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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000023726
Receipt No. 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

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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
Institute Juntendo University, Graduate School of Health & Sports Science
Institute
Department

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
URL(English) https://upload.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


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