Records View

To evaluate detoxification and body fat mass decrease effect and safety of Wellnessup® diet: 4-weeks, Clinical trial

Status Approved

  • First Submitted Date

    2018/04/06

  • Registered Date

    2018/07/13

  • Last Updated Date

    2018/05/18

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
    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
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    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
    Institutional Review Board Address 20, Geonji-ro, Deokjin-gu, Jeonju-si, Jeollabuk-do
    Institutional Review Board Telephone 063-250-2154
    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 Soo Wan Chae
    Title Professor
    Telephone +82-63-259-3040
    Affiliation Jeonbuk 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 Jeonbuk 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 Jeonbuk National University Hospital
    Address 20, Geonji-ro, Deokjin-gu, Jeonju, Jeonbuk, 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
    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 Jeonbuk National University Hospital
    Recruitment Status Active, not recruiting
    Date of First Enrollment 2018-01-09 ,
  • 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 Jeonbuk National University Hospital
    Organization Type Medical Institute
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Jeonbuk National University Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    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.
  • 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
    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 3
    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.
  • 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

    Female

    Age

    19Year~49Year

    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
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    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
  • 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
화면 최상단으로 이동

TOP

BOTTOM

화면 최하단으로 이동