N/A (healthy adults)
Conditions
Interventions
[1]Oral ingestion of a test food (1 time). [2]Oral ingestion of a challenge diet. [3]Observation. [4]Washout (over 5 days) [5]Oral ingestion of a placebo food. [6]Oral ingestion of a challenge di
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1]Japanese males and females aged 20-64 years. [2]Individuals who are healthy and are not suffered from a chronic malady including skin disease. [3]Individuals whose triglyceride level is high-normal (120-149 mg/dL) or who are mild hyperlipemia (150-199mg/dL). [4]Individuals whose written informed consent has been obtained. [5]Individuals who can visit an inspection facility and be inspected in designated days. [6]Individuals judged appropriate for the study by the principal.
Exclusion criteria
Exclusion criteria: [1]Individuals using medical products. [2]Individuals who are or are under treatment or have a history of hyperlipidemia, hypertension, diabetes, mental disabilities, sleep disorder or the other serious dysfunctions. [3]Individuals who used a drug to treat in the past 1 month (One-shot medicine of a headache, menstrual pain and a cold removes it). [4]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, lung disease, or blood disease. [5]Individuals who have digestive organ disease (disease of an appendix is removed). [6]Individuals whose menstrual period is during the test period and with serious anemia or poor physical condition during the period (only for females). [7]Individuals whose BMI is over 30kg/m2. [8]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. [9]Individuals with serious anemia. [10]Individuals who are difficult to conduct blood collections over time. [11]Individuals who are sensitive to test products or causes severe allergy in a food and medical supplies. [12]Individuals who cannot intake every diet the day before the inspection day or every loading food. [13]Individuals who are based on average alcohol per 1 day and exceeds 60g/day. [14]Individuals whose life style will change during the test period (ex. travel for a long time). [15]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements which adopt to improve lipid metabolism or glucose metabolism in the past 3 months or will ingest those foods during the test period. [16]Individuals who are or are possibly pregnant, or are lactating. [17]Individuals who participated in other clinical studies in the past 3 months. [18]Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [1]Efficacy evaluation (changes, increase and decrease of TG, NEFA, lipoprotein fraction, RLP-C, apoB48 [before ingestion of a challenge diet, and 2, 3, 4, 6 hours after ingestion of a challenge diet; AUC and iAUC of TG, NEFA, lipoprotein fraction, RLP-C, apoB48 [observation period I and II]). | — |
Secondary
| Measure | Time frame |
|---|---|
| *Indexes for safety [1]Blood pressure, pulsation (screening and before ingestion of a challenge diet). [2]Weight, body fat percentage, BMI (screening and before ingestion of a challenge diet) . [3]Doctor's questions (screening, before ingestion of a challenge diet, and 6 hours after ingestion of a challenge diet). [4]Subject's diary (from one day before ingestion of a challenge diet in observation period I to one day before ingestion of a challenge diet in observation period II). *Other indexes [1]Hematologic test (screening). [2]Blood biochemical test (screening). [3]Urine analysis (screening). | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed