A randomized, double-blind, placebo-controlled study of effect of green tea on lifestyle-related disease prevention

UMIN ID: UMIN000001722

Registered date:21/02/2009

Basic Information

• Health condition(s) or Problem(s) studied: metabolic syndrome
• Date of first enrollment: 2009/02/01
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Ten capsules of green tea powder, three times a day (6g/day), for 12 weeks.
Ten placebo capsules, three times a day (6g/day), for 12 weeks.

Outcome(s)

• Primary Outcome: 1) body weight 2) HbA1c 3) LDL-cholesterol
• Secondary Outcome: 1) Blood pressure, fat percentage, waist, BMI 2) FBS, insulin 3) Serum total cholesterol, HDL-cholesterol, triglycerides 4) Serum amyloid protein A, high sensitive C_reactive protein 5) Adiponectin, TNF-alfa, urine 8-OHdG

Key inclusion & exclusion criteria

• Age minimum: 30years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1) Individuals with a medical record of heart failure or cardiac infarction. 2) Individuals judged to have atrial fibrillation, Irregular Heart Beat, hepatic damage, kidney damage, cerebrovascular accident, rheumatism, diabetes mellitus, lipid disorder and/or anemia. 3) Individuals with a medical record of allergy to food and drug. 4) Pregnant women, or women with intending to become pregnant, and lactating women. 5) Individuals judged by the doctor to be unsuitable.

Related Information

• Primary Sponsor: Kakegawa Research Council for application of green tea in preventive medicine
• Source(s) of Monetary Support: Kakegawa City