ObesityNCT03032120
Postprandial Response of Fresh-squeezed and Processed Orange Juice of Lean and Obese Subjects
A study testing Orange juice in people with Obesity, run by São Paulo State University.
Trial summary
This study aimed investigated the acute intake effect of fresh-squeezed orange juice (FOJ), processed orange juice (POJ), and an isoenergetic orange-flavored drink (control) on postprandial response of blood serum biomarkers (glucose, insulin, leptin and adiponectin), anti-oxidatant status, and prospective food intake… Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Orange juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Jul 2012to Nov 2012
- 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 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women volunteers;
- Volunteers with BMI between 18.5 to 39.9 kg/m2.
Who cannot join
- Volunteers with BMI between more than 40 kg/m2;
- Smokers volunteers;
- Volunteers who are in treatment with drugs (except contraceptives), vitamins and nutritional supplements;
- Volunteers who are dieting for weight loss;
- Volunteers who gained or lost more than 3 kg of weight in the last 3 months;
- Volunteers who consume more than 20 g of alcohol per day
- Volunteers who practicing intense physical activity (more than 5 hours per week).
About this study
Official title: Postprandial Response of Fresh-squeezed and Processed Orange Juice on Appetite-related Biomarkers and Antioxidant-status in Lean and Obese Subjects
This study aimed investigated the acute intake effect of fresh-squeezed orange juice (FOJ), processed orange juice (POJ), and an isoenergetic orange-flavored drink (control) on postprandial response of blood serum biomarkers (glucose, insulin, leptin and adiponectin), anti-oxidatant status, and prospective food intake in lean and obese subjects.
Read the detailed description
Non-randomized crossover clinical trial, in which eligible participants (n= 36) were allocated in accordance with their body mass index in two groups, lean (n = 18, 9 women/9 men) and obese (n = 18, 9 women/9 men). Subjects of both groups intake of one single dose (5 mL/kg body weight) of isoenergetic beverages in three different phases: (1) fresh-squeezed orange juice (FOJ), (2) commercial processed orange juice (POJ) and (3) an energy and sugars-matched orange-flavored drink (control), with a washout period of seven days among each beverage. Thirty minutes after the intake of each beverage, the participants had a flavonoid-free standard breakfast, which contained coffee (infusion), milk, sugar or sweetener, white bread sandwich with lean ham and light cream cheese, salted and sweet biscuits. Posteriorly, blood samples (10 mL) were collected at 30, 60, 120 and 300 min after each intervention with a catheter installed in a vein of the arm. After blood collection, the volunteers were instructed to record all meals throughout the day, noting the amount eaten of each food. The sample number took into account variations in blood serum glucose with a type I error α = 0.05 and a type II error β = 0.2 (80% power). Primary output were the modification on glucose or insulin concentration induced by different beverages in some point of the curves. The secondary output was the antioxidant activity induced by FOJ and/or POJ. Kolmogorov Smirnov and Levene test, respectively assessed normality and homogeneity of the data. Area under the curve (AUC0-300 min) was calculated by the clearance of the appetite related-biomarkers (glucose, insulin, leptin and adiponectin) during 300 min for each trial phase Other parameters, as maximum concentration (Cmax), and time to reach maximum blood concentration (Tmax) were also estimated. AUC was determined with the trapezoidal method by Microcal Software Inc., Origin® 6.0. One-way analysis of variance (ANOVA) followed by Sidak post hoc was applied to compared the effect of interventions on appetite related-biomarkers, anti-oxidant status and beverage composition. P significance was set up ≤ 0.05.
- Conditions
- Obesity
- Being tested
- Orange juice, Control
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orange juiceDietary supplement
Lean and obese subjects drank one single dose (5 mL/kg body weight) of fresh-squeezed orange juice (FOJ) and processed orange juice (POJ) followed by an ad libitum breakfast. A washout period of seven days among each beverage (FOJ, POJ and control) was applied.
