Healthy subjects
Conditions
Interventions
300 mg of enteric-coated lactoferrin once daily for 8 weeks
Sponsors
Lion Corporation
Genequest Inc. KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ?Those who are between 20 and 65 years of age at the time of obtaining consent to participate in the research. ?Japanese nationals (excluding naturalized citizens or those who have naturalized citizens or foreign nationals up to the second degree of kinship), men and women who are not related by blood (up to the second degree of kinship) within the research subjects. ?BMI of 25 or higher at the time of screening test. ?Abdominal visceral fat area of 80 cm2 or more at the time of screening. ?Those who are able to come to the research institution on the scheduled visit date. ?Those who are able to abstain from alcohol consumption from the day before the screening test and 8 weeks after the intake test. ?Those who have been fully informed of the purpose and content of the research, have the capacity to consent, and who have voluntarily volunteered to participate based on a good understanding of the purpose and content of the research, and who have agreed to participate in the research in writing.
Exclusion criteria
Exclusion criteria: ?Those who are determined to be in the therapeutic area by the interview of the principal investigator and researcher at the time of screening test. ?Those who are scheduled to receive medication or undergo surgery due to a serious illness or injury within one month prior to the start of the research ). ?Those who have a history of serious illness or current illness in the heart, liver, kidney, digestive organs, etc. ?Those who have difficulty in collecting 2 mL of saliva due to Sjogren's syndrome, dry mouth, etc. ?Those who use or consume medicines, supplements or health foods that may affect dyslipidemia, obesity, etc. ?Persons taking medications that suppress salivary secretion. ?Persons who are regularly taking over-the-counter drugs, foods for specified health uses, foods with functional claims, nutritional foods, etc. that may affect the research. ?Pregnant or possibly pregnant or lactating women who may become pregnant during the study period. ?Heavy alcohol drinkers and excessive smokers. ?Persons who have experienced illness or physical discomfort due to blood sampling in the past. ?Have donated or will donate 400 mL blood within 12 weeks, 200 mL blood within 4 weeks, or component blood within 2 weeks prior to the screening test. ?Constipation. ?Those with extremely irregular eating habits. ?Those who have business trips or travel on average 10 days or more per month. ?Persons who have or may have milk allergy. ?Persons who have metal in the CT scan measurement site. ?Persons with implantable medical devices. ?Persons with claustrophobia, skin diseases, or metal allergies. ?Those who have already participated in other studies or will participate in other studies during the period of this study. ?Those who do not agree with the purpose of the explanation of this research conducted beforehand. ?Other subjects who are deemed inappropriate as research subjects by the principal investigator or the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SNPs associated with the effect of lactoferrin intake on abdominal visceral fat area or BMI reduction and model equations for predicting the effect of lactoferrin using these SNPs. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Lifestyle habits associated with the effect of lactoferrin intake on reducing abdominal visceral fat area/BMI and the model equation for predicting the effect using these habits 2) SNPs and lifestyle habits associated with the effect of lactoferrin intake on reducing abdominal visceral fat area/BMI, and the model equation for predicting the effect using these SNPs and lifestyle habits 3) SNPs and lifestyle habits associated with the effect of lactoferrin intake on reducing abdominal subcutaneous fat area/total abdominal fat area, and model equations for predicting effect using these SNPs and lifestyle habits. 4) SNPs associated with the effects of lactoferrin intake on waist circumference/hip circumference/total cholesterol/LDL-cholesterol/HDL-cholesterol/TG (triglycerides)/glucose/systolic blood pressure/ diastolic blood pressure, and the model equations for predicting the effects using these SNPs. 5) Abdominal visceral fat area, abdominal subcutaneous fat area, and total abdominal fat area 6) BMI 7) Waist circumference and hip circumference 8) Total cholesterol, LDL-cholesterol, HDL-cholesterol, TG (triglycerides), and glucose 9) Systolic blood pressure and diastolic blood pressure 10) Body composition | — |
Countries
Japan
Contacts
Public ContactTomoji Ono
LION Corporation Advanced Analytical Science Research Laboratories
Outcome results
None listed