Beneficial Impact of Orange Juice Consumption on Risk Factors Associated With Cardiovascular Diseases
Condition: Cardiovascular Risk Factors
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 3

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.
    

Detailed 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.
    

Intervention name(s): Control; 100% Florida OJ; 100% Florida OJ-enriched
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 500 mL (250 mL; 2 times/day) of placebo drink for 12 weeks; 500 mL (250 mL; 2 times/day) of 100% Florida OJ for 12 weeks; 500 mL (250 mL; 2 times/day) of 100% Florida OJ-enriched for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Cardiovascular disease; biomarkers; transcriptomics; orange juice; hesperidin; systolic blood pressure; metabolomics; cardiovascular risk factor