None listed
Conditions
Interventions
Dietary Supplement : 1. Test Food I (Allulose Powder)
1) Main ingredient name: Allulose (containing 99.7% or more of powder/solid content, based on 99.5% purity)
2) Usage and dosage: Take one packet
Sponsors
Samyang
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) A person who is 19 years of age or older and 65 years of age or younger; 2) Those with a body mass index (BMI) of 25 kg/m2 or more and less than 35 kg/m2 in Visit 1 and Visit 2 3) A person who agrees to participate in this human body application test before the human body application test begins and prepares a written consent form.
Exclusion criteria
Exclusion criteria: 1) Persons currently being treated for severe cardiovascular, immune, respiratory, hepatometer, kidney and urinary system, nervous system, musculoskeletal system, mental, infectious diseases, and malignant tumors. 2) A person who uses of weight-affecting drugs (drug inhibitors, fat absorption inhibitors, GLP-1 receptor agonists, depression and schizophrenia, beta-blockers, diuretics, contraceptives, steroids, female hormones), health functional foods/supplements for weight control, herbal medicine, and hyperlipidemia within one month (30 days) of visit 1. 3) Patients with uncontrolled hypertension (systolic blood pressure of 160 mmHg or higher or diastolic blood pressure of 100 mmHg or higher, measured after 10 minutes of rest for those subject to human application tests) 4) Diabetes patients with HbA1c of greater than 6.5% or who are taking anti-diabetic drugs (such as oral hypoglycemic drugs, insulin, etc.). 5) Those with a triglyceride of 500 mg/dL or more 6) ii. Those with a TSH of 0.1 µIU/mL or less, or 10 µIU/mL or more 7) Those with a creatine level of at least twice the normal upper limit of the implementing institution. 8) A person whose AST (GOT) or ALT (GPT) is at least three times the normal upper limit of the operator. 9) A person who has a problem in eating food for human application testing due to severe gastrointestinal disorders; 10) Alcohol use ? Those with induction disorders and central nervous disorders 11) A person who is deemed unable to exercise due to musculoskeletal disorders. 12) A person who has a weight change of 10% or more within 3 months based on visit 1 13) A person who has participated in a commercial obesity program within 3 months of visiting 1 14) A person who has participated in another interventional clinical trial (including the human body application test) within two months of visit 1 or plans to participate in another interventional clinical trial (including the human body application test) after the start of this human body application test 15) A person who is pregnant or who is lactating or has plans to conceive during this human body application test. 16) A person who is sensitive to or allergic to food ingredients for this human body application test 17) Those who have used intestinal agents and antibiotics within two weeks of visit 1 (limited to those who collect feces for fecal mycelium analysis) 18) Those who have consumed probiotics, prebiotics, and lactic acid bacteria products continuously (at least four times a week) within two weeks of visit 1 (limited to those who do collection for fecal mycology analysis)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body Fat Volume and Body Fat Rate through DEXA | — |
Secondary
| Measure | Time frame |
|---|---|
| Weight;Waist circumference, hip circumference, waist/hip circumference ratio;Body mass index (BMI);Fat-free-mass through DEXA;Visceral fat area, subcutaneous fat area, total abdominal fat area, and visceral/subcutaneous fat area ratio through CT;Blood lipids: Total Cholesterol, HDL-Cholesterol, LDL-Cholesterol, Triglyceride;FBS, Insulin, HbA1c;Adiponectin, Leptin | — |
Countries
Korea, Republic of
Contacts
Public ContactIn-Kyung Jeong
Kyung Hee University Hospital at Gangdong
Outcome results
None listed