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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000028319 |
Receipt No. | R000032412 |
Scientific Title | Safety Evaluation for Excessive Ingestion of Food Containing Pinitol |
Date of disclosure of the study information | 2017/07/21 |
Last modified on | 2019/02/28 |
Basic information | ||
Public title | Safety Evaluation for Excessive Ingestion of Food Containing Pinitol | |
Acronym | Safety of Excessive Ingestion of Food Containing Pinitol | |
Scientific Title | Safety Evaluation for Excessive Ingestion of Food Containing Pinitol | |
Scientific Title:Acronym | Safety of Excessive Ingestion of Food Containing Pinitol | |
Region |
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Condition | |||
Condition | Healthy adults | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate the food safety containing 3 times high amount of recommended Pinitol for 4 weeks daily. |
Basic objectives2 | Safety |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | Pragmatic |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | The pattern, severity and frequency of side effects related to ingestion of the active test food during the ingestion period and the post ingestion period. |
Key secondary outcomes | The pattern, severity and frequency of adverse events during the ingestion period and the post ingestion period.
BW, BFP, BMI, BP measured at the hospital, heart rate, hematological test (WBC, RBC, Hb, Ht, and Plt), biochemical test (AST, ALT, gamma-GTP, ALP, LDH, BUN, CRE, UA, TC, LDL-C, HDL-C, TG, serum total protein, albumin, total bilirubin, A/G ratio, CPK, serum amylase, Na, Cl, K, Ca, P, Fe, UIBC and TIBC) and urine analysis (pH, protein, sugar, urobilinogen, bilirubin, ketone bodies and occult blood) after 2 and 4 weeks of ingestion and 2 weeks after the end of ingestion. |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Double blind -all involved are blinded |
Control | Placebo |
Stratification | YES |
Dynamic allocation | NO |
Institution consideration | Institution is not considered as adjustment factor. |
Blocking | YES |
Concealment | No need to know |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Ingestion of nine capsules containing pinitol daily for 4 weeks. | |
Interventions/Control_2 | Ingestion of nine placebo capsules daily for 4 weeks. | |
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1. Subjects who meet the following criterion either a or b.
a. Subjects whose FBG is>=100 mg/dl and <126 mg/dl or HbA1c >=5.6% and <6.5%. b. Subjects whose FBG is>=70 mg/dl and <100 mg/dl and HbA1c >=4.6% and <5.6%. 2. Subjects who agree to participate in this study with a written informed consent. |
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Key exclusion criteria | 1. Subjects who are under physician's advice, treatment and/or medication for diabetes.
2. Subjects whose HbA1c is >=6.5% 3. Subjects whose FBG is >=126 mg/dl. 4. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities. 5. Subjects with major surgical history relevant to digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc. 6. Subjects with unusually high and/or low blood pressure and/or abnormal hematological data. 7. Subjects with severe anemia. 8. Pre- or post-menopausal women complaining obvious physical changes. 9. Subjects who are at risk of having allergic reactions to drugs or foods based on especially leguminous plants including soybeans, and ice plants, yeasts, gelatin and milk. 10. Subjects who regularly take medicine, functional foods and/or supplements (containing dietary fiber such as indigestible dextrin, polyphenol, etc.) which would affect glucose metabolism. 11. Heavy smokers, alcohol addicts or subjects with the eating disordered lifestyle. 12. Subjects who donated either 400ml whole blood within 16 weeks (women) /12 weeks (men) or 200ml whole blood within 4 weeks or blood components within 2 weeks prior to the current study. 13. Pregnant or lactating women or women expect to be pregnant during this study. 14. Subjects who currently participate in other clinical trials or participated within the last 4 weeks prior to the current study. 15. Any other medical and/ or health reasons unfavorable to participation into the current study judged by the principal investigator. |
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Target sample size | 64 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Hokkaido Information University | ||||||
Division name | Department of Medical Management and Informatics | ||||||
Zip code | |||||||
Address | 59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan | ||||||
TEL | 011-385-4411 | ||||||
nishihira@do-johodai.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Hokkaido Information University | ||||||
Division name | Health Information Science Center | ||||||
Zip code | |||||||
Address | 59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan | ||||||
TEL | 011-385-4430 | ||||||
Homepage URL | |||||||
nishihira@do-johodai.ac.jp |
Sponsor | |
Institute | Hokkaido Information University |
Institute | |
Department |
Funding Source | |
Organization | The Ethics Committee approves that the source of funding shall not be disclosed. |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization | Japan |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
Address | |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions | 北海道情報大学 保健センター(北海道) |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032412 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |