UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033528 |
|---|---|
| Receipt number | R000038197 |
| Scientific Title | An exploratory study of the effects of continuous intake of high gamma PGA natto on physique and glucose and lipid metabolism. |
| Date of disclosure of the study information | 2018/07/30 |
| Last modified on | 2020/07/27 09:23:57 |
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Basic information
Public title
An exploratory study of the effects of continuous intake of high gamma PGA natto on physique and glucose and lipid metabolism.
Acronym
A pilot study of high gamma PGA natto continuous intake
Scientific Title
An exploratory study of the effects of continuous intake of high gamma PGA natto on physique and glucose and lipid metabolism.
Scientific Title:Acronym
A pilot study of high gamma PGA natto continuous intake
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy of the high gamma PGA natto on physique and glucose and lipid metabolism.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood lipid level(TG, HDL-C, LDL-C, TC) at 12 weeks.
Key secondary outcomes
1.Body weight, Waist circumference
2.Blood pressure
3.Biomarkers(fasting blood gulcose, HbA1c, insulin, C-peptide, AST, ALT, amma GTP, BUN, Cr, UA, FFA, TP, Alb)
4.Amount of test meal consumption
5.Defecation frequency
6.Organoleptic evaluation
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Low gamma PGA natto.
40g per day for 6weeks.
Interventions/Control_2
High gamma PGA natto.
40g per day for 6weeks.
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
| 40 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.BMI not less than 23.0 kg/m2, under 25.0 kg/m2
2. Capable of giving informed consent.
Key exclusion criteria
1. Fasting blood glucose not less than 126 mg/dL and/or HbA1c not less than 6.5%
2. TG not less than 200 mg/dL and/or LDL-C not less than 160 mg/dL
3. SBP not less than 160 mmHg and/or DBP not less than 100 mmHg
4. Subjects who are treated for diabetes and/or hyperlipidemia and/or hypertension.
5. Subjects who are habitually taking supplement (including "food for specified health use", and "foods with function claims") that include lactic acid bacterium, bifidobacteria, oligosaccharide, dietary fiber, and ingredients of natto.
6. Subjects who are enrollment in another interventional study
7. Subjects who were recognized unsuitable for this study by the Investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Hashimoto |
Organization
University of Tsukuba, Faculty of Medicene
Division name
Clinical and Translational Research Methodology
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
029-853-3064
koichi.hashimoto@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Hashimoto |
Organization
University of Tsukuba, Faculty of Medicene
Division name
Clinical and Translational Research Methodology
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
029-853-3064
Homepage URL
koichi.hashimoto@md.tsukuba.ac.jp
Sponsor or person
Institute
Fuculty of Medicine
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Ministry of Agriculture, Forestry and Fisheries
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
1.Takanofoods Co.,Ltd.
2.Industrial technology innovation center of Ibaraki prefecture.
3.National agriculture and food research organization, food research institute.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Ethics Committee of University of Tsukuba Hospital
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
Tel
029-853-3914
chiken@un.tsukuba.ac.jp
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
筑波大学附属病院（茨城県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | Month | 30 | Day |
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
| 2018 | Year | 07 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 08 | Month | 18 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 26 | Day |
Last modified on
| 2020 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038197
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
