N/A (healthy adults)
Conditions
Interventions
Oral intake of the test product (3 tablets in a day
12 weeks).
Oral intake of the placebo product (3 tablets in a day
12 weeks).
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1]Healthy 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 LDL cholesterol is 120 mg/dl - 139 mg/dl(1). [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. (1)A standard value of LDL cholesterol is a target value and when total number of compatible individuals are less than 40, non-compatible individual(s) will be selected as a subject of the study.
Exclusion criteria
Exclusion criteria: [1]Individuals using medical products. [2]Individuals who are or are under treatment or have a history of hyperlipidemia, and the other serious disorders. [3]Individuals who used a drug to treat in the past 1 month. [4]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, lung disease, or blood disease. [5]Individuals who have a history of digestive organ disease. [6]Individuals whose BMI is over 30. [7]Individuals with serious anemia. [8]Individuals who are sensitive to a test product or other foods, and medical products. [9]Individuals who have a nutritional or exercise guidance by a health care provider. [10]Individuals who are on a diet or have changed an exercise habit in the past 2 months. [11]Individuals who are alcoholism or excessively take alcohol expressed in an amount of alcohol over 60g/day. [12]Individuals whose life style will change during the test period. [13]Individuals who had a habit to ingest foods (ex. health-promoting foods) in the past 3 months or will ingest those foods during the test period. [14]Individuals who have a habit to intake mandarin juice more than 2 times in 1 week. [15]Individuals who had intaken averaged 1 mandarin in 1 week from Oct. 2018 to Mar. 2019. [16]Individuals who regularly intake high beta-cryptoxanthin containing ingredients. [17]Individuals who had a habit to ingest foods (ex. health-promoting foods) which adopt to improve lipid metabolism, liver function, glucose metabolism and body fat in the past 3 months or will ingest those foods during the test period. [18]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. [19]Individuals who are or are possibly pregnant, or are lactating. [20]Individuals who participated in other clinical studies in the past 3 months. [21]Individuals who are or whose family is an employee of a health food company. [22]Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [1]LDL-cholesterol (Screening, Week 6, Week 12). | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary outcomes [1]Indexes for lipid metabolism (Triglyceride, total cholesterol, HDL cholesterol, atherogenic index, non-HDL cholesterol) (Screening, Week 6, Week 12). [2]Indexes for liver function (Aspartate aminotransferase, alanine transaminase, gamma-glutamyltransferase) (Screening, Week 6, Week 12). [3]indexes for glucose metabolism (Blood sugar, HbA1c, HOMA-IR) (Screening, Week 6, Week 12). [4]Indexes for body fat (Weight, body fat percentage, BMI, waist girth, hip girth / waist-hip ratio) (Screening, Week 6, Week 12). *Safety [1]Blood pressure, pulsation (Week 0, Week 4, Week 8, Week 12). [2]Hematologic test (Week 0, Week 4, Week 8, Week 12). [3]Blood biochemical test (Week 0, Week 4, Week 8, Week 12). [4]Urine analysis (Week 0, Week 4, Week 8, Week 12). [5]Doctor's questions (Week 0, Week 4, Week 8, Week 12). [6]Subject's diary (From the first day of ingestion of a test material to the last day of the test). *Other index [1]Serum beta-cryptoxanthin level (Screening, Week 12). | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed