Clinical trial NCT03301675: Effect of Orange Juice and Healthy Diet on Cardiometabolic Risk Factors of Individuals With Metabolic Syndrome
Official title: Effect of Orange Juice Consumption Associated With Healthy Diet on Cardiometabolic Risk Factors of Individuals With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: Orange juice
Healthy diet
Metabolic syndrome
Cardiometabolic risk factors
Body composition
Lead sponsor: São Paulo State University
Sponsor class: OTHER
Collaborators: name: National Association of Exporters of Citrus Juices
name: Citrosuco Company
First posted: 2017-10-04
Enrollment: 76
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to verify if combination of a healthy diet and orange juice consumption can minimize cardiometabolic risk factors for Metabolic Syndrome (MetS)

Detailed description: The clinical study was parallel, controlled, and randomized with metabolic syndrome subjects (ATPIII, AHA / NHLA) aimed at the consumption of an energy-balanced balanced diet for 12 weeks and divided into two groups: Control (n = 38): dietary guidance only; and Orange Juice (n = 38): diet guidance associated with 500 mL / day of 100% whole orange juice. The recruitment process began in June 2016, the intervention was carried out from September 2016 to December 2016, and the data analysis started in January 2016. The sample number took into account variances on LDL-C, with a type I error α = 0.05 and a type II error β = 0.2 (80% power). The minimum sample size should have 32 individuals per group (n = 64). Considering an approximately 15% dropout rate, the final sample size of study was constituted by 38 individuals per group. Primary and secondary endpoints were the reduction of LDL-C and modification of the levels of cardiometabolic risk factors, inflammatory and hemodynamics parameters, respectively. Kolmogorov Smirnov and Levene test assessed normality and homogeneity of data, respectively. T-test was conducted to identify possible differences between OJ and control groups at baseline. A linear mixed-effects model was apply to determine the time effect within and between groups (Sidak post hoc) and P significance was set up ≤ 0.05. The assessment of body composition, metabolic biomarkers and food intake were analyzed over a 12-week intervention.

Eligibility criteria: Inclusion Criteria:

* Three or more of the risk factors of MS: (1) waist circumference man ≥ 102 cm and woman ≥ 88 cm; (2) triglycerides ≥ 150 mg / dL; (3) HDL-C man ≤ 40 mg / dL and woman ≤ 50 mg / dL; (4) blood pressure ≥ 130 / ≥ 85 mm Hg and (5) fasting glucose ≥ 100 mg / dL (common diabetes, high blood pressure);
* 25 ≥ BMI ≤ 39.9 kg / m - overweight to grade II obesity;
* Like to consume orange juice;

Exclusion Criteria:

* Pregnant / nursing;
* Use of vitamins or vitamin-food supplements in the last three months;
* Individuals with diseases that require specific diet recommendations such as diabetes mellitus with insulin therapy and carbohydrate counts, cancer, chronic liver and kidney disease.

Primary outcomes:
measure: LDL-C
timeFrame: 12 weeks
Secondary outcomes:
measure: HDL-C
timeFrame: 12 weeks
measure: Glucose
timeFrame: 12 weeks
measure: Triglycerides
timeFrame: 12 weeks
measure: Waist circunference
timeFrame: 12 weeks
measure: Blood pressure systolic and diastolic
timeFrame: 12 weeks
measure: Body lean mass
timeFrame: 12 weeks
measure: Body fat mass
timeFrame: 12 weeks
measure: Body fat
timeFrame: 12 weeks
measure: Visceral fat area
timeFrame: 12 weeks
measure: Insulin
timeFrame: 12 weeks
measure: Total cholesterol
timeFrame: 12 weeks
measure: hsCRP
timeFrame: 12 weeks
measure: IL-6
timeFrame: 12 weeks
measure: TNF-alfa
timeFrame: 12 weeks
measure: ICAM
timeFrame: 12 weeks
measure: VCAM
timeFrame: 12 weeks
measure: Cardiovascular risk index
timeFrame: 12 weeks
measure: Common carotid artery intima-media thickness - CCA-IMT
timeFrame: 12 weeks
measure: Pulse wave velocity - PWV
timeFrame: 12 weeks
measure: Flow-mediated dilatation of the brachial artery - BA-FMD
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Sao Paulo State University "Julio de Mesquita Filho", Faculdade de Ciências Farmacêuticas
name: Thais B Cesar, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Silveira JQ, Dourado GK, Cesar TB. Red-fleshed sweet orange juice improves the risk factors for metabolic syndrome. Int J Food Sci Nutr. 2015;66(7):830-6. doi: 10.3109/09637486.2015.1093610.