Diet effect confirmation test ~Diet test by ingesting The fermentation hydrogen 328 selections Mogitate Nama-smoothie and The Fermentation hydrogen 328 selections Nama-supplement Nen.~ -Open study
- Conditions
- Healthy adult
- Registration Number
- JPRN-UMIN000041238
- Lead Sponsor
- KSO Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 30
Not provided
(1) Subjects who have been diagnosed with severe anemia by the results of screening test. (2) Subjects who regularly take medicines. (3) Subjects who cannot stop taking drugs, supplements, and health foods that may affect obesity, hyperlipidemia, lipid metabolism, etc. during the test period. (4) Subjects who suffers from urgent medical treatment or has serious complications. (5) Subjects with a digestive organ disease or surgical history that has an influence on digestive absorption. (6) Subjects who taking supplements and health foods. (7) Subjects who have allergic to the test food ingredients. (8) Those who are allergic to orange, cashew nut, kiwifruit, sesame, soybean, banana, peach, walnut, apple, yam, almond, wheat, gelatin. (9) Subjects who are pregnant or breast-feeding, or have the will of pregnancy during the study period. (10) Subjects who has metal in DUAL SCAN measurement site due to surgery etc. (11) Subjects who have implantable medical devices such as cardiac pacemakers or implantable defibrillators. (12) Subjects who cannot stop drinking more than 20g per day equivalent to pure alcohol. (13) Subjects who has a medical history or current medical history of drug dependence or alcohol dependence. (14) Subjects who are shift workers or midnight workers. (15) Those who have been diagnosed with familial hyperlipidemia. (16) Subjects who participate in other clinical studies or who are in willing to participate to these studies using foods, drugs and/or cosmetics. (17) Subjects who are judged as unsuitable for the study by the investigator for the other reasons.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Abdominal Visceral Fat Area
- Secondary Outcome Measures
Name Time Method <Efficacy> 1) Weight (BMI)(Visit date) 2) Weight (From ingestion start date to the day before 12W) 3) Body temperature (From ingestion start date to the day before 12W) 4) SFA, TFA 5) Waist circumference / Hip circumference 6) Body fat percentage, body fat mass, muscle mass 7) Biochemical examination 8) Skin, physical condition and cold questionnaire(VAS) <Safety> 1) Interview 2) Blood pressure/pulse rate 3) Hematology test 4) Biochemical examination 5) Urinalysis 6) Subjective symptoms 7) Adverse events