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
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
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
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
