Healthy adult
Conditions
Interventions
Consume test food for 8 weeks
Consume placebo food for 8 weeks
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Japanese men and women aged 20 to 65 years old at the time of consent 2. Subjects whose glucose level is between 100 mg per dL and 125 mg per dL as a result of screening test. 3. Subjects who have been fully informed of the purpose and content of the research, have the capacity to consent, have voluntarily volunteered to participate based on a good understanding of the purpose and content of the research, and have agreed to participate in the research in writing.
Exclusion criteria
Exclusion criteria: 1.Subjects with serious renal or hepatic disease, cardiac, respiratory, endocrine, or other metabolic diseases. 2.Subjects with chronic disease and uses pharmaceuticals regularly. 3.Subjects with a history of gastrointestinal surgery (except appendicitis) and gastrointestinal diseases affecting digestion and absorption. 4.As a result of screening test, Subjects with diabetic level (6.5% or higher) of HbA1c (NGSP). 5.Subjects with a BMI of 30 or higher. 6.Subjects with medications that may affect blood glucose levels. 7.Subjects who cannot stop taking supplements or health foods (including foods for specified health uses and foods with functional claims) that may affect blood glucose levels, blood lipids, or body fat during the study period. 8.Subjects with drug or alcohol dependence (a history or present illness). 9.Subjects can't abstain from alcohol for 2 days prior to each examination. 10.Subjects who are determined to be unsuitable by the principal investigator based on blood tests of the screening test. 11.Subjects diagnosed as anemic by screening tests and are not suitable for frequent blood sampling. 12.Subjects with diarrhea within one week prior to the screening test date, or who are normally prone to diarrhea. 13.Subjects donated more than 200 mL of blood or component blood within 1 month or 400 mL within 3 months prior to the date of obtaining consent. 14.Subjects with allergies to ingredients of the studied foods (nuts and fruits). 15.Subjects who are participating, or intend to participate, in research involving the ingestion of other foods or the use of pharmaceuticals, or the application of cosmetics and pharmaceuticals. 16.Pregnant women, women who intend to become pregnant during the study period, women who may become pregnant, and women who are breastfeeding. 17.Other subjects deemed inappropriate as research subjects by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the blood concentration curve (AUC) and change over time, Cmax, delta-Cmax for glucose | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.IAUC and Cmax of the blood insulin levels Cmax, delta-Cmax 2.total cholesterol 3.LDL-cholesterol 4.HDL-cholesterol 5.TG(triglycerides) 6.HbA1c(NGSP) 7.glycoalbumin 8.1,5-AG 9.HOMA-beta 10.GLP-1(activated) 11.8-OHdG(urine) 12.BAP 13.Oxidized-LDL 14.AGEs score:AGEssensor RQ-1201J-SET 15.fundus examination 16.VAS(5 questions) about sleepness 17.POMS(Profile of Mood States)2:full form | — |
Countries
Japan
Contacts
Public ContactMasanori Numazu
KSO Corporation Clinical Trial Management department
Outcome results
None listed