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

• Sponsor: São Paulo State University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02914249
• Collaborator: National Association of Exporters of Citrus Juices (Other), Citrosuco Company (Industry)
• Enrollment: 78
• Arms: 2
• Duration (Months): 11

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Other: Orange juice (500 mL/d)	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 78 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Low-calorie Diet Combined With Orange Juice Results in Weight Loss: Randomized Controlled Trial
• Study Start Date: Sep 1, 2015
• Actual Primary Completion Date: Jan 1, 2016
• Actual Study Completion Date: Aug 1, 2016

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Body-weight [12 weeks]

Secondary Outcome Measures

1. Body mass index (BMI) [12 weeks]

2. Body lean mass [12 weeks]

3. Body fat mass [12 weeks]

4. Percentage of body fat [12 weeks]

5. Ratio waist/hip [12 weeks]

6. Glucose [12 weeks]

7. Insulin [12 weeks]

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

9. Total cholesterol [12 weeks]

10. LDL-cholesterol [12 weeks]

11. HDL-cholesterol [12 weeks]

12. Non-HDL-cholesterol [12 weeks]

13. Triglycerides [12 weeks]

14. hsCRP [12 weeks]

15. Alkaline phosphatase [12 weeks]

16. Aspartate transaminase [12 weeks]

17. Alanine transaminase [12 weeks]

18. Gamma-glutamyl transferase [12 weeks]

19. Antioxidant capacity (ABTS) [12 weeks]

20. Lipid peroxidation (TBARS) [12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• São Paulo State University
• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Thais Cesar, Principal Investigator, São Paulo State University
• ClinicalTrials.gov Identifier: NCT02914249
• Other Study ID Numbers: SaoPSU1
• First Posted: Sep 26, 2016
• Last Update Posted: Sep 28, 2016
• Last Verified: Sep 1, 2016

• Keywords provided by Thais Cesar, Principal Investigator, São Paulo State University: Orange juice; Low-calorie diet; Body composition; Weight-loss; Metabolic biomarkers; Obese

Study Results

No Results Posted as of Sep 28, 2016