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Effect of Cornus mas L. on Cardiovascular disease in childre

Phase 1
Conditions
dyslipidemia.
Endogenous hyperglyceridaemia Fredrickson's hyperlipoproteinaemia, type IV Hyperlipidaemia, group B Hyperprebetalipoproteinaemia Very-low-density-lipoprotein-type [VLDL] hyperlipoproteinaemia
Registration Number
IRCT201206109662N3
Lead Sponsor
Shahrekord University of Medical Sciences
Brief Summary

Abstract Cornus mas L. (CM) fruits are rich in anthocyanins<br /> and possess both antiinflammatory and antioxidant<br /> activities. The current study was conducted to investigate<br /> whether supplementation with CM could ameliorate lipid<br /> profile and vascular inflammation in dyslipidemic children<br /> and adolescents. In this randomized clinical trial, 40 dyslipidemic<br /> children and adolescents ages 9 to 16 years<br /> were assigned to receive 50 g of CM twice a day after<br /> lunch and dinner (n = 20, case group) or to continue their<br /> normal diet (n = 20, control group). The serum levels of<br /> total cholesterol (TC), low-density lipoprotein cholesterol<br /> (LDL-C), high-density lipoprotein cholesterol (HDL-C),<br /> triglycerides (TG), apo A-I, apo B, intracellular adhesion<br /> molecule-1 (ICAM-1), vascular cell adhesion molecule-1<br /> (VCAM-1), C-reactive protein (CRP), and anthropometric<br /> indices were determined at baseline and then after weeks 3<br /> and 6 of the trial. After week 6 of the trial, the TC, TG,<br /> LDL-C, apo B, ICAM-1, and VCAM-1 levels in the CM<br /> group were significantly lower and the HDL-C and apo A-I<br /> levels higher than at baseline. After week 6 of the trial,<br /> none of these parameters in the control group, except for<br /> ICAM-1, was significantly altered from baseline. However,<br /> between-group comparison showed a significant difference<br /> only for apo A-I (p = 0.016) and a borderline significant<br /> difference for ICAM-1 (p = 0.076). No significant difference<br /> in body mass index, waist-to-hip ratio, or C-reactive<br /> protein was observed between the studied groups. The<br /> present findings revealed a trend toward amelioration of<br /> lipid profile and vascular inflammation following addition<br /> of CM to the daily diet of dyslipidemic children and adolescents<br /> but this needs to be verified by larger scale trials.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
40
Inclusion Criteria

subjects that had at least one of the dyslipidemic measures such as TG (=150 mg/dL), TC (=170 mg/dL), LDL (=130 mg/dL) and low HDL (<35 mg/dL) in serum; dyslipidemic children between the ages of 9-16 years.
Exclusion criteria: known diabetes mellitus; liver disease; nephrotic syndrome; thyroid disorders; chronic pancreatitis; bile duct disorders; the use of medication that would alter lipid metabolism; the informed consent not being signed.

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Total cholesterol. Timepoint: baseline and after the 3 and 6 wk of the treatment. Method of measurement: spectrophotometeric method.;Low-density lipoprotein. Timepoint: baseline and after the 3 and 6 wk of the treatment. Method of measurement: Friedewald formula.;High-density lipoprotein. Timepoint: baseline and after the 3 and 6 wk of the treatment. Method of measurement: spectrophotometeric method.;Triglyceride. Timepoint: baseline and after the 3 and 6 wk of the treatment. Method of measurement: spectrophotometeric method.
Secondary Outcome Measures
NameTimeMethod
WHR. Timepoint: baseline and after the 3 and 6 wk of the treatment. Method of measurement: tape.;BMI. Timepoint: baseline and after the 3 and 6 wk of the treatment. Method of measurement: tape.;VCAM. Timepoint: baseline and after the 3 and 6 wk of the treatment. Method of measurement: ELISA kit.;ICAM. Timepoint: baseline and after the 3 and 6 wk of the treatment. Method of measurement: ELISA kit.;CRP. Timepoint: baseline and after the 3 and 6 wk of the treatment. Method of measurement: automated chemistry analyzer.;Apo A. Timepoint: baseline and after the 3 and 6 wk of the treatment. Method of measurement: automated chemistry analyzer.;Apo B. Timepoint: baseline and after the 3 and 6 wk of the treatment. Method of measurement: automated chemistry analyzer.;HDL/LDL. Timepoint: baseline and after the 3 and 6 wk of the treatment. Method of measurement: spectrophotometeric method.;HDL/TC. Timepoint: baseline and after the 3 and 6 wk of the treatment. Method of measurement: spectrophotometeric method.
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