ObesityNCT00575900
Low Carbohydrates in Obese Adolescents
A study testing dietary intervention in people with Obesity, run by Rabin Medical Center at 1 site in Israel.
Trial summary
A three arms open,randomized interventional study in order to compare the impact of low carbohydrate diets with different protein and fat ratios versus a standard balanced diet on BMI and metabolic parameters in obese adolescents. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- dietary intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2005to Feb 2006
- 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 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- aged 12 to 18
- body mass index (BMI) values greater than the 95th percentile for age and gender according to the growth charts of the Center for Disease Control and Prevention.
Who cannot join
- 1.Patients with a chronic disease (such as diabetes, renal, heart or liver diseases, thyroid function disorder, or diagnosed psychological disorder). 2.Patients receiving weight-loss-inducing medication.
- 3.Subjects who had participated in another weight loss-study or slimming diet within two months prior to the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Low Carbohydrate Low Fat, Low Carbohydrate High Fat and Balanced Low Fat Diets in the Treatment of Obesity in Adolescents- a Randomized Controlled Trail.
A three arms open,randomized interventional study in order to compare the impact of low carbohydrate diets with different protein and fat ratios versus a standard balanced diet on BMI and metabolic parameters in obese adolescents.
55 obese adolescents (12-18y, BMI > 95th percentile) were randomly allocated to one of three 12-weeks diet regimens: low-carbohydrate low-fat, low-carbohydrate high-fat or balanced low-fat diet, followed by 9-months follow-up. Weight, Height, waist circumference, lipid profile, glucose, insulin, liver enzymes, renal functions, C-reactive protein, leptin, ghrelin and resting energy expenditure were measured in the morning after over-night fast at baseline, during the 12-weeks of intervention and after 9-months of follow-up.
Read the detailed description
A three arms open,randomized interventional study in order to compare the impact of low carbohydrate diets with different protein and fat ratios versus a standard balanced diet on BMI and metabolic parameters in obese adolescents.
Study design:
The study included 12 weeks of intervention followed by 9 months of follow up, between March 2005 to February 2006. Participants were randomly allocated to one of three diet groups.
Group 1: Low carbohydrate, low fat, protein rich diet containing 1200 kcal a day, 60-gr carbohydrates (20%), 40-gr fat (30%), 150-gr protein (50%).
Group 2: Low carbohydrate fat rich diet containing 1200 kcal a day, 60-gr carbohydrates (20%), 80-gr fat (60%), 60-gr protein (20%).
Group 3: A balanced low fat diet containing 1200 kcal a day, 150 - 180-gr carbohydrates (50 - 60%), 40-gr fat (30%), 60-gr protein (20%).
All participant received menus and detailed instruction according to their group.
During the intervention participant attended weekly sessions with a dietitian and a psychologist and a tests and measures scheduled for each time point were performed (see Measures section). In some sessions the participants were requested to fill-out self reports food dairies. All received general recommendations to exercise physical activity.
At the end of the intervention period (12th week), all participants were given instruction for a balanced maintenance diet for the following year.
measures: Anthropometric assessment (weight,height, waist circumference) included baseline and weekly measurement during the 12- week intervention, and thereafter every three months for 9-months of follow-up. Body composition was evaluated at baseline and after the 12- week intervention, after overnight fasting by bioimpedance analysis (BIA). Resting energy expenditure (REE) was assessed at baseline and after the 12- week intervention, in the morning after overnight fasting by means of indirect calorimetry. Urine was collected every week during the intervention period for assay of ketone and protein level. Fasting blood tests were preformed at baseline, weeks 7 and 12, and at the end of the follow-up to measure the following parameters: total cholesterol, Low Density Lipoprotein (LDL), HDL cholesterol, triglycerides, glucose, insulin, blood urea nitrogen, creatinine, total protein, liver enzymes (AST, ALT, GGT ),renal functions (urea, creatinine, electrolytes, uric acid), electrolyte level, Insulin like growth factor (IGF1), haemoglobin, C-reactive protein (CRP), TSH, free T4, iron, vitamin B12, folic acid ,leptin ,and ghrelin.
- Conditions
- Obesity
- Being tested
- dietary intervention
- Keywords
- Adolescent obesity,, low carbohydrate diets, metabolic risk factors, BMI
- Medical subject headings
- Obesity, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary interventionBehavioural
12 weeks of dietary intervention
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Low carbohydrate and low fat. Receives: Behavioral: dietary intervention |
| 2 | Experimental | Low carbohydrate fat rich diet Receives: Behavioral: dietary intervention |
| 3 | Active comparator | A balanced low fat diet Receives: Behavioral: dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI, BMI-SDS, Body fat percentage, waist circumference
Measured: At baseline visit, end of 12 weeks of intervention and every three months after during the 9 months follow-up
Secondary outcomes (1)
Blood metabolic profile, CRP, Ghrelin and Leptin levels, Resting energy expenditure, Psychological parameters
Measured: At baseline, after 12 weeks of intervention and after 9 weeks of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2007 (estimated)
- Study startMar 2005
- Study completionFeb 2006
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
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Moshe Phillip, Professor, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00575900
- Sponsor's protocol ID
- rmc003187ctil
- Other IDs
- Low carbohydrate diets
- Status last verified
- Dec 2007
- First submitted
- 16 Dec 2007
- Last updated
- 18 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Low Carbohydrate Low Fat, Low Carbohydrate High Fat and Balanced Low Fat Diets in the Treatment of Obesity in Adolescents- a Randomized Controlled Trail.
