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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034873
Receipt No. R000038320
Scientific Title The effect of low-carbohydrate diet on blood glucose levels on healthy individuals
Date of disclosure of the study information 2018/11/15
Last modified on 2018/11/16

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Basic information
Public title The effect of low-carbohydrate diet on blood glucose levels on healthy individuals
Acronym The effect of low-carbohydrate diet on bolood glucose levels on healthy individuals
Scientific Title The effect of low-carbohydrate diet on blood glucose levels on healthy individuals
Scientific Title:Acronym The effect of low-carbohydrate diet on bolood glucose levels on healthy individuals
Region
Japan

Condition
Condition healthy volunteer
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to assess the effect of low-carbohydrate diet on blood glucose parameters.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes postprandial glucose values
Key secondary outcomes Area under the curve for glucose

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 High-carbohydrate meal
Participants wear the flash glucose monitoring (FGM) for 8 days. They consume test meals from the fourth to the seventh day, and consume high-carbohydrate diet on the fourth and the sixth day, and consume low-carbohydrate diet on the fifth day. The daily glucose parameters were compared during the 3 study period.
Interventions/Control_2 Low-carbohydrate meal
Participants wear the flash glucose monitoring (FGM) for 8 days. They consume test meals from the fourth to the seventh day, and consume high-carbohydrate diet on the fourth and the sixth day, and consume low-carbohydrate diet on the fifth day. The daily glucose parameters were compared during the 3 study period.
Interventions/Control_3 High-carbohydrate meal 2
Participants wear the flash glucose monitoring (FGM) for 8 days. They consume test meals from the fourth to the seventh day, and consume high-carbohydrate diet on the fourth and the sixth day, and consume low-carbohydrate diet on the fifth day. The daily glucose parameters were compared during the 3 study period.
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
85 years-old >
Gender Male and Female
Key inclusion criteria 1.Healthy volunteers
2.Individuals whose written informed consents have been obtained
3.Individuals who are judged appropriate for the study by the principal
Key exclusion criteria 1.Patients with type 1 and type 2 diabetes
2.Treatment with steroid
3.Women with possibility of pregnancy
4.Severe health problems not suitable for this study
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Imai, Saeko
Organization Kyoto Women's University
Division name Food and Nutrition
Zip code
Address 35, Kitahiyoshi-cho, Imakumano, Higashiyama-ku, Kyoto
TEL 075-531-7128
Email imais@kyoto-wu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Imai, Saeko
Organization Kyoto Women's University
Division name Food and Nutrition
Zip code
Address 35, Kitahiyoshi-cho, Imakumano, Higashiyama-ku, Kyoto
TEL 075-531-7128
Homepage URL
Email imais@kyoto-wu.ac.jp

Sponsor
Institute Kyoto Women's University

Department of Food and Nutrition
Institute
Department

Funding Source
Organization Department of Food and Nutrition
Kyoto Women's University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Kajiyama Clinic, Kyoto
Name of secondary funder(s) Kajiyama Clinic, Kyoto

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 京都女子大学(京都)、梶山内科クリニック(京都)

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 15 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 Preinitiation
Date of protocol fixation
2018 Year 07 Month 10 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 11 Month 13 Day
Last modified on
2018 Year 11 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038320

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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