UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Influence of extreme dietary carbohydrate restriction in normal adults as assessed by continuous glucose monitoring-a pilot study
Title of the study (Brief title)	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	Koji Kanamori
Organization	National center for Global health and Medicine Hospital
Division name	Nutrition Management Department
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	Noriko Ihana-sugiyama
Organization	National center for Global health and Medicine Hospital
Division name	Department of Diabetes, Endocrinology and Metabolism
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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