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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000021666 |
Receipt No. | R000024983 |
Scientific Title | The pilot study of effects of food containing plant constituents. |
Date of disclosure of the study information | 2016/04/01 |
Last modified on | 2016/10/26 |
Basic information | ||
Public title | The pilot study of effects of food containing plant constituents. | |
Acronym | The pilot study of effects of food containing plant constituents. | |
Scientific Title | The pilot study of effects of food containing plant constituents. | |
Scientific Title:Acronym | The pilot study of effects of food containing plant constituents. | |
Region |
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Condition | |||
Condition | Not applicable | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | In order to investigate the effect of food containing plant constituents in adults who have constipation tendency. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | intestinal microflora |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Cross-over |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Double blind -all involved are blinded |
Control | Placebo |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Prevention | |
Type of intervention |
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Interventions/Control_1 | Food containing plant constituents, feeding three times a day for 4 weeks in term1.
Placebo food not containing plant constituents, feeding three times a day for 4 weeks in term2. |
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Interventions/Control_2 | Placebo food not containing plant constituents, feeding three times a day for 4 weeks in term1.
Food containing plant constituents, feeding three times a day for 4 weeks in term2. |
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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)Healthy males aged 20 or more.
2)Subjects whose defecate between 3 to 5 times in a week in a week. 3)Subjects who don't take constantly use supplements and/or functional foods (including Food for Specified Health Uses and Foods with Function Claims) affecting the intestinal regulation, cholesterol, serum triglyceride, body fat. 4)Subjects who show understanding of the study procedures and agreement with participating the study by written informed consent prior to the study. |
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Key exclusion criteria | 1) Subjects whose systolic blood pressure is less than 90 mmHg.
2) Females who are pregnant or lactating, and females who could become pregnant or lactating during test period. 3) Subjects who donated 200 mL of blood and/or blood components within four weeks prior to the current study. 4) Males whose blood was collected more than 400 mL within the last twelve weeks. 5) Females whose blood was collected more than 400 mL within the last twelve weeks. 6) Subjects who are participating in other clinical studies for drug medicine or food, or who finished clinical study within four weeks. 7) Subject who are applicable to one of the below. a) Subject who are contracting heart, liver or kidney disease including the case of complicating disease. b) Subjects with a previous history of cardiovascular disease. c) Subjects who are contracting diabetes. d) Subjects who have allergy to test food. 8) Males whose blood was collected more than 1200 mL within the last twelve months when the amount of blood sampling in the current study is added. 9) Females whose blood was collected more than 800 mL within the last twelve months when the amount of blood sampling in the current study is added. 10) Subjects who underwent abdominal surgical operation within 6 month before test start. 11) Subjects who took antibiotics for 1 month or more within 6 month before test start. 12) Subjects who have an irregular sleep cycle, work shift or work on midnight shift. 13) Subjects who constantly use supplements and/or functional foods (including Food for Specified Health Uses, Foods with Function Claims). 14) Subjects who plan big change of lifestyle during test period. 15) Subjects with tendency of chronic diarrhea. 16) Subjects who considered unfitness for the test because of having previous and/or current medical history of serious disease of liver, kidney and heart. 17) Subjects who suspected chronic or acute infectious disease. |
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Target sample size | 24 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Suntory Global Innovation Center Ltd. | ||||||
Division name | Innovation Development Department | ||||||
Zip code | |||||||
Address | 8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0284, Japan | ||||||
TEL | 050-3182-0588 | ||||||
Norihito_Murayama@suntory.co.jp |
Public contact | |||||||
Name of contact person |
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Organization | Suntory Global Innovation Center Ltd. | ||||||
Division name | Innovation Development Department | ||||||
Zip code | |||||||
Address | 8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0284, Japan | ||||||
TEL | 050-3182-0599 | ||||||
Homepage URL | |||||||
Kenichi_Wakabayashi@suntory.co.jp |
Sponsor | |
Institute | Suntory Global Innovation Center Ltd. |
Institute | |
Department |
Funding Source | |
Organization | None |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization | Japan |
Other related organizations | |
Co-sponsor | MetaGen, Inc. |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
Address | |
Tel | |
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 | チヨダパラメディカルケアクリニック(東京都) |
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 | No longer recruiting | ||||||
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 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=R000024983 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |