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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033528
Receipt No. 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 2019/01/27

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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
Middle name
Last name Koichi Hashimoto
Organization University of Tsukuba, Faculty of Medicene
Division name Clinical and Translational Research Methodology
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL 029-853-3064
Email koichi.hashimoto@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koichi Hashimoto
Organization University of Tsukuba, Faculty of Medicene
Division name Clinical and Translational Research Methodology
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL 029-853-3064
Homepage URL
Email koichi.hashimoto@md.tsukuba.ac.jp

Sponsor
Institute Fuculty of Medicine
University of Tsukuba
Institute
Department

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 institute of Ibaraki prefecture.
3.National agriculture and food research organization, food research institute.
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2019 Year 01 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038197

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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