Advertisement

Topics

Beneficial Impact of Orange Juice Consumption on Risk Factors Associated With Cardiovascular Diseases

2015-06-25 05:38:25 | BioPortfolio

Summary

The primary aim is to examine both the acute and chronic effects of hesperidin consumption from 100% Florida orange juice in various doses on functional and systemic markers associated with cardiovascular disease (CVD) risks.

Description

The aim of this study is to compare the effect of different doses of hesperidin in 100% Florida orange juice (OJ) when regularly or postprandially consumed on cardiovascular risk markers; in addition, the plausible role and mechanism of the hesperidin will be investigated.

The sample size was calculated using a previously available bibliography using systolic blood pressure (SBP) as the primary outcome measure. A total of 84 subjects per study product group were needed, assuming variance components of approximately 20.0, to detect differences between the three groups (control, orange juice and hesperidin-enriched orange juice (10 mm Hg)) with a bilateral significance level of α=0.05 and a power of 80 %.

The sample size was computed to be sufficient to detect differences between treatment groups regarding the evolution in time of SBP levels. Justification of chosen sample size is based on the clinically meaningful difference assigned to δ=10.0 mm Hg, which is equivalent to a difference of approximately 7.4 % in patients with baseline SBP levels of approximately 135 mm Hg. Thus, a sample of 252 participants can be used for the chronic three arm parallel trial design (84 subjects/arm) and will allow us to detect small but clinically relevant differences between the three groups with statistical robustness and direct interpretation in terms of the chronic treatment effect.

To the acute postprandial tests, the investigators have chosen n=20 subjects per arm according to the most studies that have addressed the metabolic effects of a postprandial intervention have been performed using a very similar number of subjects with statistically good quality results.

The statistical analysis will follow the principles specified in the guidelines of the ICHE9 and CPMP/EWP/908/99 ICHE9 Points to Consider on Multiplicity Issues in Clinical Trials.

The continuous efficacy variables will be analyzed by an ANCOVA (analysis of covariance) with the baseline value as a covariate.

The efficacy outcomes will be determined using the absolute values and absolute differences from the baseline. The efficacy analysis will be performed using the Available Data Only approach. In addition, the analysis of the primary efficacy variable will be performed with the Baseline Observation Carried Forward approach.

A suitable hypothesis test will be applied to the rest of the variables according to the nature of each variable, such as the Fisher exact test for categorical variables, Student's T-test for continuous variables and Mann-Whitney U test for ordinal scale variables.

The statistical tests will be applied with an α=0.05 two-sided significance level. Post-hoc analyses and comparisons between pairs of groups will be done as for exploratory purposes.

In addition, the statistical plan will be transferred to the application form of the electronic data collection report (e-CDR), which allows the improvement of data management, diminishes human errors (according threshold values of each outcome) and, overall, guarantees the maximum exploitation of human data in the context of statistical analysis.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Conditions

Cardiovascular Risk Factors

Intervention

Control, 100% Florida OJ, 100% Florida OJ-enriched

Location

Technological Centre of Nutrition and Health (CTNS)
Reus
Tarragona
Spain
43204

Status

Not yet recruiting

Source

Technological Centre of Nutrition and Health, Spain

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-06-25T05:38:25-0400

Clinical Trials [3017 Associated Clinical Trials listed on BioPortfolio]

Florida Cardiovascular Quality Network

Florida Cardiovascular Quality Network Application of Clinical Decision Support Software Tools at the Point of Care in Patients with Stable Ischemic Heart Disease - a Quality Outcomes Regi...

Florida Center for Brain Tumor Research

The purpose of this research study is to collect and store brain tumor tissue samples for future research. The samples will become part of the University of Florida Brain Tumor Tissue Bank...

Neuropsychological Norms for Ethnically Diverse Florida Elders

The goal of this proposal is to collect normative data from a sample of ethnically diverse Florida elders on a brief, standardized neuropsychological test battery . The norms collected in ...

