Healthy subjects
Conditions
Interventions
4-week ingestion of the test food Wash out(5 weeks or more) 4-week ingestion of the placebo food
4-week ingestion of the placebo food Wash out(5 weeks or more) 4-week ingestion of the test food
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Japanese men and women aged between 35 and 65 years old at the time of obtaining written consent. 2)Subject with BMI >=25kg/m2 and <30kg/m2. 3)Non-smoker 4)Subject with alcohol intake less than 30g/day. 5)Subject who has received sufficient explanation of the purpose and content of the research, has the ability to consent.
Exclusion criteria
Exclusion criteria: 1.Subject who is taking medication or under medical treatment due to serious illness. 2.Subject who has experienced chest pain or abnormal pulse at rest. 3.Subject who is under exercise therapy or dietetic therapy. 4.Subject with serious current illness or complications or history such as heart disease, liver disease, kidney disease, cardiovascular disease, blood disease, etc. 5.Subject who is receiving the rheumatism treatment. 6.Subject who frequently has shortness of breath, lightheadedness, dizziness or loss of consciousness. 7.Subject who might has or has a history of drug allergies, food allergies, allergies to test foods, or allergies to raw materials for evaluated foods(soybeans, milk protein, pork). 8.Subject who has difficulty ingesting test foods and evaluation foods. 9.Subject who has a family member who died suddenly of unknown causes. 10.Subject who has been diagnosed as having problems with the legs and hips. 11.Subject who feels pain in their hips, knees, or body when ascending or descending stairs, etc. 12.Subject with knee surgery or disease, or those who use a cane on a daily basis. 13.Subject with current or history of drug or alcohol dependence. 14.Subject who attends a hospital due to mental disorders (depression, etc.) or sleep disorders (Insomnia, sleep apnea syndrome, etc.), or who has a history of mental illness in the past. 15.Subject who exercises for the purpose of maintaining or improving their physical fitness for a total of 60 minutes or more per week.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stable isotope excretion after test meals (during rest), fatty acid conversion, respiratory exchange ratio (during exercise) | — |
Secondary
| Measure | Time frame |
|---|---|
| (Secondary outcomes) Postprandial body heat production (during rest), carbohydrate oxidation (during exercise), visceral fat measurement, heart rate variability (Safety evaluation) Vital signs, body measurements(weight,BMI), adverse events | — |
Countries
Japan
Contacts
Public ContactHidemasa Toya
HUMA R&D CORP Clinical Development Department
Outcome results
None listed