Effect of Orange Juice and Healthy Diet on Cardiometabolic Risk Factors of Individuals With Metabolic Syndrome

Sponsor

São Paulo State University (Other)

Overall Status

Completed

CT.gov ID

NCT03301675

Collaborator

National Association of Exporters of Citrus Juices (Other), Citrosuco Company (Industry)

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome	Other: Orange Juice (500 mL/d)	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

76 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effect of Orange Juice Consumption Associated With Healthy Diet on Cardiometabolic Risk Factors of Individuals With Metabolic Syndrome

Actual Study Start Date :

Jun 1, 2016

Actual Primary Completion Date :

May 1, 2017

Actual Study Completion Date :

Dec 2, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Orange juice Orange Juice: Thirty-eight individuals with MetS were submitted to a healthy diet (energy was based on individual actual weight) plus 100% orange juice (500 mL/d) during 12 weeks.	Other: Orange Juice (500 mL/d) 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.
No Intervention: Control Control: Thirty-eight individuals with MetS were submitted to a healthy diet (energy was based on individual actual weight) during 12 weeks.

Arm

Intervention/Treatment

Experimental: Orange juice

Orange Juice: Thirty-eight individuals with MetS were submitted to a healthy diet (energy was based on individual actual weight) plus 100% orange juice (500 mL/d) during 12 weeks.

Other: Orange Juice (500 mL/d)

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.

No Intervention: Control

Control: Thirty-eight individuals with MetS were submitted to a healthy diet (energy was based on individual actual weight) during 12 weeks.

Outcome Measures

Primary Outcome Measures

LDL-C [12 weeks]

Secondary Outcome Measures

HDL-C [12 weeks]
Glycaemia [12 weeks]
Triglycerides [12 weeks]
Waist circunference [12 weeks]
Blood pressure [12 weeks]
Body lean mass [12 weeks]
Body fat mass [12 weeks]
% body fat [12 weeks]
Visceral fat area [12 weeks]
Insulin [12 weeks]
HOMA-IR [12 weeks]
Total cholesterol [12 weeks]
Hemoglobin glycated [12 weeks]
hsCRP [12 weeks]
Antioxidant capacity (ABTS) [12 weeks]
Lipid peroxidation (TBARS) [12 weeks]
Adiponectin [12 weeks]
IL-6 [12 weeks]
TNF-alfa [12 weeks]
ICAM [12 weeks]
VCAM [12 weeks]
Cardiovascular risk index [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.