- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03032120
Postprandial Response of Fresh-squeezed and Processed Orange Juice of Lean and Obese Subjects
February 1, 2017 updated by: Thais Cesar, São Paulo State University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 59 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy men and women volunteers;
- Volunteers with BMI between 18.5 to 39.9 kg/m2.
Exclusion criteria:
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fresh orange juice
Intervention: The subjects drank 5 mL/kg body weight of fresh-squeezed orange juice (FOJ).
|
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.
|
Experimental: Processed orange juice
Intervention: The subjects drank 5 mL/kg body weight of processed orange juice (POJ).
|
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.
|
Experimental: Control
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).
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 6 month after blood collection of glucose, insulin, leptin, and adiponectin.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Determination of TBARS and ABTS in the blood serum.
|
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.
|
Evaluation of prospective food intake by 24-h food recall.
|
Up to 3 weeks after the application of each 24-h food recall.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2012
Primary Completion (Actual)
November 1, 2012
Study Completion (Actual)
November 1, 2012
Study Registration Dates
First Submitted
January 16, 2017
First Submitted That Met QC Criteria
January 23, 2017
First Posted (Estimate)
January 26, 2017
Study Record Updates
Last Update Posted (Estimate)
February 2, 2017
Last Update Submitted That Met QC Criteria
February 1, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- SaoPSU17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
There was no plan to share individual participant data (IPD) to other researchers.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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