Metabolic SyndromeNCT03301675
Effect of Orange Juice and Healthy Diet on Cardiometabolic Risk Factors of Individuals With Metabolic Syndrome
A study testing Orange Juice (500 mL/d) in people with Metabolic Syndrome, run by São Paulo State University.
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) Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Orange Juice (500 mL/d)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to 2 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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;
Who cannot join
- 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.
About this study
Official title: Effect of Orange Juice Consumption Associated With Healthy Diet on Cardiometabolic Risk Factors of Individuals With Metabolic Syndrome
This study aimed to verify if combination of a healthy diet and orange juice consumption can minimize cardiometabolic risk factors for Metabolic Syndrome (MetS)
Read the 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.
- Conditions
- Metabolic Syndrome
- Being tested
- Orange Juice (500 mL/d)
- Keywords
- Orange juice, Healthy diet, Metabolic syndrome, Cardiometabolic risk factors, Body composition
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orange Juice (500 mL/d)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Orange juice | Experimental | 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. Receives: Other: Orange Juice (500 mL/d) |
| Control | No intervention | Control: Thirty-eight individuals with MetS were submitted to a healthy diet (energy was based on individual actual weight) during 12 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-C
mg/dL
Measured: 12 weeks
Secondary outcomes (20)
HDL-C
mg/dL
Measured: 12 weeks
Glucose
mg/dL
Measured: 12 weeks
Triglycerides
mg/dL
Measured: 12 weeks
Waist circunference
cm
Measured: 12 weeks
Blood pressure systolic and diastolic
mm Hg
Measured: 12 weeks
Body lean mass
kg
Measured: 12 weeks
Body fat mass
kg
Measured: 12 weeks
Body fat
percentage
Measured: 12 weeks
Visceral fat area
kg
Measured: 12 weeks
Insulin
µU/mL
Measured: 12 weeks
Total cholesterol
mg/dL
Measured: 12 weeks
hsCRP
mg/dL
Measured: 12 weeks
IL-6
pg/ml
Measured: 12 weeks
TNF-alfa
pg/ml
Measured: 12 weeks
ICAM
ng/mL
Measured: 12 weeks
VCAM
ng/mL
Measured: 12 weeks
Cardiovascular risk index
% risk
Measured: 12 weeks
Common carotid artery intima-media thickness - CCA-IMT
mm
Measured: 12 weeks
Pulse wave velocity - PWV
cm/s
Measured: 12 weeks
Flow-mediated dilatation of the brachial artery - BA-FMD
percentage
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study startJun 2016
- Primary completionMay 2017
- Study completion2 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- São Paulo State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Association of Exporters of Citrus Juices, Citrosuco Company
- Responsible party
- Principal investigator, Thais Cesar, São Paulo State University
- Investigators
- Thais B Cesar, Ph.D., Principal investigator, Sao Paulo State University "Julio de Mesquita Filho", Faculdade de Ciências Farmacêuticas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03301675
- Sponsor's protocol ID
- SaoPSU8
- Status last verified
- Mar 2023
- First submitted
- 25 Sep 2017
- Last updated
- 3 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 26471075
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Orange Juice Consumption Associated With Healthy Diet on Cardiometabolic Risk Factors of Individuals With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT03301675
- Acronym / sponsor ID
- SaoPSU8
- Conditions
- Metabolic Syndrome
- Keywords
- Orange juice, Healthy diet, Metabolic syndrome, Cardiometabolic risk factors, Body composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- São Paulo State UniversityUniversity, hospital or other
- Collaborators
- National Association of Exporters of Citrus Juices, Citrosuco Company
- Study start
- Jun 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- 2 Dec 2018 (actual)
- First posted
- 4 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orange juice | Experimental | Other: Orange Juice (500 mL/d)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 | No intervention | –Control: Thirty-eight individuals with MetS were submitted to a healthy diet (energy was based on individual actual weight) during 12 weeks. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Orange juice |
Primary outcome
LDL-C
Time frame: 12 weeks
mg/dL
20 secondary outcomes
HDL-C
Time frame: 12 weeks
Glucose
Time frame: 12 weeks
Triglycerides
Time frame: 12 weeks
Waist circunference
Time frame: 12 weeks
Blood pressure systolic and diastolic
Time frame: 12 weeks
Body lean mass
Time frame: 12 weeks
Body fat mass
Time frame: 12 weeks
Body fat
Time frame: 12 weeks
Visceral fat area
Time frame: 12 weeks
Insulin
Time frame: 12 weeks
Total cholesterol
Time frame: 12 weeks
hsCRP
Time frame: 12 weeks
IL-6
Time frame: 12 weeks
TNF-alfa
Time frame: 12 weeks
ICAM
Time frame: 12 weeks
VCAM
Time frame: 12 weeks
Cardiovascular risk index
Time frame: 12 weeks
Common carotid artery intima-media thickness - CCA-IMT
Time frame: 12 weeks
Pulse wave velocity - PWV
Time frame: 12 weeks
Flow-mediated dilatation of the brachial artery - BA-FMD
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
- Background: PubMed 26471075Silveira 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thais B Cesar, Ph.D. principal investigator
Sao Paulo State University "Julio de Mesquita Filho", Faculdade de Ciências Farmacêuticas
Questions about this trial
What is this clinical trial studying?
A study testing Orange Juice (500 mL/d) in people with Metabolic Syndrome, run by São Paulo State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LDL-C (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03301675, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2023.