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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03301675
• Other study ID #: SaoPSU8
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: December 2, 2018

Study information

• Verified date: March 2023
• Source: São Paulo State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: December 2, 2018
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
São Paulo State University	Citrosuco Company, National Association of Exporters of Citrus Juices

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL-C	mg/dL	12 weeks
Secondary	HDL-C	mg/dL	12 weeks
Secondary	Glucose	mg/dL	12 weeks
Secondary	Triglycerides	mg/dL	12 weeks
Secondary	Waist circunference	cm	12 weeks
Secondary	Blood pressure systolic and diastolic	mm Hg	12 weeks
Secondary	Body lean mass	kg	12 weeks
Secondary	Body fat mass	kg	12 weeks
Secondary	Body fat	percentage	12 weeks
Secondary	Visceral fat area	kg	12 weeks
Secondary	Insulin	µU/mL	12 weeks
Secondary	Total cholesterol	mg/dL	12 weeks
Secondary	hsCRP	mg/dL	12 weeks
Secondary	IL-6	pg/ml	12 weeks
Secondary	TNF-alfa	pg/ml	12 weeks
Secondary	ICAM	ng/mL	12 weeks
Secondary	VCAM	ng/mL	12 weeks
Secondary	Cardiovascular risk index	% risk	12 weeks
Secondary	Common carotid artery intima-media thickness - CCA-IMT	mm	12 weeks
Secondary	Pulse wave velocity - PWV	cm/s	12 weeks
Secondary	Flow-mediated dilatation of the brachial artery - BA-FMD	percentage	12 weeks