UMIN-CTR Clinical Trial

Public title

Comparative study of Glycemic indices between palm sugar and white sugar in healthy Japanese adults

Acronym

Comparative study of GI between palm sugar and white sugar in healthy Japanese adults

Scientific Title

Comparative study of Glycemic indices between palm sugar and white sugar in healthy Japanese adults

Scientific Title:Acronym

Comparative study of GI between palm sugar and white sugar in healthy Japanese adults

Region

Japan

Condition

Not applicable (healthy adults)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To compare Glycemic Indices between palm sugar and white sugar in healthy Japanese adults

Basic objectives2

Others

Basic objectives -Others

Glycemic indices of palm sugar and white sugar

Trial characteristics_1

Confirmatory

Trial characteristics_2

Others

Developmental phase

Not applicable

Primary outcomes

Glycemic Indices of palm sugar and white sugar obtained by glucose (50g/150ml) as a standard

Key secondary outcomes

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

To measure blood glucose levels up to 2 hours following the ingestion of glucose as a standard food to obtain its area under the blood sugar curve (AUC)

Interventions/Control_2

To measure blood glucose levels up to 2 hours following the ingestion of palm sugar (test food), or white sugar (control food) equivalent to 50g of carbohydrate in a 2 arm cross-over design to obtain each Glycemic Index as defined (AUC of palm sugar or white sugar/AUC of glucose x 100)

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

35

years-old

>=

Gender

Male and Female

Key inclusion criteria

1. The subject who was given explanation about the objective, methods, study period, and expected detriment etc. of this study, understood them, and gave informed consent on a voluntary basis.
2. The Japanese healthy male or female subject aged 20 to 35 years, inclusive, at the time of informed consent
3. The subject whose BMI is in the range of 18.5 and over, and less than 25.0
4. The subject who can comply with the study rules and communicate subjective symptoms etc.

Key exclusion criteria

1. The subject who has hepatic, renal, cardiovascular, respiratory, endocrine system, metabolic, neurological, or psychiatric disorder, or who was assessed to have a past history of any of these diseases by the principal investigator or subinvestigators.
2. The subject who presently has or has a past history of allergic symptoms or hypersensitivity.
3. The subject who is allergic to sugar
4. The subject who has drug or alcohol dependence.
5. In addition, the subject who were assessed ineligible for the study by the principal investigator or subinvestigators.

Target sample size

12

Name of lead principal investigator

1st name
Middle name
Last name	Hiroshi Mikami

Organization

Medical Corporation Heishinkai OPHAC Hospital

Division name

Hospital Director

Zip code

Address

4-1-29 Miyahara, Yodogawa-ku, Osaka-shi, Osaka 532-0003, JAPAN

TEL

06-6395-9000

Email

hiroshi.mikami@heishinkai.com

Name of contact person

1st name
Middle name
Last name	Hiroshi Mikami

Organization

Medical Corporation Heishinkai OPHAC Hospital

Division name

Hospital Director

Zip code

Address

4-1-29 Miyahara, Yodogawa-ku, Osaka-shi, Osaka 532-0003, JAPAN

TEL

06-6395-9000

Homepage URL

Email

hiroshi.mikami@heishinkai.com

Institute

InCROM Inc.

Institute

Department

Personal name

Organization

Support Project to Strengthen Commerce and Service Competitiveness for year 2016 (New Cooperation Support Project) by METI(Japan)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

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

医療法人 平心会 大阪治験病院（大阪府）/ Medical Corporation Heishinkai OPHAC Hospital (Osaka Prefecture)

Date of disclosure of the study information

2016

Year

08

Month

29

Day

URL releasing protocol

https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000027299

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

<Results>
The conduct of this study was approved by Medical Corporation Heishinkai OPHAC Hospital ERC, and conducted in accordance with the ethical principles of the Declaration of Helsinki and Ethical Guidelines for Medical and Health Research Involving Human Subjects.
Prior to the initiation of the study, investigators fully explained about the study to all subjects using the informed consent document approved by the ERC and obtained written informed consent on a voluntary basis.
This clinical study started on September 5, 2016 and ended on October 3, 2016.
A total of 14 subjects gave written informed consent, and 12 subjects completed the study excluding 2 subjects who discontinued the study because the baseline value of area under the glucose curve was not obtained. The subjects who completed the study were 6 males and 6 females. The means +/- SDs of age, height, weight and BMI of the subjects were 25.5 +/- 2.9 years, 164.13 +/- 9.73 cm, 56.44 +/- 6.67 kg, and 20.93 +/- 0.88. The GI values of the 12 subjects following palm sugar and white intake were similar. The means +/- SDs of GI values after intake of palm sugar and white sugar were 66.35 +/- 16.64 and 69.97 +/- 34.75, respectively.
No adverse events occurred in this clinical study.
Refer to statistical analysis report for details of statistical analysis 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

2016

Year

08

Month

15

Day

Date of IRB

Anticipated trial start date

2016

Year

09

Month

05

Day

Last follow-up date

2016

Year

10

Month

03

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

2016

Year

12

Month

21

Day

Other related information

<Discussion>
Palm sugar is known as a low GI food containing lots of minerals and raising blood sugar gradually. In this clinical study, GI values of white sugar and those of palm sugar were compared with randomized open-label controlled design by crossover method. GI values were measured in accordance with the Protocol of Japanese Association for the Study of Glycemic Index.
The mean GI value of palm sugar was 66.35, thus palm sugar was considered as a medium GI food (GI value: 55 to 70). GI value of white sugar is commonly described as around 100, however, the mean GI value of white sugar in this study was 69.97, which showed that the GI value of white sugar is also deemed to be a medium GI food.
The study results showed that there were no differences in GI values between palm sugar and white sugar and that both sugars were considered as middle GI value food. The results suggest that palm sugar offers little benefit in terms of food development because they are limited in supply and expensive.
The GI value of white sugar in this study was significantly lower than previously thought. These results suggest necessity to conduct study to precisely compare GI values of various foods including white sugar.
<Conflict of Interest>
This study was conducted by personal funds of InCROM Inc. and partly funded by Support for SMEs New Business Activities in Japan for year 2017 of Small and Medium Enterprise Agency.

Registered date

2016

Year

08

Month

29

Day

Last modified on

2017

Year

03

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027299