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criskorea@korea.kr
  • Status : Approved
    • First Submitted Date : 2018/04/06
    • Registered Date : 2018/07/13
    • Last Updated Date : 2018/05/18
Background Information
1.Background  
CRIS Registration Number KCT0003002 
Unique Protocol ID CTCF2_2017_Wellnessup 
Public/Brief Title To evaluate detoxification and body fat mass decrease effect and safety of Wellnessup® diet: 4-weeks, Clinical trial 
Scientific Title To evaluate detoxification and body fat mass decrease effect and safety of Wellnessup® diet: 4-weeks, Clinical trial  
Acronym  
MFDS Regulated Study No
IND/IDE Protocol No
Registered at Other Registry No
Healthcare Benefit
Approval Status
 
Institutional Review Board Information
2. Institutional Review Board/Ethics Committee  
Board Approval Status Submitted approval 
Board Approval Number CUH-2017-11-009-003 
Approval Date 2017-12-14 
Institutional Review Board  
- Name Chonbuk National University Hospital Institutional Review Board  
- Address 20, Geonji-ro, Deokjin-gu, Jeonju-si, Jeollabuk-do 
- Telephone 063-250-2154 
Data Monitoring Committee No  
Contact Details
3.Contact Details  
Contact Person for Principal Investigator / Scientific Queries
- Name Soo Wan Chae 
- Title Professor 
- Telephone +82-63-259-3040 
- Affiliation Chonbuk National University Hospital 
- Address 20, Geonji-ro, Deokjin-gu, Jeonju, Jeonbuk, Korea 
Contact Person for Public Queries
- Name Woo Rim Kim 
- Title Researcher 
- Telephone +82-63-259-3052 
- Affiliation Chonbuk National University Hospital 
- Address 20, Geonji-ro, Deokjin-gu, Jeonju, Jeonbuk, Korea 
Contact Person for Updating Information
- Name Woo Rim Kim 
- Title Researcher 
- Telephone +82-63-259-3052 
- Affiliation Chonbuk National University Hospital 
- Address 20, Geonji-ro, Deokjin-gu, Jeonju, Jeonbuk, Korea 
Status
4. Status Status  
Study Site Single
Overall Recruitment Status Active, not recruiting  
Date of First Enrollment 2018-01-09 , Actual
Target Number of Participant 45
Primary Completion Date 2018-02-09 , Actual
Study Completion Date 2018-04-13 , Actual
Recruitment Status by Participating Study Site 1 
- Name of Study Site Chonbuk National University Hospital 
- Recruitment Status Active, not recruiting  
- Date of First Enrollment 2018-01-09 , Actual
Source of Monetary / Material Support 정보
5. Source of Monetary/Material Support  
Source of Monetary/Material Support1 
- Organization Name Chonbuk National University Hospital 
- Organization Type Medical Institute  
- Project ID  
Sponsor Organization
6. Sponsor Organization  
Sponsor Organization 1 
- Organization Name Chonbuk National University Hospital 
- Organization Type Medical Institute  
Study Summary
7. Study Summary  
Lay Summary It compares the variation in the hair harmful element and body fat indicators shown in the 4 weeks Wellnessup diet among women whose weight has increased to that of calorie-adjusted healthy group and normal diet group.
- Primary aims: In women whose weight has increased than normal, according to intake Wellnessup diet for 4-weeks, the changes in the hair harmful elements are compared to changes in the intake of comparison diet.
- Secondary aims: In women whose weight has increased than normal, according to intake Wellnessup diet for 4-weeks,the changes antropometric (weight, body mass index, body fat mass/percent, lean body mass, hip & waist circumference, wais-hip circumference ratio), lipid profile(total cholestrol, triglyceride, LDL-cholesterol, HDL-cholesterol, Apo A1, Apo B), glucose profile(fasting blood sugar, fasting insulin, HbA1c, HOMA-IR), inflamamatory factors (hs-CRP, ESR), uric acid, Vitamin D, GGT, fatty liver, urine organic acid, WHOQOL (The World Health Organization Quality of Life assessment) are compared to changes in the intake of comparison diet.  
Study Design 정보
8. Study Design  
Study Type Interventional Study 
Study Purpose Others (Evaluation of the effects of diet decoding and body fat reduction.)
Phase Not applicable 
Intervention Model Parallel  
Blinding/Masking Open 
Allocation RCT 
Intervention Type Others (Diet)
Intervention Description 1. Wellnessup diet group: Consists of ingredients produced in smart farm. The diet consists of shakes, fruit juice, salads and snack such as nuts bar. It consists of a two-week cycle menu.
- Eat the provided diet for 28 days
2. Calorie-adjusted healthy diet group: The dietary composition is the same as that of the Wellnessup diet group. However, materials were purchased from the market rather than from smart farms.
- Eat the provided diet for 28 days
3. Normal diet group: Eat daily meals that have no calorie restriction for 29 days.  
Number of Arms
Arm 1 Arm Label Wellnessu diet group 
Target Number of Participant 15 
Arm Type Experimental 
Arm Description Eat Wellnessup diet that are served four times a day (breakfast, lunch, dinner, snack) for 28 days. 
