Healthy adults
Conditions
Interventions
Oral ingestion of the test food for two weeks
Oral ingestion of the placebo food for two weeks
Sponsors
Morinaga & Co., Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Individuals aged 30-59 years. 2) Individuals who are healthy (BMI >=18.5 and <30). 3) Individuals who can visit an inspection facility and be inspected in designated days. 4) Individuals who can pedal the cycle ergometer for more than 30 minutes. 5) Individuals who don't have regular exercise more than twice a week now or in the past 6 months. 6) Individuals whose written informed consent has been obtained.
Exclusion criteria
Exclusion criteria: 1) Individuals who take foods more than three times a week with functional claims or foods or supplements containing Passienol-TM now or in the past 1 month, or will take them for this test period. 2) Individuals who take medications more than three times a week now or in the past 1 month, or will take them for this test period. 3) Individuals who take food for specified health use or foods with functional claims or supplements claiming to improve lipid metabolism more than three times a week now or in the past 1 month, or will take them for this test period. 4) Individuals who are allergic to especially foods or medicines or rubber. 5) Individuals who have currently or a history of hepatopathy, kidney damage, heart disease, lung, and gastrointestinal disease. 6) Individuals who were hospitalized in the past 6 months, or will be hospitalized for this test period. 7) Individuals who are currently treating anemia. 8) Individuals who are expected to have severe menstrual pain at one of the three cycle ergometer tests. 9) Females who are or are possibly pregnant, or are lactating. 10) Individuals who are a smoker. 11) Individuals who are heavy drinker of alcohol. 12) Individuals who have irregular life rhythms such as shift workers and late-night workers. 13) Individuals who participated in other clinical studies in the past 4 weeks, or will participate for this test period. 14) Individuals who donated total more than 200mL whole blood or blood component for the past 1 month. 15) Males who donated total more than 400mL whole blood for the past 3 months. 16) Females who donated total more than 400mL whole blood for the past 4 months. 17) Males who will donate total more than 1200mL blood for the past 12 months and this test period. 18) Females who will donate total more than 1200mL blood for the past 8 months and this test period. 19) Individuals judged inappropriate for this study by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expired-gas measurement (lipid oxidation, carbohydrate oxidation, respiratory quotient) | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum free fatty acid concentration, pulse rate (oxidative stress-antioxidant potential, concentration of serum lipid metabolites and hormones, oxygen consumption, and serum T-cho, LDL-Cho, HDL-Cho, TG and Glucose concentration) | — |
Countries
Japan
Contacts
Public ContactNaoko Matsui
MORINAGA & CO., LTD. Health Science and Research Center, R&D institute
Outcome results
None listed