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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03301675
Recruitment Status : Completed
First Posted : October 4, 2017
Last Update Posted : April 4, 2019
National Association of Exporters of Citrus Juices
Citrosuco Company
Information provided by (Responsible Party):
Thais Cesar, São Paulo State University

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) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : June 2016
Actual Primary Completion Date : May 2017
Actual Study Completion Date : December 2, 2018

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. LDL-C [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. HDL-C [ Time Frame: 12 weeks ]
  2. Glycaemia [ Time Frame: 12 weeks ]
  3. Triglycerides [ Time Frame: 12 weeks ]
  4. Waist circunference [ Time Frame: 12 weeks ]
  5. Blood pressure [ Time Frame: 12 weeks ]
  6. Body lean mass [ Time Frame: 12 weeks ]
  7. Body fat mass [ Time Frame: 12 weeks ]
  8. % body fat [ Time Frame: 12 weeks ]
  9. Visceral fat area [ Time Frame: 12 weeks ]
  10. Insulin [ Time Frame: 12 weeks ]
  11. HOMA-IR [ Time Frame: 12 weeks ]
  12. Total cholesterol [ Time Frame: 12 weeks ]
  13. Hemoglobin glycated [ Time Frame: 12 weeks ]
  14. hsCRP [ Time Frame: 12 weeks ]
  15. Antioxidant capacity (ABTS) [ Time Frame: 12 weeks ]
  16. Lipid peroxidation (TBARS) [ Time Frame: 12 weeks ]
  17. Adiponectin [ Time Frame: 12 weeks ]
  18. IL-6 [ Time Frame: 12 weeks ]
  19. TNF-alfa [ Time Frame: 12 weeks ]
  20. ICAM [ Time Frame: 12 weeks ]
  21. VCAM [ Time Frame: 12 weeks ]
  22. Cardiovascular risk index [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03301675

Sponsors and Collaborators
São Paulo State University
National Association of Exporters of Citrus Juices
Citrosuco Company
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Principal Investigator: Thais B Cesar, Ph.D. Sao Paulo State University "Julio de Mesquita Filho", Faculdade de Ciências Farmacêuticas

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Responsible Party: Thais Cesar, Principal Investigator, São Paulo State University Identifier: NCT03301675     History of Changes
Other Study ID Numbers: SaoPSU8
First Posted: October 4, 2017    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Thais Cesar, São Paulo State University:
Orange juice
Healthy diet
Metabolic syndrome
Cardiometabolic risk factors
Body composition

Additional relevant MeSH terms:
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Metabolic Syndrome
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases