Tokyo, Oct. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000056005) titled 'A verification study of the anti-obesity effect' on Oct. 16.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - ORTHOMEDICO Inc.

Condition: Condition - Healthy Japanese Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To verify the anti-obesity effect of consumption of the test food. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Duration: 12 weeks The test food Interventions/Control_2 - Duration: 12 weeks Placebo

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Japanese

2. Men or women

3. Adults

4. Healthy individuals

5. Individuals who defecate three to five times in Period 1

6. Individuals whose BMI is 23 kg/m2 or more and less than 30 kg/m2

7. Individuals who are classified as "Hidden Obese" or "Obese" in the body composition measurement at Scr Key exclusion criteria - Individuals who 1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction

2. have a pacemaker or an implantable cardioverter defibrillator (ICD)

3. are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

4. are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"

5. are taking or using medications (including herbal medicines) and supplements

6. are allergic to medicines and foods related to the test product

7. are pregnant, lactating, or planning to become pregnant during this study

8. have chronic constipation or diarrhea

9. have had diarrhea for at least 2 weeks prior to agreeing to participate

10. meet the diagnostic criteria for irritable bowel syndrome (IBS) or have already been diagnosed with IBS

11. have other diseases that may significantly affect bowel movement

12. usually take foods containing rich in lactic acid bacteria, or health foods or medicines fortified with lactic acid bacteria

13. usually take medicines, health foods, "Foods for Specified Health Uses," or "Foods with Functional Claims," that may affect bowel movement / take foods fortified with ingredients affecting bowel movement (e.g., fermented foods such as natto, kimchi, and pickles and foods fortified with dietary fiber)

14. have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study

15. are judged as ineligible to participate in this study by the physician Target Size - 30

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2024 Year 10 Month 16 Day Date of IRB - 2024 Year 10 Month 16 Day Anticipated trial start date - 2024 Year 10 Month 31 Day Last follow-up date - 2025 Year 04 Month 01 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063997

Disclaimer: Curated by HT Syndication.