An interventional study of Orange juice (500 mL/d) in Obesity, sponsored by São Paulo State University. Completed. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-28.
Sponsored by São Paulo State University · Not applicable, Interventional, and Treatment
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.
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.
6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.
This study's enrollment of 78 is close to the median of 77 across 5,084 interventional studies indexed under Obesity.
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Exclusion Criteria:
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)
Control: thirty-nine obese individuals were submitted to a low-caloric diet (500 kcal/d of energy restriction) during 12 weeks.
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).
Body-weight
Time frame: 12 weeks
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
No study locations are listed for this record.
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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São Paulo State University