Obese adult males with abnormalities in glucose metabolism, lipid metabolism, or blood pressure
Conditions
Interventions
Ingestion of fermented dairy products containing lactic acid bacteria and oligosaccharide syrup for 8 weeks
Ingestion of placebo milk and placebo syrup for 8 weeks
Sponsors
KSO Corporation
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Subjects who meet the following criteria in the screening test 1. Age between 20 and 64 years old 2. BMI between 25 and 30 3. One or more of following applies (1) Fasting blood glucose between 100 and 125 mg/dL (2) Non-HDL-cholesterol concentration between 150 and 189 mg/dL (3) Systolic blood pressure between 130 and 159 mmHg and/or diastolic blood pressure between 85 and 99 mmHg
Exclusion criteria
Exclusion criteria: 1. Those taking hypoglycemic agents, lipid-lowering agents, or antihypertensive agents. 2. Those who take functional foods or supplements that affect glucose and lipid metabolism and blood pressure on a daily basis. 3. Those who are suffering from or have a history of serious heart, liver, kidney, or digestive organ diseases. 4. Those who have an implantable medical device such as a cardiac pacemaker or an implantable cardioverter-defibrillator. 5. Subjects with allergies to milk or soybeans. 6. Those who are judged to be unsuitable as subjects based on the results of the medical interview and the contents of the questionnaire, etc. 7. Persons who routinely consume foods containing lactobacilli or bifidobacteria, foods containing non-digestible oligosaccharides, and beverages, or consume a large amount of such foods and beverages. 8. Subjects who are taking antibiotics on a daily basis. 9. Those hose who are judged to be unsuitable as subjects by the investigator's judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasing blood glucose Glycoalbumin Non-HDL-cholesterol Blood pressure In addition to the overall analysis, subgroup analysis will also be performed by dividing subjects according to the presence or absence of abnormal values for each endpoint. | — |
Secondary
| Measure | Time frame |
|---|---|
| HbAlc (NGSP) Serum insulin homeostatis model assesment-insulin resistance (HOMA-IR) Serum triglyceride Serum total cholesterol Serum LDL-cholesterol Serum HDL-cholesterol Plasma incretin levels Plasma cytokine kevels Fecal microbiota Factors related to intestinal environment body fat percentage waist circumference | — |
Countries
Japan
Contacts
Public ContactEiji Yoshikawa
KSO Corporation Clinical Trial Management Department
Outcome results
None listed