None listed
Conditions
Interventions
Oral injection of the test product with a plant extract (2 tablets per day
12 weeks)
Oral injection of the test product without a plant extract (2 tablets per day
Sponsors
Research & Development Institute, House Wellness Foods Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Males and females aged 50 to 69 years when informed consent (2) Subjects whose BMI values are between normal-high and obesity class 1 (>=23 and <30) (3) Subjects whose blood glucose levels <126 mg/dL (4) Subjects whose blood high-density cholesterol (HDL-Cho) levels >=35 mg/dL (5) Subjects who participate in this study with a written informed consent
Exclusion criteria
Exclusion criteria: (1) Subjects who are positive for hepatitis C virus antibody or hepatitis B surface antigen (2) Subjects using medications or health foods that could possibly influence the results of this study (3) Subjects with a history of heart disease, liver disease, kidney disease, or gastrointestinal disease (4) Subjectswith a history of circulatory disease (5) Subjects with excessive alcohol intake. (6) Subjects who are excessive smoker. (7) Subjects who have extremely irregular dietary habits (8) Subjects who allergies to medications 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) Subjects who have made a blood donation within one month prior to this study (11) Males who have made a blood donation of 400 mL within three months prior to this study (12) Females who have made a blood donation of 400 mL within four months prior to this study (13) Males who have made a blood donation over an amount (1200 mL minus the estimated volume of blood collected during the study) within one year prior to this study (14) Females who have made a blood donation over an amount (800 mL minus the estimated volume of blood collected during the study) within one year prior to this study (15) Persons judged to be unsuitable for the study for other reasons by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At 0, 4, 8, 12 weeks in the intervention (1) C-reactive protein (CRP) (2) Tumor necrosis factor-alpha (TNF-alpha) (3) Interleukin-6 (IL-6) (4) Soluble vascular cell adhesion molecule-1 (sVCAM-1) | — |
Secondary
| Measure | Time frame |
|---|---|
| At 0, 4, 8, 12 weeks in the intervention (1) Complement C3 (C3) (2) Complement C4 (C4) (3) Fibrinogen (FIB) (4) Glucose (GLC) (5) Hemoglobin A1c (HbA1c) (6) Insulin (IRI) (7) Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) (8) Glucagon (9) Total cholesterol (T-Cho) (10) Low-density lipoprotein cholesterol (LDL-Cho) (11) High-density lipoprotein cholesterol (HDL-Cho) (12) High-density lipoprotein cholesterol /low-density lipoprotein cholesterol ratio (HDL/LDL ratio) (13) Non-high-density lipoprotein cholesterol (non-HDL Cho) (14) Adiponectin (15) Leptin (16) Amyloid-beta peptide 1-40 (A-beta40) (17) Amyloid-beta peptide 1-42 (A-beta42) (18) Mild cognitive impairment (MCI) screening (apolipoprotein A1 (ApoA1), inactive form of C3, transthyretin) (19) Addenbrooke's Cognitive Examination III(ACE-III) (20) Profile of mood states-2nd edition (POMS-2) short versions (21) MOS 36-Item short form version 2 (SF-36v2; acute) | — |
Countries
Japan
Contacts
Public ContactRyusei Uchio
House Wellness Foods Corporation Research and Development Institute
Outcome results
None listed