Metabolic Syndrome
Conditions
Keywords
Orange juice, Healthy diet, Metabolic syndrome, Cardiometabolic risk factors, Body composition
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.
Interventions
Nutritionists prescribed the same balanced diet for both groups keeping suffice energy to maintain the current weight, estimated from total energy expenditure (TEE) for each individual and based on individual weight. The dietary plan was composed of six meals/day: breakfast (fat-free milk and coffee; whole-grain bread with margarine, and an apple); snack 1 (250 mL OJ/ banana or other fruits and free-fat yogurt); lunch (brown rice, beans, grilled lean meat, salad, cooked vegetables); snack 2 (250 mL OJ / free-fat yogurt with oatmeal); dinner (brown rice, beans, grilled lean meat, cooked vegetables and salad); and snack 3 (salty crackers or oat cookies, tea without sugar). Body composition measurements were colected every two weeks; blood samples and dietary questionnaires, monthly.
Sponsors
National Association of Exporters of Citrus Juices
Citrosuco Company
São Paulo State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LDL-C | 12 weeks | mg/dL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body lean mass | 12 weeks | kg |
| Body fat mass | 12 weeks | kg |
| Body fat | 12 weeks | percentage |
| Visceral fat area | 12 weeks | kg |
| Insulin | 12 weeks | µU/mL |
| Total cholesterol | 12 weeks | mg/dL |
| hsCRP | 12 weeks | mg/dL |
| IL-6 | 12 weeks | pg/ml |
| TNF-alfa | 12 weeks | pg/ml |
| Blood pressure systolic and diastolic | 12 weeks | mm Hg |
| VCAM | 12 weeks | ng/mL |
| Cardiovascular risk index | 12 weeks | % risk |
| Common carotid artery intima-media thickness - CCA-IMT | 12 weeks | mm |
| Pulse wave velocity - PWV | 12 weeks | cm/s |
| Flow-mediated dilatation of the brachial artery - BA-FMD | 12 weeks | percentage |
| HDL-C | 12 weeks | mg/dL |
| Glucose | 12 weeks | mg/dL |
| Triglycerides | 12 weeks | mg/dL |
| Waist circunference | 12 weeks | cm |
| ICAM | 12 weeks | ng/mL |
Outcome results
None listed