None listed
Conditions
Interventions
Dietary Supplement : Active ingredient: Treatment group – Phaeodactylum powder (fucoxanthin) / Placebo group – Maltodextrin powder
Appearance and formulation: Greenish-brown powder
Content: Treatment
Sponsors
Kyung Hee University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) A person aged 20 or older and under 70 years of age 2) Those with body mass index (BMI) greater than 23 kg/m² and less than 30 kg/m². 3) A person who has agreed to participate in this human body application test before the commencement of the human body application test and has written a written consent form
Exclusion criteria
Exclusion criteria: 1. A person who is currently receiving treatment for severe diseases of the cardiovascular, immune, respiratory, gastrointestinal (including liver and biliary), renal and urinary, nervous, musculoskeletal, or psychiatric systems, or for infectious diseases or malignancies. 2. 2. A person who has used any of the following drugs or health functional foods within 1 month (30 days) prior to Visit 1(Obesity drugs: food intake inhibitors, fat absorption inhibitors, GLP-1 receptor agonists, etc., psychiatric drugs such as depression and schizophrenia, contraceptives, steroids, hormone(sexual hormones), Health functional foods/supplements and herbal medicines for weight control purposes) 3. A person who has initiated treatment with beta-blockers or diuretics within 6 months prior to Visit 1, or for whom a dosage change of beta-blockers or diuretics is expected during the study period (However, participation is permitted if the medication has been administered at a stable dose for more than 6 months prior to Visit 1.) 4. A person with uncontrolled hypertension, defined as systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg, measured after at least 10 minutes of rest 5. A person with poorly controlled diabetes mellitus, defined as glycated hemoglobin (HbA1c) =7.5%, or diabetes that remains uncontrolled despite treatment with antidiabetic medications (including oral hypoglycemic agents or insulin) 6. A person with thyroid-stimulating hormone (TSH) levels =0.1 µU/mL or =10 µU/mL 7. A person whose glomerular filtration rate (GFR) is <45 mL/min 8. A person whose AST(GOT) or ALT(GPT) level exceeds three times the upper limit of normal 9. A person who has difficulty taking the investigational product due to severe gastrointestinal disturbances 10. A person who has alcohol use disorder, substance-induced disorders, or central nervous system disorders 11. A person who is judged to be unable to perform exercise due to musculoskeletal disorders 12. A person who has experienced a body weight change of =10% within 3 months prior to Visit 1 13. A person who has participated in a commercial weight loss program within 3 months prior to Visit 1 14. A person who has participated in another interventional clinical trial (including human application studies) within 1 month (30 days) prior to Visit 1, or who plans to participate in another interventional clinical trial (including human application studies) during the course of this study 15. A person who is pregnant or breastfeeding, or who plans to become pregnant during the course of this human application study 16. A person who has hypersensitivity or allergies to green algae, microalgae, or brown algae–related foods 17. A person who is unlikely to be able to consistently comply with the dietary and exercise instructions and record-keeping provided at Visit 1 18. A person who is deemed unsuitable for participation by the investigator for any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body fat percentage, fat mass through DEXA | — |
Secondary
| Measure | Time frame |
|---|---|
| Body weight;waist circumference, hip circumference, waist/hip circumference ratio;Visceral fat area, subcutaneous fat area, total abdominal fat area, visceral/subcutaneous fat area through CT;Total cholesterol, HDL-cholesterol, LDL-cholesterol, triglyceride, Adiponectin, Leptin, hs-CRP | — |
Countries
Korea, Republic of
Contacts
Public ContactSoyoung Park
Kyung Hee University Hospital
Outcome results
None listed