Healthy subjects
Conditions
Interventions
Consumption of the test food three times a day for 12 weeks.
Consumption of the placebo food three times a day for 12 weeks.
Sponsors
Clinical Support Corporation Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese males and females who aged 20 to 65 at the time of informed consent. 2. Subjects whose BMI is 23 or more and less than 30 at screening. 3. Subjects who have breakfast, lunch, and dinner every day. 4. Those who can attend the examination site on the days of visit. 5. Those who can make self judgment to participate the study and are voluntarily giving written informed consent with signature and date.
Exclusion criteria
Exclusion criteria: 1. Subjects who have a medical history of liver disease, kidney disease, cardiac disease, organ disorder, diabetes, and other serious diseases. 2. Subjects who have a history of gastrointestinal resection (excluding appendectomy and Endoscopic polypectomy). 3. Subjects who have a medical history of ileus, esophageal stricture and Abnormal intestinal narrowing. 4. Subjects who have chronic medical diseases under treatment. 5. Subjects who have a pacemaker or an implantable cardioverter defibrillator. 6. Subjects who are allergic to the test food (apple). 7. Subjects who are pregnant, lactation or planning to become pregnant. 8. Subjects whose daily average amount of drinking as pure alcohol is over 60 g. 9. Subjects Whose daily average number of smoking cigarettes is 21 or more. 10. Subjects who ingest pharmaceuticals, herbal medicines, and health foods for the purpose of weight loss. 11. Subjects who use engineered food or health foods high in dietary fiber that have a potentially effect on weight and lipid absorption. 12. Subject who are participating in other clinical studies. Or subject who plan to participate in the middle of this trial. 13. Subjects who are donated blood components 200 mL or more within a month before the screening test in this trial. Or subject who plan to donate blood components. 14. Subjects who have a habit of without a meal. 15. Subjects who work during 22 to 6 o'clock (including part-timer, as night shift worker). 16. Subjects who cannot prepare the test food according to instructions and take those three times when each meal. 17. Subjects who need to avoid consuming food whose origin is not clearly indicate due to religious or other reasons. 18. Subjects who are judged as ineligible to participate in the study by the physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visceral fat area | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Abdominal subcutaneous fat area and Abdominal total fat area 2. Body-mass index, Body weight, waist circumference and waist-hip ratio 3. Gut microbiota 4. Short chain fatty acids and bile acids in gut 3. Gut PH | — |
Countries
Japan
Contacts
Public ContactIsao Takehara
Clinical Support Corporation Limited Food Service Division
Outcome results
None listed