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    

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.

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.

Wellnessu diet group

Eat Wellnessup diet that are served four times a day (breakfast, lunch, dinner, snack) for 28 days.

Calorie-adjusted healthy diet group

Eat Calorie-adjusted healthy diet that are served four times a day (breakfast, lunch, dinner, snack) for 28 days.

Normal diet group

Eat daily meals that have no calorie restriction for 28 days.

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.

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.

Analyzed harmfulness element of hair

0 week, 4 week

Antropometric(weight, body mass index, body fat mass, percent body fat, lean body mass, waist circumference, hip circumference and waist-hip circumference ratio.)

Screening, 0 week, 4 week

Lipid profile (Total cholesterol, Triglyceride, LDL-cholestrol, HDL- cholesterol, Apo A1, Apo B)

0 week, 4 week

Glucose profile (fasting blood glucose, fasting insulin, HbA1c, HOMA-IR)

0 week, 4 week

Inflammatory factors (hs-CRP, ESR)

0 week, 4 week

Uric acid

0 week, 4 week

Gamma-Glutamyl Transferase (GGT)

0 week, 4 week

Vitamin  D

0 week, 4 week

Fatty liver

0 week, 4 week

Urine Organic Acid Test (β-Hydroxybutyrate, Isocitrate, Methylmalonate, α-Ketoisocaprate, α-Hydroxybutyrate (AHB), 3,4-Dihydroxyphenylpropionate (DHPP), 8-Hydroxy-2-deoxyguanosine (8-OHdG))

0 week, 4 week

World Health Organization Quality of Life-BREF

0 week, 4 week

subjective/objective adverse event

4 week

Results of laboratory test

Screening, 4 week

Vital sign (systolic/diastolic blood pressure, pulse)

Screening. 0 week, 4 week