UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019175
Receipt number R000022153
Scientific Title Double-Blind, Placebo-Controlled, Parallel Group Comparison Study for the Effect of Daily Ingestion of "Sarasara Gold" extract from onions produced in Hokkaido in the Improvement of Glucose Metabolism
Date of disclosure of the study information 2015/09/30
Last modified on 2017/07/21 12:22:30

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Basic information

Public title

Double-Blind, Placebo-Controlled,
Parallel Group Comparison Study for the Effect of Daily Ingestion of
"Sarasara Gold" extract from onions
produced in Hokkaido in the Improvement of Glucose Metabolism

Acronym

The Effect of Daily Ingestion of the Onion Extract on the Improvement of Glucose Metabolism

Scientific Title

Double-Blind, Placebo-Controlled,
Parallel Group Comparison Study for the Effect of Daily Ingestion of
"Sarasara Gold" extract from onions
produced in Hokkaido in the Improvement of Glucose Metabolism

Scientific Title:Acronym

The Effect of Daily Ingestion of the Onion Extract on the Improvement of Glucose Metabolism

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To prove the clinical usefulness for improvement in glucose metabolism by investigating effects of daily ingestion of "Sarasara Gold" onion extract for 8 weeks.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Serum adiponectin at baseline, and at 4 and 8 weeks after ingestion of test meal.

Key secondary outcomes

Fasting blood glucose, HbA1c,
glycoalbumin, 1.5-AG, insulin,
HOMA-IR, body composition (body weight, BMI, body fat percentage and waist circumference), blood pressure at clinic (SBP and DBP), and QOL questionnaire (VAS)


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

Food

Interventions/Control_1

Ingestion of capsules containing the onion extract daily for 8 weeks.

Interventions/Control_2

Ingestion of placebo capsules daily for 8 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

20 years-old <=

Age-upper limit

65 years-old >

Gender

Male and Female

Key inclusion criteria

1. Subjects whose fasting blood glucose or HbA1c is relatively high.
2. Subjects whose BMI is 18.5 or more and less than 35.
3. Subjects whose blood adiponectin level is relatively low (selected from the screening).
4. Subjects who agree to participate in the current study with a written informed consent.

Key exclusion criteria

1. Subjects who are under treatment, medication and life-style advice for diabetes by doctors.
2. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal, endocrine and metabolic disorders and/or affected with an infectious disease which is required to report to the authorities.
3. Subjects who have a major surgical history related to digestive system such as gastrectomy, gastrorrhaphy, enterectomy and/ or other serious gastrointestinal surgeries.
4. Subjects with abnormal blood pressure or hematological data
5. Subjects with serious anemia
6. Pre- or post-menopausal subjects having complaints of obvious physical changes
7. Subjects who are allergic to foods, especially onions and gelatin.
8. Subjects regularly take medicine, functional foods and/or supplements including dietary fiber such as indigestible dextrin etc., and/or polyphenol, etc. which would affect the blood glucose.
9. Heavy smokers, chronic alcohol drinkers and/or subjects with irregular lifestyle.
10. Subjects who donate either 400ml whole blood within 12 weeks or 200ml whole blood within 4 weeks or blood components within 2 weeks prior to screening.
11. Subjects who are pregnant or expected to be pregnant, or lactating during the study.
12. Subjects who participate in other clinical trials within the last one month prior to the current clinical trial.
13. Any other medical reasons judged by the principal investigator.

Target sample size

64


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Prof. Jun NISHIHIRA, M.D., Ph.D.

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

Email

nishihira@do-johodai.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Dir. Prof. Jun NISHIHIRA, M.D., Ph.D.

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


Email

nishihira@do-johodai.ac.jp


Sponsor or person

Institute

Hokkaido Information University

Institute

Department

Personal name



Funding Source

Organization

Amino Up Chemical Co., Ltd.

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


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

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

2015 Year 09 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

Main results already published

Date of protocol fixation

2015 Year 09 Month 30 Day

Date of IRB


Anticipated trial start date

2015 Year 09 Month 30 Day

Last follow-up date

2015 Year 12 Month 12 Day

Date of closure to data entry

2015 Year 12 Month 28 Day

Date trial data considered complete

2016 Year 01 Month 07 Day

Date analysis concluded

2016 Year 03 Month 10 Day


Other

Other related information



Management information

Registered date

2015 Year 09 Month 30 Day

Last modified on

2017 Year 07 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022153


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name