UMIN-CTR Clinical Trial

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
Email	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
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 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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038197