A 8 weeks, randomized, double-blind human trial to evaluate the efficacy and safety of Fermented soybean(Cheonggukjang powder) on intestinal microflora and decrease of body fat

Not Applicable

Recruiting

• Conditions: Endocrine, nutritional and metabolic diseases

• Registration Number: KCT0007734
• Lead Sponsor: Wonkwang University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 October 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1) Males and females aged 19 or over and 70 or under at the screening examination
2) Participants whose BMI is 25kg/m^2 or over at the screening examination
3) Participants who have fully understand the information provided about the study voluntarily decided to participate and agree to comply with precautions

Exclusion Criteria

1) Patients who have been taking products influencing body weight(absorption inhibitor and appetite inhibitor, body fat improvement health functional food or the medicine, beta blocker, diuretic, contraceptive, steroid, female hormone agent) within one month before the screening examination (refer to combination prohibition drug)
2) Patients who have undergone obesity surgery within one year
3) Patients who require Patients who have clinically significant acute or chronic cardio-cerebrovascular systems, endocrine systems, immune systems, respiratory systems, hepatic biliary systems, kidneys and urinary systems, neuropsychiatric systems, musculoskeletal systems, inflammatory and hematologic and tumorigenic, gastrointestinal diseases, etc.
4) Those with a history of significant hypersensitivity reactions to soybean and cheonggukjang ingredients
5) Patients who have received antipsychotic medication within three months before screening test
6) Patients who have or are suspected of alcoholism or substance abuse
7) Patients who have participated in other human trials within three months before screening test
8) Patients who are judged ineligible to participate in the trial by the principal investigator for other reasons, including laboratory test outcomes

Study & Design

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

Primary Outcome Measures

Name	Time	Method
changes of intestinal microbiome;Inbody

Secondary Outcome Measures

Name	Time	Method
anthropometric index;lipid metabolism index;body fat-related index;inflammatory index;blood glucose related index;monoenoic fatty acid