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Efficacy test of D-allulose in human subjects with overweight or obesity

Status Approved

First Submitted Date

2018/06/04
Registered Date

2018/06/23
Last Updated Date

2018/06/21

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0002950
Unique Protocol ID	KNU 2018-0045
Public/Brief Title	Effect of D-allulose on loss of body weight and body fat in subject with overweight or obesity
Scientific Title	Efficacy test of D-allulose in human subjects with overweight or obesity
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	KNU 2018-0045
Approval Date	2018-03-19
Institutional Review Board Name	Kyungpook National University Institutional Review Board
Institutional Review Board Address	80, Daehak-ro, Buk-gu, Daegu
Institutional Review Board Telephone	053-950-7047
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Myung-Sook Choi
Title	Professor
Telephone	+82-53-950-7936
Affiliation	Kyungpook National University
Address	Daehakro 80, Bukgu, Daegu, South Korea
Contact Person for Public Queries
Name	Youngji Han
Title	PhD. Student
Telephone	+82-53-950-7937
Affiliation	Kyungpook National University
Address	Daehakro 80, Bukgu, Daegu, South Korea
Contact Person for Updating Information
Name	Youngji Han
Title	PhD. Student
Telephone	+82-53-950-7937
Affiliation	Kyungpook National University
Address	Daehakro 80, Bukgu, Daegu, South Korea

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Active, not recruiting
Date of First Enrollment	2018-04-25 Actual
Target Number of Participant	100
Primary Completion Date	2018-07-20 , Anticipated
Study Completion Date	2018-08-15 , Anticipated
Name of Study	Kyungpook National University
Recruitment Status	Active, not recruiting
Date of First Enrollment	2018-04-25 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	CJ Cheiljedang
Organization Type	Others
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Kyungpook National University
Organization Type	University

7. Study Summary

Study Summary Information
Lay Summary	Purpose: The aim of this study is to examine the efficacy of D-allulose in subjects with overweight or obesity. Background: Recently, D-allulose have received attention as sugar substitutes. We have already demonstrated that D-allulose improved the obesity using high-fat diet-induced obese in previous study. Method: ■ Subjects: Male & Female, 20-60 yrs, Overweight or Obese ■ Experiment Design: Control, D-allulose (n=50/group) ■ Morningtoring: D-allulose consumption was regularly mornitored every other week by telephone during the entire study period. Total 4 visits were required to complete the trial. (0, 4, 8, 12weeks) ■ Measurement: dietary 24 hours, body composition(DEXA), blood pressure measurement, abdominal fat area, blood biomarkers.

Study Summary Information

Lay Summary

Purpose: The aim of this study is to examine the efficacy of D-allulose in subjects with overweight or obesity. 
Background: Recently, D-allulose have received attention as sugar substitutes. We have already demonstrated that D-allulose improved the obesity using high-fat diet-induced obese in previous study. 
Method: 
■ Subjects: Male & Female, 20-60 yrs, Overweight or Obese 
■ Experiment Design: Control, D-allulose (n=50/group) 
■ Morningtoring: D-allulose consumption was regularly mornitored every other week by telephone during the entire study period. Total 4 visits were required to complete the trial. (0, 4, 8, 12weeks) 
■ Measurement: dietary 24 hours, body composition(DEXA), blood pressure measurement, abdominal fat area, blood biomarkers.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Supportive Care
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Double
Blinded Subject	Subject, Investigator
Allocation	RCT
Intervention Type	Dietary Supplement
Intervention Description	This study was a randomized, double-blinded, placebo-controlled trial to evaluate the anti-obesity effects of D-allulose in overweight and obese subjects with mild metabolic syndrome. Placebo control: Suclalose (0.012g * 2 times/day, 12 weeks) Test group: D-allulose (7g * 2 times/day, 12 weeks)
Number of Arms	2
Arm 1	Arm Label Placebo Control(Suclalose)
	Target Number of Participant 50
	Arm Type Placebo comparator
	Arm Description Suclalose 0.012g*2times/day for 12 weeks
Arm 2	Arm Label D-allulose group
	Target Number of Participant 50
	Arm Type Experimental
	Arm Description D-allulose (7g * 2 times/day, 12 weeks)

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (E00-E90)Endocrine, nutritional and metabolic diseases (E66.9)Obesity, unspecified
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 20Year~60Year
	Description 1. Male and female volunteers aged 20-60 years with out serious disease 2. 23<=BMI 30 (overweight or obese subjects) 3. Signed a clinical experiment agreement
Exclusion Criteria	1. Hypertensive taking diuretic 2. Patient taking oral hypoglycaemic agent or insulin injection 3. Serious cardiac, renal, hepatic, thyroid or cerebrovascular disease 4. Serious cystic or gastrointestinal disease, gout or porphyrias 5. Phychiatric problems such as depressive disorder, schizophrenia , alchol holic, drug intoxication. 6. Using functional food products that may affect the results of this study 7. A history of surgery within 6 months 8. Cancer diagnosis and treatment 9. Asthma or other allergy 10. Drinking frequently 11. Hard to follow the taking expremental material schedule 12. Pregnant or lactancy period 13. Weight loss control in 3-6month 14. Intake of health food or herbal medicine(Han-yak, 한약) for weight loss in 3-6 month 15. Non-eligible subject
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
Outcome	Body fat mass
Timepoint	Base line and after the 4 weeks, 8 weeks and 12 weeks.
Primary Outcome(s) 2
Outcome	Body fat percentage
Timepoint	Base line and after the 4 weeks, 8 weeks and 12 weeks.
Secondary Outcome(s) 1
Outcome	Abdominal fat area
Timepoint	Base line and after 12 weeks

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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