UMIN-CTR Clinical Trial

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

Healthy subjects

Classification by specialty

Endocrinology and Metabolism

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

National Research and Development Agency

Institute

Department

Personal name

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

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

12

Month

26

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2016

Year

12

Month

26

Day

Last modified on

2016

Year

12

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029157