UMIN-CTR Clinical Trial
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|Unique ID issued by UMIN||UMIN000031372|
|Scientific Title||Effects and Safety of the Test Food on Lipid Metabolism and Antioxidation Performance of Healthy Adults or Individuals with Borderline Fasting Blood Sugar Level.|
|Date of disclosure of the study information||2018/02/23|
|Last modified on||2018/12/04|
|Public title||Effects and Safety of the Test Food on Lipid Metabolism and Antioxidation Performance of Healthy Adults or Individuals with Borderline Fasting Blood Sugar Level.|
|Acronym||Effects and Safety of the Test Food on Lipid Metabolism and Antioxidation Performance of Healthy Adults or Individuals with Borderline Fasting Blood Sugar Level.|
|Condition||N/A (healthy adults)|
|Classification by specialty||
|Classification by malignancy||Others|
|Narrative objectives1||This study aims to examine effects and safety of the test food on lipid metabolism and antioxidation performance of healthy adults or individuals with borderline fasting blood sugar level.|
|Basic objectives -Others|
|Primary outcomes||Indexes for efficacy and safety (lipid metabolism evaluation [fasting blood sugar level, HbA1c, glycoalbumin, insulin, HOMA-R(1)](2), antioxidation performance evaluation [d-ROMs test: oxidative stress, BAP test: antioxidation performance, BAP/d-ROMs ratio(1)](3), and safety evaluation [number of cases and expression rate of side effects [expression rate: number of cases/number of cases analyzed](4)).
(2)Screening, Week 0, Week 4, Week 8, Week 12.
(3)Week 0, Week 8, Week 12.
(4)After intake period.
|Key secondary outcomes||*Secondary outcomes
Adverse events: number of cases and expression rate of adverse events (expression rate: number of cases/number of cases analyzed) (SCR, Week 0, Week 4, Week 8, Week 12)
Blood test (pentosidine, carboxymethyl lysine)
Blood pressure, pulsation (SCR, Week 0, Week 4, Week 8, Week 12)
Weight, body fat percentage, BMI (SCR, Week 0, Week 4, Week 8, Week 12)
Hematologic test (SCR, Week 0, Week 4, Week 8, Week 12)
Blood biochemical test (SCR, Week 0, Week 4, Week 8, Week 12)
Urine analysis (SCR, Week 0, Week 4, Week 8, Week 12)
Anti-Aging QOL Common Questionnaire (SCR, Week 4, Week 8, Week 12)
Doctor's questions (SCR, Week 0, Week 4, Week 8, Week 12)
Subject's diary (each day during the test period)
Dietary survey (3 days prior to each inspection date)
|Blinding||Double blind -all involved are blinded|
|No. of arms||2|
|Purpose of intervention||Treatment|
|Type of intervention||
|Interventions/Control_1||Oral intake of the test food (118g in a day; 12 weeks).|
|Interventions/Control_2||Oral intake of the placebo food (118g in a day; 12 weeks).|
|Gender||Male and Female|
|Key inclusion criteria||Males and females aged 20-65 years.
Individuals who are healthy and have no chronic physical disease.
Individuals whose fasting blood glucose is over 100mg/dL and less than 110mg/dL or over 110mg/dL and less than 126mg/dL.
Individuals whose BMI is over 18.5 and under 30.
Individuals whose written informed consent has been obtained.
Individuals who can come to the designated venue for this study and be inspected.
Individuals judged appropriate for the study by the principal.
|Key exclusion criteria||Individuals using medical products.
Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia.
Individuals who used a drug to treat a disease in the past 1 month (except temporal usage for pollenosis).
Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease.
Individuals who are a patient or have a history of or endocrine disease.
Individuals whose fasting blood glucose is over 126mg/dL or HbA1c (NGSP) is over 6.5%.
Individuals whose systolic and diastolic blood pressures are over 140mmHg and 90mmHg, respectively.
Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months.
Individuals who experienced unpleasant feeling during blood drawing.
Individuals who are sensitive to a test product or other foods, and medical products.
Individuals who habitually take the foods for specified health uses (FOSHU) or functional food (except for subjects who can stop consume them after informed consent).
Individuals who have a habit to intake a product similar with a test food.
Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day).
Individuals with possible changes of life style, such as conducting a long-term travel, during the test period.
Individuals who are or are possibly, or are lactating.
Individuals who participated in other clinical studies in the past 3 months.
Individuals who are or whose family is engaged in functional foods or cosmetics.
Individuals judged inappropriate for the study by the principal.
|Target sample size||44|
|Research contact person|
|Name of lead principal investigator||
|Organization||Otsubokai Medical Corporation Tohto Bunkyo Hospital|
|Address||3-5-7 Yushima Bunkyo-ku Tokyo 113-0034, JAPAN|
|Name of contact person||
|Organization||TES Holdings Co., Ltd|
|Division name||Administrative Department of Clinical Trials|
|Address||6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN|
|Institute||TES Holdings Co., Ltd|
|Organization||Hakkaisan Brewery Co., Ltd.|
|Category of Funding Organization||Profit organization|
|Nationality of Funding Organization|
|Other related organizations|
|Name of secondary funder(s)|
|IRB Contact (For public release)|
|Org. issuing International ID_1|
|Org. issuing International ID_2|
|IND to MHLW|
|Other administrative information|
|Date of disclosure of the study information||
|URL releasing protocol|
|Publication of results||Unpublished|
|URL related to results and publications|
|Number of participants that the trial has enrolled|
|Results date posted|
|Results Delay Reason|
|Date of the first journal publication of results|
|Plan to share IPD|
|IPD sharing Plan description|
|Date of protocol fixation||
|Date of IRB|
|Anticipated trial start date||
|Last follow-up date|
|Date of closure to data entry|
|Date trial data considered complete|
|Date analysis concluded|
|Other related information|
|Last modified on||
|Link to view the page|
|Registered date||File name|
|Research case data specifications|
|Registered date||File name|
|Research case data|
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