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A study to evaluate the effects of food ingredients on brain functio

Not Applicable
Conditions
Healthy subjects
Registration Number
JPRN-UMIN000052574
Lead Sponsor
HUMA R&D CORP
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
Male
Target Recruitment
40
Inclusion Criteria

Not provided

Exclusion Criteria

1.Receiving continuous pharmaceutical treatment with drugs including commercial pharmaceuticals and Chinese medicines due to some kind of illness excluding use as needed. 2.Receiving any dietary or exercise treatment under medical doctors. 3.Current or a history of mental disease, sleep disorder, hypertension, diabetes, dyslipidemia, or serious illness. 4.Current or a history of serious disorders of the liver, kidneys, heart, lungs, blood. 5.A gastrointestinal comorbidity or serious medical history. 6.Using implanted medical devices containing pacemakers or blood vessel clips. 7.A habit of taking drugs for treating diseases in past one month, excluding dismissal history of drugs for headaches, colds. 8.Have been taking any products (e.g., foods for specified health use, foods with functional health claims , health foods, drugs, quasi-drugs) that affect autonomic nervous system, metabolism and sleep, excluding who can quit intake during the study. 9.A constitutional difficulty in drinking alcohol. 10.At risk of developing hay fever or seasonal allergy symptoms or have allergic rhinitis during the study period. 11.Have or at risk of developing drug or food allergy symptoms. 12.Have difficulty wearing a heart rate monitor, such as an allergy to tape (such as bandage). 13.Alcohol drinkers, over 60 g/day of alcohol on daily basis. 14.Extremely irregular eating habits. 15.Night workers or Shift workers. 16.Under significant stress of any life event within 3 months before IC, or will have such a life event during the study period. 17.Have participated another clinical study within 1 month before IC, or will participate in it during the study period or within 1 month after the end of the study. 18.Cannot quit drinking from the day before the test date. 19.Have claustrophobia. 20.Current or a history of mental disorder containing depression.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
fMRI
Secondary Outcome Measures
NameTimeMethod
(Secondary outcomes) Questionnaire concerning psychological evaluation pulse rate (Safety evaluation) adverse events
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