A study to evaluate effects of daily test food on blood parameters in a healthy adult subjects

Not Applicable

• Conditions: /A

• Registration Number: JPRN-UMIN000037370
• Lead Sponsor: Research & Development Institute, House Wellness Foods Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-16
• Study Completion: 2019-12-08
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)