Effects of consumption of the test food on body fat: a randomized, double-blind, placebo-controlled, parallel-group trial

Not Applicable

Completed

• Conditions: Japanese subjects between 23 kg/m2 or more and less than 30 kg/m2 in body mass index (BMI)

• Registration Number: JPRN-UMIN000034316
• Lead Sponsor: ORTHOMEDICO Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-28
• Study Completion: 2019-04-27
• Last Update Posted: 2023-10-17

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

Not provided

Exclusion Criteria

1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily 5. Subjects who excessive exercise 6. Subjects who are currently taking medications (including herbal medicines) and supplements 7. Subjects who could have any allergens in raw materials of the test food (soybean and gelatin), or possible to have serious allergic reactions to other foods and/or medicines 8. Subjects who are pregnant, lactation, or planning to become pregnant 9. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to enroll in anther clinical trial during trial period 10. Subjects who are judged as ineligible to participate in the study by the physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified