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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025396
Receipt No. R000029157
Scientific Title Influence of extreme dietary carbohydrate restriction in normal adults as assessed by continuous glucose monitoring-a pilot study
Date of disclosure of the study information 2016/12/26
Last modified on 2016/12/26

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Basic information
Public title Influence of extreme dietary carbohydrate restriction in normal adults as assessed by continuous glucose monitoring-a pilot study
Acronym Influence of extreme dietary carbohydrate restriction in normal adults as assessed by continuous glucose monitoring-a pilot study
Scientific Title Influence of extreme dietary carbohydrate restriction in normal adults as assessed by continuous glucose monitoring-a pilot study
Scientific Title:Acronym Influence of extreme dietary carbohydrate restriction in normal adults as assessed by continuous glucose monitoring-a pilot study
Region
Japan

Condition
Condition Healthy subjects
Classification by specialty
Endocrinology and Metabolism Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigated how extreme carbohydrate restriction for one day affected the blood glucose levels in healthy subjects.
Basic objectives2 Others
Basic objectives -Others The subjects were provided two types of test meal and observed the glucose fluctuations with continuous glucose monitoring (CGM). During the 4 consecutive days, the subjects consumed a normal-carbohydrate (NC) diet on days 1 (D1) and 2 (D2), a low-carbohydrate (LC) diet on day 3 (D3), and the same diet on day 4 (D4) as D1 and D2. The glycemic excursions on the day following intake of a NC diet (D2) were compared with those on the day following intake of the LC diet (D4).
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The mean 24-hr blood glucose level and its standard deviation, the area under the glucose curve (AUC) within 4 hours after each meal, the mean amplitude of the glycemic excursions (MAGE), the incremental AUC of 24-hr blood glucose level above the mean plus one standard deviation (iAUC/MEAN+SD), on D2 and on D4 were calculated.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Subjects fitted with a continuous glucose monitoring device, are given an isoenergetic test meal for 4 consecutive days. On day1, day 2 (D2), and day 4 (D4), they consumed normal-carbohydrate (63-66% carbohydrate) diet, while on day 3, they took low-carbohydrate (5% carbohydrate) diet. The total daily energy intake is 2,200 kcal for males and 1,700 kcal for females.
Interventions/Control_2
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Healthy subjects
Key exclusion criteria Subjects with past diabetes history and any other diseases during treatment are excluded.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koji Kanamori
Organization National center for Global health and Medicine Hospital
Division name Nutrition Management Department
Zip code
Address 1-21-1, Toyama, Shinjuku-ku, Tokyo, 162-8655, Japan
TEL 30-3202-7181
Email kkanamori17160@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noriko Ihana-sugiyama
Organization National center for Global health and Medicine Hospital
Division name Department of Diabetes, Endocrinology and Metabolism
Zip code
Address 1-21-1, Toyama, Shinjuku-ku, Tokyo, 162-8655, Japan
TEL 30-3202-7181
Homepage URL
Email nsugiyama-thk@umin.ac.jp

Sponsor
Institute National Research and Development Agency
Institute
Department

Funding Source
Organization National Research and Development Agency, National center for Global health and Medicine Hoapital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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 12 Month 26 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
2014 Year 11 Month 25 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 10 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
2016 Year 12 Month 26 Day
Last modified on
2016 Year 12 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029157

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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