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

• ClinicalTrials.gov Identifier: NCT02914249
• Recruitment Status: Completed
• First Posted: September 26, 2016
• Last Update Posted: September 28, 2016
• Sponsor: São Paulo State University
• Collaborators: National Association of Exporters of Citrus Juices; Citrosuco Company
• Information provided by (Responsible Party): Thais Cesar, São Paulo State University

Tracking Information

• First Submitted Date: September 22, 2016
• First Posted Date: September 26, 2016
• Last Update Posted Date: September 28, 2016
• Study Start Date: September 2015
• Actual Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 23, 2016): Body-weight [ Time Frame: 12 weeks ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 23, 2016)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of Low-calorie Diet and Orange Juice on Body Weight and Metabolic Parameters of Obese Subjects
• Official Title: Low-calorie Diet Combined With Orange Juice Results in Weight Loss: Randomized Controlled Trial
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Obesity

Intervention

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).

Study Arms

• 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.
  Intervention: Other: Orange juice (500 mL/d)
• No Intervention: Control
  Control: thirty-nine obese individuals were submitted to a low-caloric diet (500 kcal/d of energy restriction) during 12 weeks.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 23, 2016): 78
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: August 2016
• Actual Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)

Eligibility 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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02914249
• Other Study ID Numbers: SaoPSU1
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Thais Cesar, São Paulo State University
• Original Responsible Party: Thais Cesar, São Paulo State University, Thais Borges Cesar
• Current Study Sponsor: São Paulo State University
• Original Study Sponsor: Same as current

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)

• PRS Account: São Paulo State University
• Verification Date: September 2016