Participants will consume one serving of the test food containing wild rice every day over 28 days.

Healthy Diet

Healthy

30 grams of wild rice in the form salad, snack bar and soup

wild rice

A Multidisciplinary Investigation of Cardiovascular Benefits of Wild Rice

This study is designed to investigate the effects of wild rice consumption on gut microbiome diversity and population in volunteer healthy young adults.

In this study, the investigators will establish whether changes in gut microbiome due to consumption of wild rice may result in altered macronutrient metabolism by studying plasma metabolomics.

In this study, plasma lipoprotein cholesterol concentrations will be estimated to assess the impact of wild rice consumption on the overall risk for atherosclerosis.

Mobil-O-Graph techniques will be used to measure endothelial cell function in the participants prior to consumption of wild rice and after 28 days of consumption of wild rice. This study will establish the effects of wild rice consumption on endothelial cell function.

Mohammed Moghadasian

Principal Investigator

University of Manitoba

after 4 weeks of lifestyle advice and changes, all subjects will receive for 8 weeks the administration of CARDIOVIS COLESTEROLO 3 mg, a nutraceutical compound containing containing red rice fermented with Monascus purpureus titrated with 3% monacolin K, hydrol mixture of olive fruit titrated with vitamin E, Coenzyme Q10 and polymethoxyflavones

Hypercholesterolemia

8-week administration of nutraceutical compound

nutraceutical

University Hospital of Ferrara

Nutraceutical in Cardiovascular Primary Prevention

Nutraceutical Compound to Optimize Cholesterol, Endothelial and Inflammatory Parameters in Subjects With Hypercholesterolemia and Low to Moderate Cardiovascular Risk: the NIRVANA Study

rate of apoptosis in human umbilical vein endothelial cells treated with subject's serum

NO generation in human umbilical vein endothelial cells treated with subject's serum

Gianluca Campo

Associate Professor, Interventional Cardiologist

Subjects that meet the inclusion/exclusion criteria and have provided informed consent will undergo a 4-week period of lifestyle advice and changes. If, after the 4 weeks, LDL values are confirmed above the established cutoffs, the subjects receive CARDIOVIS COLESTEROLO 3 mg for 8 weeks. After the 8-week treatment period, all biological paprameters will be reassessed. Finally, a last blood samples to assess a potential rebound effect after nutraceutical suspension is collected 4 weeks after the treatment stop.

Dyslipidemias

patients will take one tablet of 500mg daily for 12 weeks. No dose titration is foreseen.

Coleosoma

patients will take one tablet daily for 12 weeks.

Placebo

Endocrinology Unit

Efficacy and Tolerability of the Nutraceutical Formulation Coleosoma in Dyslipidemic Subjects

Randomized Controlled Clinical Trial for Assessing Tolerability and Effectiveness of Formula Coleosoma 29 in Patients With Dyslipidemia

Difference in the non-HDL cholesterol value compared to baseline in the 2 arms.

Difference in the Free Plasma Glucose value compared to baseline in the 2 arms.

Difference in the BMI value compared to baseline in the 2 arms.

Difference in the waist circumference value compared to baseline in the 2 arms.

Difference in the HbA1C value compared to baseline in the 2 arms.

Difference in theLDL Cholesterol, triglycerides and HDL cholesterol value compared to baseline in the 2 arms.
All these parameters have the same Units of Measure (mg/dl)

Difference in the ApoB/Apo A1ratio compared to baseline in the 2 arms.

Difference in the inflammatory cytokines value compared to baseline in the 2 arms.
All these parameters have the same Units of Measure (pg/ml)

Difference in the insulin value compared to baseline in the 2 arms.

Difference in the hormone profile compared to baseline in the 2 arms. All these parameters have the same Units of Measure (pg/ml)

Difference in the EPC number compared to baseline in the 2 arms.

Alessandra Dei Cas

Research Assistant, MD, PhD

Azienda Ospedaliero-Universitaria di Parma

DOC generici srl

The study included two arms: a treatment arm with dietary supplement (Coleosoma) and a placebo arm.
Coleosoma is the name of a new patented dietary supplement composed by Berberin 200 mg, Fermented Red Rice from Monascus purpureus 100 mg (correspondiing at 3 mg of monacolin K), Chitosan 100 mg e Q10 Coenzyme10 mg

oryza punctata/zápal

A Multidisciplinary Investigation of Cardiovascular Benefits of Wild Rice

Nutraceutical in Cardiovascular Primary Prevention

Efficacy and Tolerability of the Nutraceutical Formulation Coleosoma in Dyslipidemic Subjects

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