Safety study for overdose of galloylated catechins - A randomized double-blind placebo controlled trial

Safety study for overdose of galloylated catechins - A randomized double-blind placebo controlled trial - Safety study for overdose of galloylated catechins - A randomized double-blind placebo controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000052740

Enrollment

Registered

2023-11-09

Start date

2019-05-26

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy subjects

Interventions

The galloylated catechins-containing supplements are taken 3 times a day after each meal for 4 weeks The placebo supplements are taken 3 times a day after each meal for 4 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Age is between 20 to < 65 years old on the date of consent (2)LDL-cholesterol level is 159 mg/dL or less, and BMI is < 30

Exclusion criteria

Exclusion criteria: (1) Current history of serious complications, and suffering from an illness that requires urgent treatment (2)Regular intake of medication for the treatment of chronic illness (3)History of gastrointestinal diseases or surgery that affects digestion and absorption (4)History of drug and/or alcohol addiction (5)Potential to develop allergies against the test food (6)Impossibility to stop the intake of health-promoting foods or quasi-drugs related to lipid metabolism (7)Pregnancy, or desire to become pregnant, currently lactating (8)Diagnosis of familial hyperlipidemia (9)Currently participating in or willing to participate in other clinical studies that take other foods, use medicines, apply cosmetics and drugs, etc. (10)Deemed ineligible to participate by the principal investigator for other reasons

Design outcomes

Primary

Measure	Time frame
(1)Medical interview (2)Body weight and BMI (3)Vital signs (systolic and diastolic blood pressure, pulse rate) (4)Hematological parameters (white blood cell count, red blood cell count, hemoglobin, hematocrit, MCV, MCH, MCHC, platelet count, WBC fractions) (5)Blood biochemical parameters (total protein, albumin, AST (GOT), ALT (GPT), LD (LDH), total bilirubin, ALP, gamma-GT (gamma-GTP), CK (CPK), urea nitrogen (UN), creatinine, uric acid (UA), sodium (Na), chloride (Cl), potassium (K), calcium (Ca), total cholesterol, LDL-cholesterol, HDL-cholesterol, TG(neutral fats), inorganic phosphate, magnesium (Mg), serum iron, fasting blood glucose, HbA1c) (6)Urinalysis (protein qualitative, glucose qualitative, bilirubin qualitative, ketone bodies, urobilinogen qualitative, urinary occult blood, pH, specific gravity) (7)Adverse events.	—

Measure

Time frame

(1)Medical interview (2)Body weight and BMI (3)Vital signs (systolic and diastolic blood pressure, pulse rate) (4)Hematological parameters (white blood cell count, red blood cell count, hemoglobin, hematocrit, MCV, MCH, MCHC, platelet count, WBC fractions) (5)Blood biochemical parameters (total protein, albumin, AST (GOT), ALT (GPT), LD (LDH), total bilirubin, ALP, gamma-GT (gamma-GTP), CK (CPK), urea nitrogen (UN), creatinine, uric acid (UA), sodium (Na), chloride (Cl), potassium (K), calcium (Ca), total cholesterol, LDL-cholesterol, HDL-cholesterol, TG(neutral fats), inorganic phosphate, magnesium (Mg), serum iron, fasting blood glucose, HbA1c) (6)Urinalysis (protein qualitative, glucose qualitative, bilirubin qualitative, ketone bodies, urobilinogen qualitative, urinary occult blood, pH, specific gravity) (7)Adverse events.

—

Countries

Japan

Contacts

Public ContactEiji Yoshikawa

KSO Corporation Sales department

yoshikawa@kso.co.jp03-3452-7733

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026