Clinical trial NCT02914249: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Orange juice
Low-calorie diet
Body composition
Weight-loss
Metabolic biomarkers
Obese
Lead sponsor: São Paulo State University
Sponsor class: OTHER
Collaborators: name: National Association of Exporters of Citrus Juices
name: Citrosuco Company
First posted: 2016-09-26
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Body-weight
timeFrame: 12 weeks
Secondary outcomes:
measure: Body mass index (BMI)
timeFrame: 12 weeks
measure: Body lean mass
timeFrame: 12 weeks
measure: Body fat mass
timeFrame: 12 weeks
measure: Percentage of body fat
timeFrame: 12 weeks
measure: Ratio waist/hip
timeFrame: 12 weeks
measure: Glucose
timeFrame: 12 weeks
measure: Insulin
timeFrame: 12 weeks
measure: Homeostatic Model assessment of Insulin Resistance
timeFrame: 12 weeks
measure: Total cholesterol
timeFrame: 12 weeks
measure: LDL-cholesterol
timeFrame: 12 weeks
measure: HDL-cholesterol
timeFrame: 12 weeks
measure: Non-HDL-cholesterol
timeFrame: 12 weeks
measure: Triglycerides
timeFrame: 12 weeks
measure: hsCRP
timeFrame: 12 weeks
measure: Alkaline phosphatase
timeFrame: 12 weeks
measure: Aspartate transaminase
timeFrame: 12 weeks
measure: Alanine transaminase
timeFrame: 12 weeks
measure: Gamma-glutamyl transferase
timeFrame: 12 weeks
measure: Antioxidant capacity (ABTS)
timeFrame: 12 weeks
measure: Lipid peroxidation (TBARS)
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Sao Paulo State University "Julio de Mesquita Filho" (UNESP)
name: Thais B Cesar, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: