UMIN-CTR Clinical Trial

Basic information
Public title	Research on the effect of fructose, sucrose and isomaltulose on uric acid metabolism.
Acronym	Effect of fructose, sucrose and isomaltulose on uric acid metabolism.
Scientific Title	Research on the effect of fructose, sucrose and isomaltulose on uric acid metabolism.
Scientific Title:Acronym	Effect of fructose, sucrose and isomaltulose on uric acid metabolism.
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigated the effects of fructose, sucrose and isomaltulose on uric acid metabolism.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	uric acid levels
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	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of fructose
Interventions/Control_2	Intake of sucrose
Interventions/Control_3	Intake of isomaltulose
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	60 years-old >
Gender	Male and Female
Key inclusion criteria	Those who received a sufficient explanation of the purpose and contents of the study, who have the capacity to consent, voluntarily volunteer with sufficient understanding, and agree to participate in the document.
Key exclusion criteria	1.Those who have allergies of food (fructose, sucrose and isomaltulose 2.Currently, those who undergo medication for hyperuricemia or gout 3.Currently, those who undergo medication for diabetes 4.Those whose HbA1c is higher than 6.5% 5.Those whose fasting blood glucose is higher than 126 mg/dL 6.Those who are pregnant or breastfeeding 7.Those who are smoker 8.Those who judged that the examination director and the test sharing doctor are inappropriate as subjects
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Hidekazu Middle name Last name Arai
Organization	The University of Shizuoka
Division name	Laboratory of Clinical Nutrition and Management, Graduate Division of Nutritional and Environmental Sciences, and Graduate School of Integrated Pharmaceutical and Nutritional Sciences
Zip code	422-8526
Address	52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan
TEL	054-264-5511
Email	arai@u-shizuoka-ken.ac.jp

Public contact
Name of contact person	1st name Hidekazu Middle name Last name Arai
Organization	The University of Shizuoka
Division name	Laboratory of Clinical Nutrition and Management, Graduate Division of Nutritional and Environmental
Zip code	422-8526
Address	52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan
TEL	054-264-5511
Homepage URL
Email	arai@u-shizuoka-ken.ac.jp

Sponsor
Institute	The University of Shizuoka
Institute
Department

Funding Source
Organization	LOTTE FOUNDATION
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The Ethics Committee of the University of Shizuoka
Address	52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan
Tel	054-264-5103
Email	tyous10@u-shizuoka-ken.ac.jp

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	2022 Year 03 Month 09 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	10
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	2020 Year 01 Month 17 Day
Date of IRB	2020 Year 01 Month 17 Day
Anticipated trial start date	2020 Year 02 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 03 Month 08 Day
Last modified on	2022 Year 09 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053746