study.
5) Participants with a habitual heavy smoking (average of >=21 cigarettes per day).
6) Participants with excessive alcoholic drinks (average daily pure alcohol intake >=60 g).
7) Participants with severe medication or food allergies.
8) Participants with metal in the CT scan measurement site due to surgery, etc.
9) Participants with cardiac pacemakers or implantable cardioverter defibrillators.
10) Participants with claustrophobia that may interfere with CT scanning procedures.
11) Participants judged to have a muscular body type based on their body composition measurements at the screening, as determined by the principal investigator.
12) Participants with a history of digestive tract diseases or digestive tract surgery (except appendicitis).
13) Participants who cannot abstain from alcohol for 2 days before and during evaluation.
14) Participants with a history or current diagnosis of drug dependence or alcohol dependence.
15) Participants with extremely irregular dietary habits, shift workers, or night-shift workers.
16) Participants who have donated >200 mL blood in 1 month, or >400 mL in 3 months before consent.
17) Participants who are currently participating or intend to participate other clinical trials during the study.
18) Participants judged ineligible to this study by principal investigator.
Target Size - 116
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 04 Month 02 Day
Date of IRB - 2026 Year 04 Month 02 Day
Anticipated trial start date - 2026 Year 06 Month 28 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070016
Disclaimer: Curated by HT Syndication.
