None listed
Conditions
Interventions
Oral injection of the test product with plant extracts (2 capsules per day
12 weeks)
Oral injection of the test product without plant extracts (2 capsules per day
Sponsors
Research & Development Institute, House Wellness Foods Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Healthy male and female subjects (>=40 to <70 years of age) (2) Subjects whose BMI values are between normal-high and obesity class 1 (>=23 to <30 kg/m2) (3) Subjects whose fasting blood glucose levels are <126 mg/dL and 2-hour blood glucose levels are <200 mg/dL during oral glucose tolerance test (4) Subjects who participate in this study with a written informed consent
Exclusion criteria
Exclusion criteria: (1) Subjects who have dietary carbohydrate restriction and try to lose weight or who plan to have dietary carbohydrate restriction and lose weight during the scheduled study period (2) Subjects who consecutively intake pharmaceutical and healthcare foods (which is possible to influence the results of this study) at 3 or more times per week (3) Subjects who plan to change their daily habit (diet, exercise) and living environment (changing residence, employee relocation, et al.) during the scheduled study period (4) Subjects with extremely irregular dietary habits (5) Subjects with excessive alcohol intake (6) Subjects with excessive smoking (7) Subjects who are positive for hepatitis C virus antibody or hepatitis B surface antigen (8) Subjects who allergies to medication or foods (especially soybean and gelatin) (9) Subjects who are participating in another trial, have participated in the past 4 weeks, or plan to participate in another trial during the scheduled study period (10) Females who have pregnancy, lactation, or plan to have pregnancy (11) Subjects who receive medical treatment or have a history of severe disease (12) Subjects who have made a platelet donation or a blood donation of 200 mL within one month prior to this study (13) Males who have made a blood donation of 400 mL within three months (14) Females who have made a blood donation of 400 mL within four months (15) Males who have made a blood donation over an amount (1200 mL minus the estimated volume of blood collected during to this study) within one year prior to this study (16) Females who have made a blood donation over an amount (800 mL minus the estimated volume of blood collected during to this study) within one year prior to this study (17) Subjects judged to be unsuitable for the study for other reasons by the investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pre-intervention (baseline) and at 4, 8, 12 weeks in the intervention Area under the curve (AUC) of blood glucose level | — |
Secondary
| Measure | Time frame |
|---|---|
| Pre-intervention (baseline) and at 4, 8, 12 weeks in the intervention 1. Matsuda-index 2. Homeostasis model assessment of insulin resistance (HOMA-IR) 3. Fasting blood glucose level 4. Hemoglobin A1c (HbA1c) 5. High sensitive C-reactive protein (CRP) 6. Body weight 7. Body mass index (BMI) | — |
Countries
Japan
Contacts
Public ContactRyusei Uchio
House Wellness Foods Corporation Research & Development Institute
Outcome results
None listed