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Investigation of the effectiveness of whole wheat bread intake for 12 weeks against metabolic syndrome index: Effects on visceral fat area, fasting blood glucose and serum lipids.

Not Applicable
Conditions
Healthy subjects ( BMI &gt
= 23.0 kg/m2)
Registration Number
JPRN-UMIN000018673
Lead Sponsor
CPCC Company Limited
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
50
Inclusion Criteria

Not provided

Exclusion Criteria

(1) Subjects who have continuous intake of Divaricate Saposhnikovia Miraculous Powder. (2) Subjects who take drugs to treat dyslipidemia. (3) Subjects who experienced body weight changes >= 10% within a year before the start date of this study. (4) Fasting blood glucose >=126 mg/dl or HbA1c (NGSP) >=6.5% or diabetic patient. (5) Subjects who have previous and/or current medical history of serious disease (e.g., heart, liver, kidney, digestive organ). (6) Subjects who have history of surgery in gastrointestinal tract. (7) Subjects who have history of malignant diseases. (8) Females who are pregnant or lactating, and who could become pregnant or lactating during test period. (9) Subjects who have excessive alcohol intake. (10) Subjects who have extremely irregular dining habits, and who have midnight work or irregular shift work. (11) Subjects who have continuous intake of dietary fiber supplement or whole grain. (12) Subjects who have serious infectious diseases. (13) Subjects who have previous medical history of drug and/or food allergy. (14) Subjects who are participating in other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate in other clinical tests. (15) Subjects who donated over 200mL blood and/or blood components within the last one month. (16) Males who donated over 400mL blood within the last three month. (17) Females who donated over 400mL blood within the last four month. (18) Males who will be collected over 1200 mL of blood when the planned sampling volume in this study is added to the volume collected within the last 12 months. (19) Females who will be collected over 800 mL of blood when the planned sampling volume in this study is added to the volume collected within the last 12 months. (20) Subjects who are not eligible for this study for some medical reasons.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
metabolic syndrome index (visceral fat area, serum lipids) It will be measured at week 0, 6, and 12.
Secondary Outcome Measures
NameTimeMethod
Blood HbA1c, serum insulin, leptin, adiponectin levels, fasting blood glucose, blood pressure
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