Human study for investigating the effects Chrysanthemum flower extract on body fat level and related metabolism in obese adults

Not Applicable

Not yet recruiting

• Conditions: Endocrine, nutritional and metabolic disease

• Registration Number: KCT0005429
• Lead Sponsor: Ewha Womens University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 5 October 2020

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

1) Subject who voluntarily agree to participate and signs
informed consent form 2) Aged more than 19 years and less than 65 years, women
and men 3) Those with waistlines greater than 90 cm for men and 85 cm for women.
4) Metabolism score is above 1.332 5) Those who can follow the diet and
guidelines during the intervention period

Exclusion Criteria

1) Those who have taken or are likely to take medications
that affect body weight, blood sugar, lipids, hypertension, or intestinal health
within one month of the first visit : appetite suppressants/accelerators,
hormone drugs (female hormones, male hormones, thyroid hormones, steroid drugs,
etc.), TCA drugs, laxatives, antidepressants, hypoglycemic agent, Lipidlowering
drugs, inflammatory bowel disease drug, diuretics, ß-blocker etc. 2) Those who
have taken antibiotics within 2 months of the first visit or are likely to take
it during the study 3) Subject diagnosed with the following diseases ? Liver
dysfunction or hepatobiliary disease ? Renal dysfunction ? Hyperthyroidism and
hypofunction, Cushing's syndrome ? If you have a medical history of severe
central nervous system disorders that require hospitalization or medication ?
Those with severe cerebrovascular disease, heart disease. However, dizziness If
there is no medical history, it may be excluded at the discretion of the
researcher. ? Malignant tumor, lung disease, musculoskeletal disease, immune
system or inflammatory disease ? A person who complains of gastrointestinal
disorders or severe gastrointestinal symptoms such as heartburn, indigestion or
severe constipation 4) Those who have experience in surgery such as gastroplasty
or enterectomy for weight loss 5) Those who have participated in a commercial
obesity program in the past 3 months or have had a calorie-restricted diet
treatment 6) Those who have irregular eating habits and lifestyle 7) Those who
have difficulty complying with dietary and lifestyle guidelines during the study
8) Those who have continuously consumed dietary supplements or herbal medicines
affecting their weight, blood sugar, lipids, and hypertension within one month
of their first visit. 9) Those who have consistently consumed foods, Probiotics
10) Those who have had a weight change of 5% or more within the last 3
months 11) Those who have good quality of usual meals (Recommended Food Score
> 36) 12) Those who continuously exercises high intensity 13) Those who have
hypersensitivity to the test / placebo food or ingredients or have experienced
severe food allergic reactions. 14) Participants in other human application
research within 1 month of first visit 15) Pregnant or lactating women 16) Those
who have difficulty using a smartphone or computer 17) If the researcher deems
inappropriate to participate in this study

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Body fat improvement indicator

Secondary Outcome Measures

Name	Time	Method
Adverse events;Vital signs