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Trial record 1 of 74 for:    oranges obesity
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Effect of Low-calorie Diet and Orange Juice on Body Weight and Metabolic Parameters of Obese Subjects (LCD-OJ-OBESE)

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ClinicalTrials.gov Identifier: NCT02914249
Recruitment Status : Completed
First Posted : September 26, 2016
Last Update Posted : September 28, 2016
Sponsor:
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  ICMJE September 22, 2016
First Posted Date  ICMJE September 26, 2016
Last Update Posted Date September 28, 2016
Study Start Date  ICMJE September 2015
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2016)
Body-weight [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Low-calorie Diet and Orange Juice on Body Weight and Metabolic Parameters of Obese Subjects
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 23, 2016)
78
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02914249
Other Study ID Numbers  ICMJE SaoPSU1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE 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  ICMJE São Paulo State University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • National Association of Exporters of Citrus Juices
  • Citrosuco Company
Investigators  ICMJE
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP