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
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
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
NCT ID
NCT03301675
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
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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