ControlDietary supplement
Lean and obese subjects drank one single dose (5 mL/kg body weight) of an energy and sugars-matched orange-flavored drink (control), followed by an ad libitum breakfast. A washout period of seven days among each beverage (FOJ, POJ and control) was applied.
| Study group | Role | What they receive |
|---|---|---|
| Fresh orange juice | Experimental | Intervention: The subjects drank 5 mL/kg body weight of fresh-squeezed orange juice (FOJ). Receives: Dietary Supplement: Orange juice |
| Processed orange juice | Experimental | Intervention: The subjects drank 5 mL/kg body weight of processed orange juice (POJ). Receives: Dietary Supplement: Orange juice |
| Control | Experimental | The subjects drank 5 mL/kg body weight of control drink compounded by water mixed with sugars in a similar concentration of orange juices (5.2% of sucrose, 2.5% of fructose, 2.1% of glucose, 0.75% of citric acid, and malic acid 0.25%, flavored and colored with some drops of orange essence). Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the changes on glucose, insulin, leptin, and adiponectin levels over the time times 0, 30, 60, 120, and 300 min
Determination of glucose, insulin, leptin, adiponectin in the blood serum.
Measured: Up to 6 month after blood collection of glucose, insulin, leptin, and adiponectin.
Secondary outcomes (2)
Assessment of the changes on blood serum antioxidant biomarkers before and after each beverage intervention
Determination of TBARS and ABTS in the blood serum.
Measured: Up to 6 month after blood collection of antioxidant biomarkers (TBARS and ABTS).
Assessing of change on prospective food intake after each beverage intervention
Evaluation of prospective food intake by 24-h food recall.
Measured: Up to 3 weeks after the application of each 24-h food recall.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study startJul 2012
- Primary completionNov 2012
- Study completionNov 2012
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 ObesityStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- São Paulo State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thais Cesar, São Paulo State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03032120
- Sponsor's protocol ID
- SaoPSU17
- Status last verified
- Feb 2017
- First submitted
- 16 Jan 2017
- Last updated
- 2 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: There was no plan to share individual participant data (IPD) to other researchers.
Publications
Obesity: preventing and managing the global epidemic. Report of a WHO consultation. World Health Organ Tech Rep Ser. 2000;894:i-xii, 1-253.
PubMed 11234459
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postprandial Response of Fresh-squeezed and Processed Orange Juice on Appetite-related Biomarkers and Antioxidant-status in Lean and Obese Subjects
- ClinicalTrials.gov ID
- NCT03032120
- Acronym / sponsor ID
- SaoPSU17
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- São Paulo State UniversityUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 26 Jan 2017 (estimated)
- 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 investigated the acute intake effect of fresh-squeezed orange juice (FOJ), processed orange juice (POJ), and an isoenergetic orange-flavored drink (control) on postprandial response of blood serum biomarkers (glucose, insulin, leptin and adiponectin), anti-oxidatant status, and prospective food intake in lean and obese subjects.
