ObesityLCD-OJ-OBESENCT02914249
Effect of Low-calorie Diet and Orange Juice on Body Weight and Metabolic Parameters of Obese Subjects
A study testing Orange juice (500 mL/d) in people with Obesity, run by São Paulo State University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Orange juice (500 mL/d)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 30 > BMI < 40 kg/m2
Who cannot join
- Dieting last year,
- Use of drugs, vitamins and dietary supplements
- Alcohol consumption (> 20 g alcohol/d)
- Intense physical activity (> 5 hours/week).
About this study
Official title: Low-calorie Diet Combined With Orange Juice Results in Weight Loss: Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Orange juice (500 mL/d)
- Keywords
- Orange juice, Low-calorie diet, Body composition, Weight-loss, Metabolic biomarkers, Obese
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body-weight
Measured: 12 weeks
Secondary outcomes (20)
Body mass index (BMI)
Measured: 12 weeks
Body lean mass
Measured: 12 weeks
Body fat mass
Measured: 12 weeks
Percentage of body fat
Measured: 12 weeks
Ratio waist/hip
Measured: 12 weeks
Glucose
Measured: 12 weeks
Insulin
Measured: 12 weeks
Homeostatic Model assessment of Insulin Resistance
Measured: 12 weeks
Total cholesterol
Measured: 12 weeks
LDL-cholesterol
Measured: 12 weeks
HDL-cholesterol
Measured: 12 weeks
Non-HDL-cholesterol
Measured: 12 weeks
Triglycerides
Measured: 12 weeks
hsCRP
Measured: 12 weeks
Alkaline phosphatase
Measured: 12 weeks
Aspartate transaminase
Measured: 12 weeks
Alanine transaminase
Measured: 12 weeks
Gamma-glutamyl transferase
Measured: 12 weeks
Antioxidant capacity (ABTS)
Measured: 12 weeks
Lipid peroxidation (TBARS)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study startSep 2015
- Primary completionJan 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- São Paulo State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Association of Exporters of Citrus Juices, Citrosuco Company
- Responsible party
- Principal investigator, Thais Cesar, São Paulo State University
- Investigators
- Thais B Cesar, Ph.D., Principal investigator, Sao Paulo State University "Julio de Mesquita Filho" (UNESP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02914249
- Sponsor's protocol ID
- SaoPSU1
- Acronym
- LCD-OJ-OBESE
- Status last verified
- Sep 2016
- First submitted
- 22 Sep 2016
- Last updated
- 28 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-calorie Diet Combined With Orange Juice Results in Weight Loss: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02914249
- Acronym / sponsor ID
- LCD-OJ-OBESE / SaoPSU1
- Conditions
- Obesity
- Keywords
- Orange juice, Low-calorie diet, Body composition, Weight-loss, Metabolic biomarkers, Obese
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- São Paulo State UniversityUniversity, hospital or other
- Collaborators
- National Association of Exporters of Citrus Juices, Citrosuco Company
- Study start
- Sep 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 26 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orange juice | Experimental | Other: Orange juice (500 mL/d)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. |
| Control | No intervention | –Control: thirty-nine obese individuals were submitted to a low-caloric diet (500 kcal/d of energy restriction) during 12 weeks. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 30 > BMI < 40 kg/m2
Key exclusion criteria (4 listed)
- Dieting last year,
- Use of drugs, vitamins and dietary supplements
- Alcohol consumption (> 20 g alcohol/d)
- Intense physical activity (> 5 hours/week).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Other | Orange juice |
Primary outcome
Body-weight
Time frame: 12 weeks
20 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thais B Cesar, Ph.D. principal investigator
Sao Paulo State University "Julio de Mesquita Filho" (UNESP)
Questions about this trial
What is this clinical trial studying?
A study testing Orange juice (500 mL/d) in people with Obesity, run by São Paulo State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body-weight (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2016.