UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041574
Receipt number R000047404
Scientific Title Investigation of the effect of milk chocolate containing fructooligosaccharides on postprandial blood glucose levels.
Date of disclosure of the study information 2020/08/28
Last modified on 2021/12/13 15:51:54

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Basic information

Public title

Investigation of the effect of milk chocolate containing fructooligosaccharides on postprandial blood glucose levels.

Acronym

Investigation of the effect of milk chocolate containing fructooligosaccharides on postprandial blood glucose levels.

Scientific Title

Investigation of the effect of milk chocolate containing fructooligosaccharides on postprandial blood glucose levels.

Scientific Title:Acronym

Investigation of the effect of milk chocolate containing fructooligosaccharides on postprandial blood glucose levels.

Region

Japan


Condition

Condition

Healthy human

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To elucidate lower responses of postprandial glucose and insulin after ingestion of milk chocolate with fructooligosaccharides than those of milk chocolate without fructoligosaccharides.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Difference of area under the curve of blood glucose levels from baseline.

Key secondary outcomes

1.blood glucose levels (measured values, difference from baseline, area under the curve, Cmax, difference of Cmax of blood glucose levels from baseline, Tmax)
2.insulin levels (measured values, difference from baseline, area under the curve, difference of area under the curve of insulin levels from baseline, Cmax, difference of Cmax of insulin levels from baseline ,Tmax)


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

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Test food : ingestion of chocolate containing fructooligosaccharides with plain hot water . > washout > Control food : ingention of chocolate non-containing fructooligosaccharides with plain hot water.

Interventions/Control_2

Control food : ingestion of chocolate non-containing fructooligosaccharides with plain hot water. > washout > Test food : ingention of chocolate containing fructooligosaccharides with plain hot water.

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

30 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Individuals who receive adequate explanation for the purpose and content of this trial and provide written informed consent for participation by their own free will.
2. Men and women over 30 years old.
3.Those with a fasting blood glucose level of less than 126 mg/dL and HbA1c of less than 6.5%.
4.Non smoker.

Key exclusion criteria

1.Individuals with chronic disease medication.
2.Individuals who take medicines that may affect blood glucose metabolism, take foods for specified health use or foods with functional claims, at least 5 days a week.
3.Individuals with food allergies caused by cocoa, dairy ingredients, soy, eggs, wheat, shrimp, crab, peanuts, buckwheat, almonds, oranges, cashews, kiwifruits, walnuts ,sesame, bananas, peaches, apple, and gelatin.
4.Individuals aware of FOS intolerance.
5.Individuals who can not eat 60g of chocolate.
6.Men less than 40 kg and women less than 30 kg in weight.
7.Individuals comprehensively judged by the investigator to have distinct abnormalities in BMI, blood pressure, hematology test values, and biochemical test values in the preliminary test.
8.Individuals who are pregnant or breastfeeding.
9.Individuals who have participated in other clinical trials within one month before obtaining consent to participate in this study, or those who plan to participate in other clinical studies between the acquisition of consent to participate in this study and the end of the second examination.
10.Others who are judged to be inappropriate as subjects by the investigator.

Target sample size

18


Research contact person

Name of lead principal investigator

1st name Kenichi
Middle name
Last name Watanabe

Organization

Niigata Bio-Research Park, Inc

Division name

Advisor

Zip code

9560841

Address

316-2, Higashijima, Akiha-ku, Niigata, 956-0841, Japan

TEL

0250-25-1196

Email

wataken@med.niigata-u.ac.jp


Public contact

Name of contact person

1st name Hiroshi
Middle name
Last name Goto

Organization

Niigata Bio-Research Park, Inc

Division name

Business promotion division

Zip code

9560841

Address

316-2, Higashijima, Akiha-ku, Niigata, 956-0841, Japan

TEL

0250-25-1196

Homepage URL


Email

goto@nbrp.co.jp


Sponsor or person

Institute

Niigata Bio-Research Park, Inc

Institute

Department

Personal name



Funding Source

Organization

Meiji Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

NBRC Research Ethcs Review Committee

Address

316-2, Higashijima, Akiha-uk, Niigata, 956-0841, Japan

Tel

0250-25-1196

Email

nbrp-food-navi@nbrp.co.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



Other administrative information

Date of disclosure of the study information

2020 Year 08 Month 28 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

Completed

Date of protocol fixation

2020 Year 07 Month 20 Day

Date of IRB

2020 Year 07 Month 20 Day

Anticipated trial start date

2020 Year 08 Month 28 Day

Last follow-up date

2020 Year 12 Month 07 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 08 Month 27 Day

Last modified on

2021 Year 12 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047404


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name