Detailed description
Non-randomized crossover clinical trial, in which eligible participants (n= 36) were allocated in accordance with their body mass index in two groups, lean (n = 18, 9 women/9 men) and obese (n = 18, 9 women/9 men). Subjects of both groups intake of one single dose (5 mL/kg body weight) of isoenergetic beverages in three different phases: (1) fresh-squeezed orange juice (FOJ), (2) commercial processed orange juice (POJ) and (3) an energy and sugars-matched orange-flavored drink (control), with a washout period of seven days among each beverage. Thirty minutes after the intake of each beverage, the participants had a flavonoid-free standard breakfast, which contained coffee (infusion), milk, sugar or sweetener, white bread sandwich with lean ham and light cream cheese, salted and sweet biscuits. Posteriorly, blood samples (10 mL) were collected at 30, 60, 120 and 300 min after each intervention with a catheter installed in a vein of the arm. After blood collection, the volunteers were instructed to record all meals throughout the day, noting the amount eaten of each food. The sample number took into account variations in blood serum glucose with a type I error α = 0.05 and a type II error β = 0.2 (80% power). Primary output were the modification on glucose or insulin concentration induced by different beverages in some point of the curves. The secondary output was the antioxidant activity induced by FOJ and/or POJ. Kolmogorov Smirnov and Levene test, respectively assessed normality and homogeneity of the data. Area under the curve (AUC0-300 min) was calculated by the clearance of the appetite related-biomarkers (glucose, insulin, leptin and adiponectin) during 300 min for each trial phase Other parameters, as maximum concentration (Cmax), and time to reach maximum blood concentration (Tmax) were also estimated. AUC was determined with the trapezoidal method by Microcal Software Inc., Origin® 6.0. One-way analysis of variance (ANOVA) followed by Sidak post hoc was applied to compared the effect of interventions on appetite related-biomarkers, anti-oxidant status and beverage composition. P significance was set up ≤ 0.05.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fresh orange juice | Experimental | Dietary Supplement: Orange juiceIntervention: The subjects drank 5 mL/kg body weight of fresh-squeezed orange juice (FOJ). |
| Processed orange juice | Experimental | Dietary Supplement: Orange juiceIntervention: The subjects drank 5 mL/kg body weight of processed orange juice (POJ). |
| Control | Experimental | Dietary Supplement: ControlThe subjects drank 5 mL/kg body weight of control drink compounded by water mixed with sugars in a similar concentration of orange juices (5.2% of sucrose, 2.5% of fructose, 2.1% of glucose, 0.75% of citric acid, and malic acid 0.25%, flavored and colored with some drops of orange essence). |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy men and women volunteers;
- Volunteers with BMI between 18.5 to 39.9 kg/m2.
Key exclusion criteria (7 listed)
- Volunteers with BMI between more than 40 kg/m2;
- Smokers volunteers;
- Volunteers who are in treatment with drugs (except contraceptives), vitamins and nutritional supplements;
- Volunteers who are dieting for weight loss;
- Volunteers who gained or lost more than 3 kg of weight in the last 3 months;
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 juiceLean and obese subjects drank one single dose (5 mL/kg body weight) of fresh-squeezed orange juice (FOJ) and processed orange juice (POJ) followed by an ad libitum breakfast. A washout period of seven days among each beverage (FOJ, POJ and control) was applied. | Dietary supplement | Fresh orange juice, Processed orange juice |
| ControlLean and obese subjects drank one single dose (5 mL/kg body weight) of an energy and sugars-matched orange-flavored drink (control), followed by an ad libitum breakfast. A washout period of seven days among each beverage (FOJ, POJ and control) was applied. | Dietary supplement | Control |
Primary outcome
Assessment of the changes on glucose, insulin, leptin, and adiponectin levels over the time times 0, 30, 60, 120, and 300 min
Time frame: Up to 6 month after blood collection of glucose, insulin, leptin, and adiponectin.
Determination of glucose, insulin, leptin, adiponectin in the blood serum.
2 secondary outcomes
Assessment of the changes on blood serum antioxidant biomarkers before and after each beverage intervention
Time frame: Up to 6 month after blood collection of antioxidant biomarkers (TBARS and ABTS).
Assessing of change on prospective food intake after each beverage intervention
Time frame: Up to 3 weeks after the application of each 24-h food recall.
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 2 Feb 2017.
- Results publication: PubMed 11234459Obesity: preventing and managing the global epidemic. Report of a WHO consultation. World Health Organ Tech Rep Ser. 2000;894:i-xii, 1-253.
- Individual participant dataSharing planned: No. There was no plan to share individual participant data (IPD) to other researchers.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Orange juice in people with Obesity, 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 2 inclusion and 7 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 2 Feb 2017. 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?
Assessment of the changes on glucose, insulin, leptin, and adiponectin levels over the time times 0, 30, 60, 120, and 300 min (time frame: Up to 6 month after blood collection of glucose, insulin, leptin, and adiponectin.). 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 NCT03032120, 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 2 Feb 2017.