NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000052666

Registered date:01/12/2023

Effects of consumption of the test food on waist circumference (abdominal circumference) in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedHealthy Japanese
Date of first enrollment2023/11/01
Target sample size90
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Duration: 12 weeks Test food: A plant-derived food Administration: Take three tablets once per day with water immediately before snack or dinner. *If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day. Duration: 12 weeks Test food: Placebo Administration: Take three tablets once per day with water immediately before snack or dinner. *If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.

Outcome(s)

Primary Outcome1. The measured value of waist circumference at 12 weeks after consumption (12w)
Secondary Outcome1. The measured value of waist circumference at eight weeks after consumption (8w) 2. The amount and rate of changes of waist circumference between screening (before consumption; Scr) and 8w, or 12w 3. The measured values of body weight, body mass index (BMI), body fat percentage, hip circumference, thigh circumference, lean body mass, muscle mass, fat mass, total cholesterol (T-Cho), high density lipoprotein-cholesterol (HDL-Cho), low density lipoprotein-cholesterol (LDL-Cho), and triglyceride (TG) at 8w and 12w, and the amount and rate of changes of them from Scr

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum65years-old
GenderMale and Female
Include criteria
Exclude criteriaIndividuals (who/whose) 1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. 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. take herb or foods with hypoglycemic effects 6. are taking medications (including herbal medicines) and supplements 7. are allergic to medicines and/or the test food related products 8. notice a weak stomach and may feel discomfort such as convergence in the stomach, particularly when taking beverages containing tannin such as green tea, black tea, or coffee 9. have irregular lifestyles (such as diet, exercise, and sleep) 10. weekly average of pure alcohol intake is more than 60 g/day 11. are pregnant, lactating, or planning to become pregnant during this trial 12. have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 13. have donated blood component or 200 mL whole blood within the last one month before the agreement to participate in this trial 14. have donated 400 mL whole blood within the last three month before the agreement to participate in this trial 15. are scheduling to have a total of more than 1,200 mL of blood drawn until the end of this study from the 12 months before the date of consent obtained 16. are judged as ineligible to participate in this study by the physician

Related Information

Contact

public contact
Name Naoko Suzuki
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan Japan 112-0002
Telephone 03-3818-0610
E-mail nao@orthomedico.jp
Affiliation ORTHOMEDICO Inc. R&D Department
scientific contact
Name Tsuyoshi Takara
Address 9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan Japan
Telephone 03-5793-3623
E-mail t-takara@takara-clinic.com
Affiliation Medical Corporation Seishinkai, Takara Clinic Director