Human study evaluating effectiveness and safety of Curezyme-LAC on body fat level and related metabolism in obese adults

Not Applicable

Completed

• Conditions: Endocrine, nutritional and metabolic diseases

• Registration Number: KCT0005095
• Lead Sponsor: Amicogen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-09-29
• Last Update Posted: 20 September 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1) Subject who voluntarily agree to participate and signs informed consent form
2) 40 = age(men and women) < 65
3) 25kg/? = BMI < 33kg/?
4) waist circumference = 90 cm (male), = 85 cm (female)
5) Subject who can comply with diet and exercise guidelines during the arbitration period

Exclusion Criteria

1) Subject who consistently took medications that affect body weight, lipids, blood sugar metabolism, immune and inflammatory reactions, and intestinal health within one month of the first visit or are likely to take them during the study period
2) Subject who has consumed of dietary supplements or oriental medicine affect body weight, lipid, blood sugar metabolism, immune and inflammatory reactions within one month before the first visit
3) Subject who constantly consumed foods (included health functional foods) related to affect Intestinal health before the first visit
4) Subject with following disease: Uncontrolled Hypertension, Liver dysfunction, Renal dysfunction, et al.
5) Participation in commercial obesity program or experience of calorie-restricted theraphy within three months before the first visit
6) Subject who has had a weight change of more than 5% within three months before the first visit
7) Subject with surgical experience (esophagogastroplasty, enterectomy, et al.) for weight loss
8) Subject who constantly exercised high-intensity as usual
9) Participation in other human study within 1 month before the first visit
10) Pregnant and lactating women
11) Subjects with hypersensitivity to test materials
12) Any condition that the principal investigator believes may put the subjects at undue risk

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Body fat mass(Dual Energy X-Ray AbsorptiometryA)

Secondary Outcome Measures

Name	Time	Method
Fat free mass, body fat percent etc.(Dual Energy X-Ray Absorptiometry);abdominal fat area(Computed Tomography );Body measurement;Related Metabolic indicators: blood lipid, glucose etc.;Bowel habits questionnaire;Food retention questionnaire