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History of Changes for Study: NCT02914249
Effect of Low-calorie Diet and Orange Juice on Body Weight and Metabolic Parameters of Obese Subjects (LCD-OJ-OBESE)
Latest version (submitted September 26, 2016) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 23, 2016 None (earliest Version on record)
2 September 26, 2016 Sponsor/Collaborators and Study Status
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Study NCT02914249
Submitted Date:  September 23, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: SaoPSU1
Brief Title: Effect of Low-calorie Diet and Orange Juice on Body Weight and Metabolic Parameters of Obese Subjects (LCD-OJ-OBESE)
Official Title: Low-calorie Diet Combined With Orange Juice Results in Weight Loss: Randomized Controlled Trial
Secondary IDs:
Open or close this module Study Status
Record Verification: September 2016
Overall Status: Completed
Study Start: September 2015
Primary Completion: January 2016 [Actual]
Study Completion: August 2016 [Actual]
First Submitted: September 22, 2016
First Submitted that
Met QC Criteria:
September 23, 2016
First Posted: September 26, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
September 23, 2016
Last Update Posted: September 26, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: São Paulo State University
Responsible Party: Principal Investigator
Investigator: Thais Cesar
Official Title: Thais Borges Cesar
Affiliation: São Paulo State University
Collaborators: National Association of Exporters of Citrus Juices
Citrosuco Company
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: 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.
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.
Open or close this module Conditions
Conditions: Obesity
Keywords: Orange juice
Low-calorie diet
Body composition
Weight-loss
Metabolic biomarkers
Obese
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 78 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
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.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Body-weight
[ Time Frame: 12 weeks ]

Secondary Outcome Measures:
1. Body mass index (BMI)
[ Time Frame: 12 weeks ]

2. Body lean mass
[ Time Frame: 12 weeks ]

3. Body fat mass
[ Time Frame: 12 weeks ]

4. Percentage of body fat
[ Time Frame: 12 weeks ]

5. Ratio waist/hip
[ Time Frame: 12 weeks ]

6. Glucose
[ Time Frame: 12 weeks ]

7. Insulin
[ Time Frame: 12 weeks ]

8. Homeostatic Model assessment of Insulin Resistance
[ Time Frame: 12 weeks ]

9. Total cholesterol
[ Time Frame: 12 weeks ]

10. LDL-cholesterol
[ Time Frame: 12 weeks ]

11. HDL-cholesterol
[ Time Frame: 12 weeks ]

12. Non-HDL-cholesterol
[ Time Frame: 12 weeks ]

13. Triglycerides
[ Time Frame: 12 weeks ]

14. hsCRP
[ Time Frame: 12 weeks ]

15. Alkaline phosphatase
[ Time Frame: 12 weeks ]

16. Aspartate transaminase
[ Time Frame: 12 weeks ]

17. Alanine transaminase
[ Time Frame: 12 weeks ]

18. Gamma-glutamyl transferase
[ Time Frame: 12 weeks ]

19. Antioxidant capacity (ABTS)
[ Time Frame: 12 weeks ]

20. Lipid peroxidation (TBARS)
[ Time Frame: 12 weeks ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 50 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

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).
Open or close this module Contacts/Locations
Study Officials: Thais B Cesar, Ph.D.
Principal Investigator
Sao Paulo State University "Julio de Mesquita Filho" (UNESP)
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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