Arm 2 Arm Label Calorie-adjusted healthy diet group 
Target Number of Participant 15 
Arm Type Placebo comparator 
Arm Description Eat Calorie-adjusted healthy diet that are served four times a day (breakfast, lunch, dinner, snack) for 28 days. 
Arm 3 Arm Label Normal diet group 
Target Number of Participant 15 
Arm Type Active comparator 
Arm Description Eat daily meals that have no calorie restriction for 28 days. 
Subject Eligibility Information
9. Subject  
Condition(s)/Problem(s) * Endocrine, nutritional and metabolic disease
 
Rare Disease No
Inclusion
Criteria
Gender Female 
Age 19 Year ~ 49 Year
Description 1) Women over 19 years old and under 49 years old at the time of screening.
2) A person with a BMI between 23.5 and 30 kg/m2 at the time of screening.
3) The person who has heard and fully understood the full explanation of this human factors testing, and has agreed to voluntarily decide to participate and comply with the cautions.  
Exclusion Criteria 1) A person who has lost more than 10 percent of weight within three months of screening.
2) Who has taken a medication or a health function food product associated with detoxification or weight loss within one month of screening.
3) Severe clinical attention is given to acute or chronic cardiovascular system, endocrinology, immune system, respiratory system, cold blood meter, kidney and urinary system, musculoskeletal system, inflammatory disease, and others.
4) There are people with gastrointestinal conditions (such as Cronic's disease) who can be affected by the human body's applied test, and people with gastro-related operations (except for simple appendix protrusion subtractomization or hernia).
5) Those who overreact about the ingredients in the human diet.
6)Who has continuously administered antipsychotics within six months of screening
7) A suspected drug abuse or medical history
8) Who is constantly drinking alcohol that has exceeded 21 units/week or has a history of alcohol abuse
9) Who shows the following in a diagnostic examination medical examination
☞ Serum AST, ALT > three times of the reference range upper limit
☞ Serum creatinine > 2.0 mg/dL
10) Who has participated in other human body applications within two months of screening
11) Menopause (non-month-free for more than 12 months) or menopause (non-precision for more than three consecutive months) women.
12) A woman who is pregnant or is suckling or has plans to be pregnant during the duration of this human body application testing.
13) Women who became pregnant with pregnancy agreed not to use effective contraception (condoms, birth control masks, intrauterine contraception, or if a male partner underwent vasectomy) during the trial period.
14) A person who has determined that a tester is unsuitable for participating in human factors testing for reasons other than diagnostic testing medical examination results.  
Healthy Volunteers Yes
Outcome Measure(s) Information
10. Outcome Measure(s)  
Type of Primary Outcome Efficacy 
Primary Outcome(s) 1 
- Outcome Analyzed harmfulness element of hair 
- Timepoint 0 week, 4 week 
Secondary Outcome(s) 1 
- Outcome Antropometric(weight, body mass index, body fat mass, percent body fat, lean body mass, waist circumference, hip circumference and waist-hip circumference ratio.) 
- Timepoint Screening, 0 week, 4 week 
Secondary Outcome(s) 2 
- Outcome Lipid profile (Total cholesterol, Triglyceride, LDL-cholestrol, HDL- cholesterol, Apo A1, Apo B) 
- Timepoint 0 week, 4 week 
Secondary Outcome(s) 3 
- Outcome Glucose profile (fasting blood glucose, fasting insulin, HbA1c, HOMA-IR) 
- Timepoint 0 week, 4 week 
Secondary Outcome(s) 4 
- Outcome Inflammatory factors (hs-CRP, ESR) 
- Timepoint 0 week, 4 week 
Secondary Outcome(s) 5 
- Outcome Uric acid 
- Timepoint 0 week, 4 week 
Secondary Outcome(s) 6 
- Outcome Gamma-Glutamyl Transferase (GGT) 
- Timepoint 0 week, 4 week 
Secondary Outcome(s) 7 
- Outcome Vitamin D 
- Timepoint 0 week, 4 week 
Secondary Outcome(s) 8 
- Outcome Fatty liver 
- Timepoint 0 week, 4 week 
Secondary Outcome(s) 9 
- Outcome Urine Organic Acid Test (β-Hydroxybutyrate, Isocitrate, Methylmalonate, α-Ketoisocaprate, α-Hydroxybutyrate (AHB), 3,4-Dihydroxyphenylpropionate (DHPP), 8-Hydroxy-2-deoxyguanosine (8-OHdG)) 
- Timepoint 0 week, 4 week 
Secondary Outcome(s) 10 
- Outcome World Health Organization Quality of Life-BREF 
- Timepoint 0 week, 4 week 
Secondary Outcome(s) 11 
- Outcome subjective/objective adverse event 
- Timepoint 4 week 
Secondary Outcome(s) 12 
- Outcome Results of laboratory test 
- Timepoint Screening, 4 week 
Secondary Outcome(s) 13 
- Outcome Vital sign (systolic/diastolic blood pressure, pulse) 
- Timepoint Screening. 0 week, 4 week 
Study Results and Publication Information
11. Study Results and Publication
Result Registerd No
Sharing of Study Data Information
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement No