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

NCT02914249 | Completed

• 1 other identifier: SaoPSU1
• Study Type: interventional
• Target: 78
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity

Keywords

Orange juice; Low-calorie diet; Body composition; Weight-loss; Metabolic biomarkers; Obese

Outcome Measures

Primary Outcomes (1)

• Body-weight

  12 weeks

Secondary Outcomes (20)

• Body mass index (BMI)

  12 weeks

• Body lean mass

  12 weeks

• Body fat mass

  12 weeks

• Percentage of body fat

  12 weeks

• Ratio waist/hip

  12 weeks

Study Arms (2)

Orange juice

EXPERIMENTAL

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

NO INTERVENTION

Control: thirty-nine obese individuals were submitted to a low-caloric diet (500 kcal/d of energy restriction) during 12 weeks.

Interventions

Orange juice (500 mL/d) OTHER

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).

Orange juice

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \> BMI \< 40 kg/m2

You may not qualify if:

• Dieting last year,
• Use of drugs, vitamins and dietary supplements
• Alcohol consumption (\> 20 g alcohol/d)
• Intense physical activity (\> 5 hours/week).

Sponsors & Collaborators

• São Paulo State University: lead
• National Association of Exporters of Citrus Juices: collaborator
• Citrosuco Company: collaborator

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Thais B Cesar, Ph.D.

  Sao Paulo State University "Julio de Mesquita Filho" (UNESP)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 22, 2016
• First Posted: September 26, 2016
• Study Start: September 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 28, 2016

Record last verified: 2016-09