Healthy adults
Conditions
Interventions
Take a capsule of the test food every morning after breakfast with cold or warm water.
Take a capsule of the placebo food every morning after breakfast with cold or warm water.
Sponsors
Nutrione Co., Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age: 20 to less than 60 years old 2. Gender: Japanese Male and female Japanese 3. BMI is between 25.0 and less than 30.0 kg/m2 4. Can write an electronic daily log using smartphones or PCs 5. Received an adequate explanation of the purpose of the study and voluntarily participated in the study under informed consent
Exclusion criteria
Exclusion criteria: 1. Have serious illnesses, or a history of malignant tumor in 6 months or serious illnesses. 2. Have took medicines, quasi-drug, foods or supplements affecting body weight and body fat, or treatment of obesity in one month. 3. Have had bariatric surgery in the past year or are planning to undergo surgery within 6 months after obtaining informed consent. 4. Are obese or overweight due to endocrine diseases, or under treatment or medication for gastrointestinal diseases, or have those history. 5. Have a psychologically serious medical history or illness, or a history of alcohol or other drug abuse. 6. Are judged to be unable to exercise due to skeletal muscle disease. 7. Have lost 3 kg or more of their body weight within the past 3 months. 8. Currently receiving any medical treatment with drugs or Chinese herbs. Medications used as needed are acceptable. 9. Receive diet or exercise therapy under medical supervision. 10. Have been taking quasi-drugs, foods, or supplements that affect the outcome of the study. Who can discontinue intake during the study is acceptable. 11. Have allergies to drugs or foods. 12. Shift workers. 13. Plans to extremely change lifestyle during the study. 14. Alcohol drinkers, over an average of 40 g/day. 15. Plans to travel abroad during the study period. 16. Are currently pregnant or breastfeeding, or planning to become pregnant during the study. 17. Have above 200 mL blood donation within one month, or above 400 mL blood donation within 3 months before this study. 18. Had joined other clinical trials from one month before the trial, have currently been joined other clinical trials, or plans to join other clinical trials during the study. 19. Are obsessed with orthopedic metal devices. 20. Are unsuitable for the study, judged by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -12-week changes in total body fat amount measured by DXA -12-week changes in body fat percentage measured by DXA | — |
Secondary
| Measure | Time frame |
|---|---|
| -12-week changes in Lean body mass -12-week changes in body weight -12-week changes in BMI -12-week changes in waist circumference, hip circumference, and ratio waist circumference to hip circumference -12-week changes in fat mass, fat percentage, and lean body mass in each region measured by DXA | — |
Countries
Japan
Contacts
Public ContactYoshitada Hira
IMEQRD Co., Ltd Planning and Sales Department
Outcome results
None listed