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A study of the effect of continuous intake of test food on body composition, blood markers of glucose/lipid metabolism, blood pressure, and QoL: randomized, placebo-controlled, double blind, parallel-group trial

Not Applicable
Conditions
Healthy adults
Registration Number
JPRN-UMIN000049119
Lead Sponsor
IMEQRD Co., Ltd
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
66
Inclusion Criteria

Not provided

Exclusion Criteria

Subjects -- 1.who have been currently visiting a hospital or treated with any drug or herbal remedy for any disease. 2.with any of atopic dermatitis, bronchial asthma, chronic bronchitis, acute rhinitis, sinusitis, nasal polyp, hypertrophic rhinitis, deviated nasal septum. 3.who are on diet / exercise therapy under the guidance of a doctor. 4.who currently have or have history of severe diseases. 5.who are on desensitization therapy. 6.daily taking medicine, quasi-medicine, food for specified health uses or nutritional supplements / foods on the market that have health claims related to body fat or slimming. The subjects who can stop taking those medicine or foods during the study are also excluded. 7.daily taking medicine, quasi-medicine, food for specified health uses or nutritional supplements / foods other than criteria 6, except subjects who can stop taking those foods during the study. 8.daily consuming foodstuffs related to the test food with high frequency, except subjects who can refrain from taking these foodstuffs during the study. 9.who currently have or have a history of food and/or drug allergies. 10.who have or have a history of alcoholism or drug addiction. 11.who will take alcohol the day before the visit for tests. 12.routinely taking alcohol more than 60 g/day. 13.with excessive daily smoking: 20 cigarettes a day or more. 14.having plans of major change on their lifestyle (e.g., diet, sleep, and exercise) during the study period. 15.planning to travel abroad during the study period. 16.Currently pregnant, breast-feeding or planning to get pregnant during the study period. 17.who joined or are currently joining other clinical trials within 1 month before receiving informed consent in this study. 18.judged by the physician to be unsuitable for this study.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Body composition Blood markers test Blood pressure QoL questionnaire
Secondary Outcome Measures
NameTimeMethod
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