Japanese men and women between 40 and 65 years old with a BMI between 18.5 kg/m2 and 30.0 kg/m2
Conditions
Interventions
One apple per day (300 g edible portion excluding peel and core) daily for 12 weeks
Sponsors
Food Research Institute, National Agriculture and Food Research Organization
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Subjects who fully understand the significance, content, and purpose of this study and have given written consent to participate in this study. (2) Japanese men and women between the ages of 40 and 65 years (3) BMI between 18.5 kg/m2 and 30.0 kg/m2
Exclusion criteria
Exclusion criteria: (1)Those who regularly take supplements that contain ingredients that may affect the results of this study(2) Those who are participating in other clinical trials at the start of this study(3) Who have ever complained of physical discomfort due to ingestion of apples or polyphenols(4) Patients with a history of heart failure or myocardial infarction(5) Excluded due to diseases(6) Those suffering from serious cerebrovascular disease, cardiac disease, liver disease, renal disease, gastrointestinal disease, or infectious disease requiring notification.(7) Those who have a history of major surgery on the digestive system, such as gastrectomy, gastrointestinal suture, or intestinal resection(8) Those with significant abnormalities in physical measurements, blood pressure measurements, or blood tests(9) Those with a low hemoglobin level(10) Women around menopause who show significant changes in their physical condition(11) Persons who may show allergic symptoms to drugs or foods(12) Excessive smokers: smokers who generally smoke 21 or more cigarettes per day(13) Regular users of alcohol: Those who generally drink more than 20 g of pure alcohol per day(14) Those whose lifestyle is extremely irregular: frequently skip two or more meals, eat out for dinner almost every day, work night shifts, or do not regularly take days off(15) Women who have donated 400 mL blood within 16 weeks prior to the start of intake, men who have donated 400 mL blood within 12 weeks prior to the start of intake, and those who have donated 200 mL blood within 4 weeks or component blood within 2 weeks prior to the start of intake(16) Women who are pregnant or possibly pregnant, or lactating(17) Any participant in any other clinical trial, observational study, clinical trial, or home use test between 4 weeks prior to the start of the study period and the end of the intake period(18) Any other person deemed ineligible by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gut microbiota analysis using feces | — |
Secondary
| Measure | Time frame |
|---|---|
| Physical measurements (height, weight, BMI, visceral fat area), blood tests (TC, LDL-C, HDL-C, TG, total bile acid, fasting blood glucose, HbA1c, insulin, (AST, ALT, gamma-GTP, ALP, LDH, 1.5-AG, total bile acid, CRP), dietary habits questionnaire (health food intake , diet and exercise habits, drinking and smoking habits, sleep duration), short-chain fatty acids, urinary metabolites | — |
Countries
Japan
Contacts
Public ContactToshihiko Shoji
Food Research Institute, National Agriculture and Food Research Organization Division of Food Function Research
Outcome results
None listed