The Miami Heart Study at Baptist Health South Florida

The Miami Heart Study at Baptist Health will be an observational, longitudinal and prospective cohort study in a target population of 4000 healthy subjects (40-65 years old) consisting of ...

Trial Comparing FCSEMS and Plastic Stents

The research design is a randomized prospective clinical trial comparing Endoscopic ultrasound (EUS) guided drainage of WON using FCSEMS and plastic stents. The trial will be conducted at ...

PubMed Articles [30976 Associated PubMed Articles listed on BioPortfolio]

Regional differences in the impact of the "Stand Your Ground" law in Florida.

In October 2005, Florida relaxed restrictions on the use of lethal force in self-defense with the Florida stand your ground law (SYG). We examined whether and how the impact of the Florida SYG varied ...

Acceptability of oral rapid HIV testing at dental clinics in communities with high HIV prevalence in South Florida.

Expanding HIV screening for populations at risk necessitates testing in nontraditional settings. We assessed HIV testing in dental clinics in South Florida, an urban area with the highest rates of HIV...

Genetic variability of Ganoderma zonatum infecting palms in Florida.

Ganoderma zonatum is a lethal pathogen of palms (Arecaceae) in Florida (USA) because it degrades the wood of the lowest section of the palm trunk. This fungus is widespread throughout Florida, where i...

Perceptions of Zika Virus Risk during 2016 Outbreak, Miami-Dade County, Florida, USA.

We conducted a survey on Zika virus perceptions and behaviors during the 2016 outbreak in Miami-Dade County, Florida, USA. Among women, Zika knowledge was associated with having a bachelor's degree. A...

Microbiota-Host Crosstalk: A Bridge Between Cardiovascular Risk Factors, Diet, and Cardiovascular Disease.

Cardiovascular disease is the leading cause of death and is also a major cause of disability worldwide. Indeed, even in well-treated patients for hypertension or dyslipidemia, there is still a high ca...

Medical and Biotech [MESH] Definitions

State bounded on east by the Atlantic Ocean, on the south by the Gulf of Mexico, on the west by Alabama and on the north by Alabama and Georgia.

Loss of vascular ELASTICITY due to factors such as AGING; and ARTERIOSCLEROSIS. Increased arterial stiffness is one of the RISK FACTORS for many CARDIOVASCULAR DISEASES.

A body of water located at the southeastern corner of North America. It is bordered by the states to the north of Florida, Alabama, Mississippi, Louisiana, Texas; by five Mexican states to the west: Tamaulipas, Veracruz, Tabasco, Campeche, Yucatan; and by Cuba to the southeast.

The area of those states which seceded in 1861 from the union of the United States of America. They include South Carolina, Mississippi, Florida, Alabama, Georgia, Louisiana, Texas, Virginia, Arkansas, North Carolina, and Tennessee.

The relating of causes to the effects they produce. Causes are termed necessary when they must always precede an effect and sufficient when they initiate or produce an effect. Any of several factors may be associated with the potential disease causation or outcome, including predisposing factors, enabling factors, precipitating factors, reinforcing factors, and risk factors.

More From BioPortfolio on "Beneficial Impact of Orange Juice Consumption on Risk Factors Associated With Cardiovascular Diseases"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Cardiology
Cardiology is a specialty of internal medicine.  Cardiac electrophysiology : Study of the electrical properties and conduction diseases of the heart. Echocardiography : The use of ultrasound to study the mechanical function/physics of the h...

Cardiovascular disease (CVD)
Acute Coronary Syndromes (ACS) Blood Cardiovascular Dialysis Hypertension Stent Stroke Vascular Cardiovascular disease (CVD) includes all the diseases of the heart and circulation including coronary heart disease (angina...

Clinical Approvals
Clinical trials are a set of procedures in medical research conducted to allow safety (or more specifically, information about adverse drug reactions and adverse effects of other treatments) and efficacy data to be collected for health interventions (e.g...


Searches Linking to this Trial