Postprandial Response of Fresh-squeezed and Processed Orange Juice of Lean and Obese Subjects

NCT ID: NCT03032120

Last Updated: 2017-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2012-11-30

Brief 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 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.

Conditions

Obesity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Fresh orange juice

Intervention: The subjects drank 5 mL/kg body weight of fresh-squeezed orange juice (FOJ).

Group Type: EXPERIMENTAL

Orange juice

Intervention Type: DIETARY_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.

Processed orange juice

Intervention: The subjects drank 5 mL/kg body weight of processed orange juice (POJ).

Group Type: EXPERIMENTAL

Orange juice

Intervention Type: DIETARY_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.

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).

Group Type: EXPERIMENTAL

Control

Intervention Type: DIETARY_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.

Interventions

Orange juice

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.

Intervention Type: DIETARY_SUPPLEMENT

Control

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. Healthy men and women volunteers;

2. Volunteers with BMI between 18.5 to 39.9 kg/m2.

Exclusion Criteria

1. Volunteers with BMI between more than 40 kg/m2;

2. Smokers volunteers;

3. Volunteers who are in treatment with drugs (except contraceptives), vitamins and nutritional supplements;

4. Volunteers who are dieting for weight loss;

5. Volunteers who gained or lost more than 3 kg of weight in the last 3 months;

6. Volunteers who consume more than 20 g of alcohol per day

7. Volunteers who practicing intense physical activity (more than 5 hours per week).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

São Paulo State University

OTHER

Sponsor Role: lead

Responsible Party

Thais Cesar

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Obesity: preventing and managing the global epidemic. Report of a WHO consultation. World Health Organ Tech Rep Ser. 2000;894:i-xii, 1-253.

Reference Type: RESULT

PMID: 11234459 (View on PubMed)

Other Identifiers

SaoPSU17

Identifier Type: -

Identifier Source: org_study_id