Effect of Low-calorie Diet and Orange Juice on Body Weight and Metabolic Parameters of Obese Subjects (LCD-OJ-OBESE)

Low-calorie Diet Combined With Orange Juice Results in Weight Loss: Randomized Controlled Trial

This study aimed to verify if combination of a low calorie diet and orange juice consumption results in weight loss and ameliorates metabolic obesity-related biomarkers.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Other: Orange juice (500 mL/d)

Detailed Description

Seventy-eight obese subjects aged 36 ± 1 years and BMI of 33 ± 3 kg were randomly divided into two parallel groups: (1) orange juice (n = 39), composed of individuals subjected to a diet low caloric diet and plus intake of 500 ml orange juice; (2) control (n = 39) composed of individuals subjected to a diet low in calories. The recruitment process began in September 2015, the intervention was carried out from October 2015 to January 2016, and the data analysis started in February 2016. The sample number took into account variances on body weight with a type I error α = 0.05 and a type II error β = 0.2 (80% power). The minimum sample size should have 36 individuals per group (n = 72), considering an approximately 15% dropout rate. Thus, the final sample size of study was constituted by 39 individuals per group (n = 78). Primary and secondary endpoints were the reduction of weight and modification of the levels of obesity-related metabolic biomarkers, respectively. Normality and homogeneity of data were tested. 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 (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 Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 30 > BMI < 40 kg/m2

Exclusion Criteria:

• Dieting last year,
• Use of drugs, vitamins and dietary supplements
• Alcohol consumption (> 20 g alcohol/d)
• Intense physical activity (> 5 hours/week).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Orange juice; Orange juice: thirty-nine obese individuals were submitted to a low-caloric diet (500 kcal/d of energy restriction) plus 100% orange juice (500 mL/d) during 12 weeks.	Other: Orange juice (500 mL/d); Nutritionists prescribed a low-calorie diet that was estimated from total energy expenditure (TEE) for each individual minus 500 kcal per day (30% TEE). Both groups had the same diet plan 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 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 collected (monthly); blood samples and dietary questionnaires (every two weeks).
No Intervention: Control; Control: thirty-nine obese individuals were submitted to a low-caloric diet (500 kcal/d of energy restriction) during 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Body-weight	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Total cholesterol	12 weeks
Body mass index (BMI)	12 weeks
Body lean mass	12 weeks
Body fat mass	12 weeks
Percentage of body fat	12 weeks
Ratio waist/hip	12 weeks
Glucose	12 weeks
Insulin	12 weeks
Homeostatic Model assessment of Insulin Resistance	12 weeks
LDL-cholesterol	12 weeks
HDL-cholesterol	12 weeks
Non-HDL-cholesterol	12 weeks
Triglycerides	12 weeks
hsCRP	12 weeks
Alkaline phosphatase	12 weeks
Aspartate transaminase	12 weeks
Alanine transaminase	12 weeks
Gamma-glutamyl transferase	12 weeks
Antioxidant capacity (ABTS)	12 weeks
Lipid peroxidation (TBARS)	12 weeks

Collaborators and Investigators

• Sponsor: São Paulo State University
• Collaborators: National Association of Exporters of Citrus Juices; Citrosuco Company
• Investigators: Principal Investigator: Thais B Cesar, Ph.D., Sao Paulo State University "Julio de Mesquita Filho" (UNESP)

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: September 22, 2016
• First Submitted That Met QC Criteria: September 23, 2016
• First Posted (Estimate): September 26, 2016

Study Record Updates

• Last Update Posted (Estimate): September 28, 2016
• Last Update Submitted That Met QC Criteria: September 26, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Obese; Body composition; Orange juice; Low-calorie diet; Weight-loss; Metabolic biomarkers
• Other Study ID Numbers: SaoPSU1