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

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Orange Juice (500 mL/d)
Sponsored by
São Paulo State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring Orange juice, Healthy diet, Metabolic syndrome, Cardiometabolic risk factors, Body composition

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Orange juice

    Control

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

    LDL-C
    mg/dL

    Secondary Outcome Measures

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

    Full Information

    First Posted
    September 25, 2017
    Last Updated
    March 30, 2023
    Sponsor
    São Paulo State University
    Collaborators
    National Association of Exporters of Citrus Juices, Citrosuco Company
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03301675
    Brief Title
    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

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2016 (Actual)
    Primary Completion Date
    May 2017 (Actual)
    Study Completion Date
    December 2, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    São Paulo State University
    Collaborators
    National Association of Exporters of Citrus Juices, Citrosuco Company

    4. Oversight

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

    5. 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)
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metabolic Syndrome
    Keywords
    Orange juice, Healthy diet, Metabolic syndrome, Cardiometabolic risk factors, Body composition

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    76 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Orange juice
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Control: Thirty-eight individuals with MetS were submitted to a healthy diet (energy was based on individual actual weight) during 12 weeks.
    Intervention Type
    Other
    Intervention Name(s)
    Orange Juice (500 mL/d)
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    LDL-C
    Description
    mg/dL
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    HDL-C
    Description
    mg/dL
    Time Frame
    12 weeks
    Title
    Glucose
    Description
    mg/dL
    Time Frame
    12 weeks
    Title
    Triglycerides
    Description
    mg/dL
    Time Frame
    12 weeks
    Title
    Waist circunference
    Description
    cm
    Time Frame
    12 weeks
    Title
    Blood pressure systolic and diastolic
    Description
    mm Hg
    Time Frame
    12 weeks
    Title
    Body lean mass
    Description
    kg
    Time Frame
    12 weeks
    Title
    Body fat mass
    Description
    kg
    Time Frame
    12 weeks
    Title
    Body fat
    Description
    percentage
    Time Frame
    12 weeks
    Title
    Visceral fat area
    Description
    kg
    Time Frame
    12 weeks
    Title
    Insulin
    Description
    µU/mL
    Time Frame
    12 weeks
    Title
    Total cholesterol
    Description
    mg/dL
    Time Frame
    12 weeks
    Title
    hsCRP
    Description
    mg/dL
    Time Frame
    12 weeks
    Title
    IL-6
    Description
    pg/ml
    Time Frame
    12 weeks
    Title
    TNF-alfa
    Description
    pg/ml
    Time Frame
    12 weeks
    Title
    ICAM
    Description
    ng/mL
    Time Frame
    12 weeks
    Title
    VCAM
    Description
    ng/mL
    Time Frame
    12 weeks
    Title
    Cardiovascular risk index
    Description
    % risk
    Time Frame
    12 weeks
    Title
    Common carotid artery intima-media thickness - CCA-IMT
    Description
    mm
    Time Frame
    12 weeks
    Title
    Pulse wave velocity - PWV
    Description
    cm/s
    Time Frame
    12 weeks
    Title
    Flow-mediated dilatation of the brachial artery - BA-FMD
    Description
    percentage
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Thais B Cesar, Ph.D.
    Organizational Affiliation
    Sao Paulo State University "Julio de Mesquita Filho", Faculdade de Ciências Farmacêuticas
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26471075
    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.
    Results Reference
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    Effect of Orange Juice and Healthy Diet on Cardiometabolic Risk Factors of Individuals With Metabolic Syndrome

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