- ClinicalTrials.gov ID
- NCT00575900
- Acronym / sponsor ID
- rmc003187ctil
- Conditions
- Obesity
- Keywords
- Adolescent obesity,, low carbohydrate diets, metabolic risk factors, BMI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Mar 2005
- Study completion
- Feb 2006 (actual)
- First posted
- 18 Dec 2007 (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.
A three arms open,randomized interventional study in order to compare the impact of low carbohydrate diets with different protein and fat ratios versus a standard balanced diet on BMI and metabolic parameters in obese adolescents.
55 obese adolescents (12-18y, BMI > 95th percentile) were randomly allocated to one of three 12-weeks diet regimens: low-carbohydrate low-fat, low-carbohydrate high-fat or balanced low-fat diet, followed by 9-months follow-up. Weight, Height, waist circumference, lipid profile, glucose, insulin, liver enzymes, renal functions, C-reactive protein, leptin, ghrelin and resting energy expenditure were measured in the morning after over-night fast at baseline, during the 12-weeks of intervention and after 9-months of follow-up.
Detailed description
A three arms open,randomized interventional study in order to compare the impact of low carbohydrate diets with different protein and fat ratios versus a standard balanced diet on BMI and metabolic parameters in obese adolescents.
Study design:
The study included 12 weeks of intervention followed by 9 months of follow up, between March 2005 to February 2006. Participants were randomly allocated to one of three diet groups.
Group 1: Low carbohydrate, low fat, protein rich diet containing 1200 kcal a day, 60-gr carbohydrates (20%), 40-gr fat (30%), 150-gr protein (50%).
Group 2: Low carbohydrate fat rich diet containing 1200 kcal a day, 60-gr carbohydrates (20%), 80-gr fat (60%), 60-gr protein (20%).
Group 3: A balanced low fat diet containing 1200 kcal a day, 150 - 180-gr carbohydrates (50 - 60%), 40-gr fat (30%), 60-gr protein (20%).
All participant received menus and detailed instruction according to their group.
During the intervention participant attended weekly sessions with a dietitian and a psychologist and a tests and measures scheduled for each time point were performed (see Measures section). In some sessions the participants were requested to fill-out self reports food dairies. All received general recommendations to exercise physical activity.
At the end of the intervention period (12th week), all participants were given instruction for a balanced maintenance diet for the following year.
measures: Anthropometric assessment (weight,height, waist circumference) included baseline and weekly measurement during the 12- week intervention, and thereafter every three months for 9-months of follow-up. Body composition was evaluated at baseline and after the 12- week intervention, after overnight fasting by bioimpedance analysis (BIA). Resting energy expenditure (REE) was assessed at baseline and after the 12- week intervention, in the morning after overnight fasting by means of indirect calorimetry. Urine was collected every week during the intervention period for assay of ketone and protein level. Fasting blood tests were preformed at baseline, weeks 7 and 12, and at the end of the follow-up to measure the following parameters: total cholesterol, Low Density Lipoprotein (LDL), HDL cholesterol, triglycerides, glucose, insulin, blood urea nitrogen, creatinine, total protein, liver enzymes (AST, ALT, GGT ),renal functions (urea, creatinine, electrolytes, uric acid), electrolyte level, Insulin like growth factor (IGF1), haemoglobin, C-reactive protein (CRP), TSH, free T4, iron, vitamin B12, folic acid ,leptin ,and ghrelin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: dietary interventionLow carbohydrate and low fat. |
| 2 | Experimental | Behavioral: dietary interventionLow carbohydrate fat rich diet |
| 3 | Active comparator | Behavioral: dietary interventionA balanced low fat diet |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- aged 12 to 18
- body mass index (BMI) values greater than the 95th percentile for age and gender according to the growth charts of the Center for Disease Control and Prevention.
Key exclusion criteria (2 listed)
- 1.Patients with a chronic disease (such as diabetes, renal, heart or liver diseases, thyroid function disorder, or diagnosed psychological disorder). 2.Patients receiving weight-loss-inducing medication.
- 3.Subjects who had participated in another weight loss-study or slimming diet within two months prior to the study.
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 |
|---|---|---|
| dietary intervention12 weeks of dietary intervention | Behavioural | 1, 2, 3 |
Primary outcome
BMI, BMI-SDS, Body fat percentage, waist circumference
Time frame: At baseline visit, end of 12 weeks of intervention and every three months after during the 9 months follow-up
1 secondary outcome
Blood metabolic profile, CRP, Ghrelin and Leptin levels, Resting energy expenditure, Psychological parameters
Time frame: At baseline, after 12 weeks of intervention and after 9 weeks of follow-up
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 18 Dec 2007.
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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.
Moshe Phillip, Professor principal investigator
Rabin Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dietary intervention in people with Obesity, run by Rabin Medical Center at 1 site in Israel.
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 2 inclusion and 2 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 18 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
BMI, BMI-SDS, Body fat percentage, waist circumference (time frame: At baseline visit, end of 12 weeks of intervention and every three months after during the 9 months follow-up). 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 18 Dec 2007.