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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023807
Receipt No. R000027299
Scientific Title Comparative study of Glycemic indices between palm sugar and white sugar in healthy Japanese adults
Date of disclosure of the study information 2016/08/29
Last modified on 2017/03/11

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Basic information
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
Condition Not applicable (healthy adults)
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
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

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

Base
Study type Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute InCROM Inc.
Institute
Department

Funding Source
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

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

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 29 Day

Related information
URL releasing protocol https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000027299
Publication of results Unpublished

Result
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

Progress
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
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.

Management information
Registered date
2016 Year 08 Month 29 Day
Last modified on
2017 Year 03 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027299

Research Plan
Registered date File name
2017/03/06 R000027299_研究計画書_ver 1.pdf

Research case data specifications
Registered date File name
2017/03/06 R000027299_統計解析計画書_v1.0.pdf

Research case data
Registered date File name
2017/03/06 R000027299_統計解析報告書_v1.0.pdf


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