UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023726
Receipt number R000027329
Scientific Title Clinical trial to assess the effect of pinitol containing complex on postprandial blood glucose level.
Date of disclosure of the study information 2016/08/26
Last modified on 2020/07/28 09:15:23

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Basic information

Public title

Clinical trial to assess the effect of pinitol containing complex on postprandial blood glucose level.

Acronym

Effect of pinitol on postprandial blood glucose level

Scientific Title

Clinical trial to assess the effect of pinitol containing complex on postprandial blood glucose level.

Scientific Title:Acronym

Effect of pinitol on postprandial blood glucose level

Region

Japan


Condition

Condition

Healthy subject

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the effect of pinitol containing complex on postprandial blood glucose level.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Postprandial blood glucose level upto 2 hours after intake

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

Food

Interventions/Control_1

Sigle oral intake of pinitol containing complex

Interventions/Control_2

Single oral intake of placebo

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

18 years-old <=

Age-upper limit

25 years-old >

Gender

Male and Female

Key inclusion criteria

1.Healthy person aged from 18 to 25 y.
2.Non-athlete

Key exclusion criteria

1. Subjects who is prescribed drug.
2. Subject who is or was with significant cardiovascular, hepatic, renal, pulmonary or metabolic disease.
3. Subjects who has allergy to the investigational dietary supplement ingredient.
4. Subjects who is participating or participated in a clinical research trial that affects glucose metabolism within 3 months.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshio Suzuki

Organization

Juntendo University

Division name

Graduate School of Health and Sports Science

Zip code


Address

1-1, Hiragagakuendai, Inzai, Chiba, 270-1695 Japan

TEL

+81-476-98-1001

Email

yssuzuki@juntendo.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoshio Suzuki

Organization

Juntendo University

Division name

Graduate School of Health and Sports Science

Zip code


Address

1-1, Hiragagakuendai, Inzai, Chiba, 270-1695 Japan

TEL

+81-476-98-1001

Homepage URL


Email

yssuzuki@juntendo.ac.jp


Sponsor or person

Institute

Juntendo University, Graduate School of Health & Sports Science

Institute

Department

Personal name



Funding Source

Organization

Nihon Advanced Agri 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



Other administrative information

Date of disclosure of the study information

2016 Year 08 Month 26 Day


Related information

URL releasing protocol

https://journals.sagepub.com/doi/full/10.1177/1934578X19890816

Publication of results

Published


Result

URL related to results and publications

https://journals.sagepub.com/doi/full/10.1177/1934578X19890816

Number of participants that the trial has enrolled

20

Results

Participants' mean FBG level was 102.6 +/- 8.2 mg/dL. Participants were categorized by their FBG as normal (n = 5; <100 mg/dL) or impaired glucose tolerance (IGT) (n = 15; 100-125 mg/dL). The incremental area under the curve of blood glucose over 120 minutes after the meal was significantly suppressed by pinitol in the IGT group (P < 0.05), but not in the normal group.

Results date posted

2020 Year 07 Month 28 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2019 Year 12 Month 05 Day

Baseline Characteristics

Described as Table 1 in the published article

Participant flow

Described at study design section in the published article

Adverse events

none

Outcome measures

blood glucose, incremental area under the curve of blood glucose

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2016 Year 07 Month 21 Day

Date of IRB

2016 Year 07 Month 21 Day

Anticipated trial start date

2016 Year 08 Month 29 Day

Last follow-up date

2016 Year 09 Month 02 Day

Date of closure to data entry

2016 Year 09 Month 07 Day

Date trial data considered complete

2016 Year 09 Month 07 Day

Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 08 Month 23 Day

Last modified on

2020 Year 07 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027329


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name