UMIN-CTR Clinical Trial

Public title

A study on the effect of rare sugar syrup on blood glucose level : randomized, placebo-controlled, double blind cross-over trial

Acronym

A study on the effect of rare sugar syrup on blood glucose level

Scientific Title

A study on the effect of rare sugar syrup on blood glucose level : randomized, placebo-controlled, double blind cross-over trial

Scientific Title:Acronym

A study on the effect of rare sugar syrup on blood glucose level

Region

Japan

Condition

Healthy adult and borderline

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the effect of rare sugar syrup on blood glucose level

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

AUC of blood glucose and insulin after the test beverage load

Key secondary outcomes

Blood glucose and insulin levels in each time points after the test beverage load

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Intake of rare sugar syrup dissolved in coffee.

Interventions/Control_2

Intake of granulated sugar dissolved in coffee.

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

65

years-old

>

Gender

Male and Female

Key inclusion criteria

(1)Males and females aged 20 to 64 years old
(2) Subjects who possible to take a blood sample repeatedly with the passage of time
(3) Subjects who show the comparatively large increasing value of blood glucose in the participants, after the glucose load test in the preliminary check.
(4) Subjects who can make self-judgment and are voluntarily giving written informed consent.

Key exclusion criteria

(1)These prescreened medicine.
(2)These having Food for Specified Health Uses (FOSHU) and/or health food.
(3)Subjects who have previous medical history and/or current medical history of serious diseases (e.g., diabetes, circulatory organ, liver, kidney, heart and/or digestive organ).
(4)Pregnant women, lactating women, or women who want to get pregnant during the trial period
(5)Heavy alcohol drinker.
(6)Those that have extremely disheveled lifestyle and/or dietary habits.
(7)Subjects who have previous medical history of drug and/or food allergy.
(8)Subjects who have donated over 200 mL of blood and/or blood components within the last one month prior to the current study.
(9)Subjects who have donated over 400 mL of blood and/or blood components within the last tree months prior to the current study.
(10)Subjects who have donated over 400 mL of blood and/or blood components within the last four months prior to the current study.
(11)Subjects who collected blood amount of blood sampling over 1200 mL within the last twelve months prior to the current study and this clinical trial's blood sampling.
(12)Subjects who collected blood amount of blood sampling over 800 mL within the last twelve months prior to the current study and this clinical trial's blood sampling.
(13)Subjects who have donated over 400 mL of blood and/or blood components within the last four months prior to the current study.
(14)Subjects who have been determined ineligible by principal investigator or sub-investigator.

Target sample size

50

Name of lead principal investigator

1st name	Katsuhisa
Middle name
Last name	Sakano

Organization

CPCC Co.,Ltd.

Division name

Clinical Research Planning Department

Zip code

101-0047

Address

4F Chushin Build. 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047 Japan

TEL

03-5297-3112

Email

cpcc-contact@cpcc.co.jp

Name of contact person

1st name	Kazuyoshi
Middle name
Last name	shibata

Organization

CPCC Co.,Ltd.

Division name

Plan Sales Department

Zip code

101-0047

Address

4F Chushin Build. 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047 Japan

TEL

03-5297-3112

Homepage URL

Email

cpcc-contact@cpcc.co.jp

Institute

CPCC Co.,Ltd.

Institute

Department

Personal name

Organization

Matsutani Chemical Industry Co.,Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Institutional Review Board of Chiyoda Paramedical Care Clinic

Address

2F Chushin Build. 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047 Japan

Tel

03-5297-5548

Email

IRB@cpcc.co.jp

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

07

Month

30

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

Results

We investigated the effects of rare sugar syrup (RSS) on the blood glucose response. First, we determined the glycemic index (GI) of RSS in a randomized single-blind crossover study involving 10 healthy subjects (age32.5+/-1.8y), and found that its value was 49. Second, we examined the effects of RSS on the post-prandial glycemic response in a randomized placebo-control, double-blind crossover study involving 50 healthy subjects, some of whom had borderline diabetes (age47.1+/-1.4y). Sucrose, which contains the same amount of glucose as RSS, was used as a control. Sucrose and RSS were dissolved in 150 mL of coffee. Blood was collected at 6 time-points over 120 min. We found that RSS showed a significantly greater reduction in the 120-min AUC of both blood glucose and insulin compared to the control. This study demonstrated that RSS is a low GI sweetener that elicits a significantly lower glycemic response than sucrose in humans. A second study has been approved by the institutional ethics committee, and is registered in the clinical trial registration system UMIN-CTR (UMIN000018120).

(J. Jpn. Soc. Nutr. Food Sci. 70:271-278(2017))

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

2015

Year

06

Month

19

Day

Date of IRB

Anticipated trial start date

2015

Year

06

Month

19

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

06

Month

29

Day

Last modified on

2020

Year

10

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020972