Efficiency of pharmacologically-active antioxidant phytomedicine Radical Fruits in treatment hypercholesteremia at men.
The purpose of this randomized, double-blind, placebo controlled intervention clinical trial was to investigate the effect of orally administered dietary supplement Radical Fruits (www.gardenoflife.com) consisting of highly concentrated edible fruits and berries on the concentration of plasma cholesterol, urinary 8-epi-prostaglandin F2alpha (8-epi-PGF2alpha) and 11-dehydrothromboxane B2 (11-dehydro-TXB2) in none-obese, non-smoking, non-diabetic hypercholesteremic male volunteers. Forty four (n=44) none-obese, non-smoking, non-diabetic male volunteers with an average age of 40+/-12 years, average body weight of 77,4+/-5,0 kg, average body mass index (BMI) of 22,2+/-2,7 kg/m2 and average total plasma cholesterol level 280+/-22 mg/dL were recruited to take part in a 4 week double-blind, randomized, placebo-controlled clinical trial. After evaluating 12 different antioxidant supplements for their phytochemical compositions and bioavailability, a dietary supplement Radical Fruits was chosen for this clinical trial. Radical Fruits contains standardized extracts and concentrates of prune, pomegranate, apple, grape, raspberry, blueberry, white cherry and strawberry. Subjects were randomly assigned to the treatment group and the placebo group using Simple Randomization Procedure. Subjects in the treatment group (n=22) were directed to take 900 mg of Radical Fruits supplement three times a day before meals. Subjects in the control group (n=22) were directed to take placebo according to the same schedule. Food record analysis, body composition, blood and urine samples were assessed on admission and then once a week. The duration of the clinical trial was 4 weeks. Administration of Radical Fruits(TM) for 4 weeks resulted in statistically significant reduction of total plasma cholesterol from 280+/-23 to 250+/-11 mg/dL, (p<0,001). Total plasma cholesterol changes in the placebo group were not statistically significant. The average plasma LDL was reduced from 195+/-23 to 169+/-21 mg/dL (p<0,001) in the Radical Fruits(TM) group, while in the placebo group there were no statistically significant changes. Plasma HDL increased by 3,2=/-0,6% in the Radical Fruits treated group (p<0,001). No significant changes in the HDL levels were observed in the placebo group. Urinary 8-epi-PGF2alpha level decreased from 450+/-170 to 330+/-159 pg/mg creatinine (p<0,001); urinary 11-dehydro-TXB2 level decreased from 1,200+/-420 to 790+/-320 pg/mg creatinine (p<0,001) with no changes in the placebo group. Administration of pharmacologically active antioxidant supplement Radical Fruit(TM) in hypercholesteremic men significantly increased plasma HDL and reduced total cholesterol and LDL, and urinary oxidative and inflammatory isoprostanes and thromboxane.
Abidov
M
M
Institute of Immunopathology, Center of Modern Medicine, Moscow, Russia.
Jimenez Del Rio
M
M
Ramazanov
A
A
Kalyuzhin
O
O
Chkhikvishvili
I
I
D000328:Adult; D000975:Antioxidants / Q000627:therapeutic use*; D002784:Cholesterol / Q000097:blood; D019587:Dietary Supplements; D004311:Double-Blind Method; D005500:Follow-Up Studies; D005638:Fruit; D006801:Humans; D006937:Hypercholesterolemia / Q000097:blood / Q000188:drug therapy*; D008297:Male; D008517:Phytotherapy / Q000379:methods*; D028321:Plant Preparations / Q000627:therapeutic use*; D016896:Treatment Outcome
D000975:Antioxidants; D028321:Plant Preparations; D002784:Cholesterol