ObesityNCT03558685
Weight Loss Diet in Obesity With Metabolic Syndrome
A study testing Weight loss diet in people with Obesity and Diet Modification, run by Tel-Aviv Sourasky Medical Center.
Trial summary
Concomitant interventions included lifestyle modification with a personally tailored program of diet as detailed below and physical activity adjusted for age and specific physical limitations, targeting engagement in physical activity of at least 150 minutes/week. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity, Diet Modification
- What is being tested?
- Weight loss diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jul 2008to Jul 2018
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- fulfilled the diagnostic criteria for the metabolic syndrome as defined by the Third Report of the Adult Treatment Panel (ATPIII).
Who cannot join
- diabetes
- the presence of current or recent pregnancy or intention to conceive within the trial's period
- chronic renal or liver disease
- past bariatric surgery
- current participation in any dietary/ medical program with current continuous weight loss.
About this study
Official title: Weight Loss Diet in the Treatment of Obese Patients With the Metabolic Syndrome
Concomitant interventions included lifestyle modification with a personally tailored program of diet as detailed below and physical activity adjusted for age and specific physical limitations, targeting engagement in physical activity of at least 150 minutes/week. Lipid lowering and or blood pressure lowering drugs were prescribed as needed according to guideline-assisted medical practice. Patients were seen by a physician every 3 month. The dietitian had a weekly meeting with the patients for the first three months, every other week during months 4-6, once a month during month 7-9 and every 6 weeks during the last three months of the study.
- Conditions
- Obesity, Diet Modification
- Being tested
- Weight loss diet
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight loss dietBehavioural
Nutritional recommendation consisted of moderate caloric restriction, set at 25% to 30% less than calories needed for resting metabolic rate. We applied a high protein Mediterranean diet with the following food group distribution: 30% as protein (> 0.8 g/kg/d); 40% as carbohydrates with medium/low glycemic index; 30% as fat (≥10% monounsaturated fatty acid, ≤7% saturated fatty acid, no trans fats, and 1.6 g omega-3 for men and 1.1 g omega-3 for women). Diet was rich in olive oil, fish, chicken, nuts, white milk products, fruits, and vegetables but low in artificial sugars, commercial sweets, pastries, butter, margarine, and red meat. Dietary fiber content ≥25 g/day
| Study group | Role | What they receive |
|---|---|---|
| Diet | Experimental | Nutritional recommendation consisted of moderate caloric restriction, set at 25% to 30% less than calories needed for resting metabolic rate. We applied a high protein Mediterranean diet with the following food group distribution: 30% as protein (> 0.8 g/kg/d); 40% as carbohydrates with medium/low glycemic index; 30% as fat (≥10%monounsaturated fatty acid, ≤7% saturated fatty acid, no trans fats, and 1.6 g omega-3 for men and 1.1 g omega-3 for women). Diet was rich in olive oil, fish, chicken, nuts, white milk products, fruits, and vegetables but low in artificial sugars, commercial sweets, pastries, butter, margarine, and red meat. Dietary fiber content ≥25 g/day Receives: Behavioral: Weight loss diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
% BMI Change
BMI is calculated as weight in Kg divided by height in meters X height in meters. Percent change will be calculated as the difference in BMI units (kg/m2) between the final BMI and the initial BMI, divided by the initial BMI, multiplied by 100%.
Measured: One Year, from the initiation of the intervention to its termination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study startJul 2008
- Primary completionMay 2017
- Study completionJul 2018 (estimated)
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.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Naftali Stern, MD, Principal investigator, Institute of Endocrinology, Metabolism and Hypertension Tel Aviv-Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03558685
- Sponsor's protocol ID
- 0564-08
- Status last verified
- Jun 2018
- First submitted
- 31 May 2018
- Last updated
- 15 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Loss Diet in the Treatment of Obese Patients With the Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT03558685
- Acronym / sponsor ID
- 0564-08
- Conditions
- Obesity, Diet Modification
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jul 2008 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Jul 2018 (estimated)
- First posted
- 15 Jun 2018 (actual)
- 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.
Concomitant interventions included lifestyle modification with a personally tailored program of diet as detailed below and physical activity adjusted for age and specific physical limitations, targeting engagement in physical activity of at least 150 minutes/week. Lipid lowering and or blood pressure lowering drugs were prescribed as needed according to guideline-assisted medical practice. Patients were seen by a physician every 3 month. The dietitian had a weekly meeting with the patients for the first three months, every other week during months 4-6, once a month during month 7-9 and every 6 weeks during the last three months of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diet | Experimental | Behavioral: Weight loss dietNutritional recommendation consisted of moderate caloric restriction, set at 25% to 30% less than calories needed for resting metabolic rate. We applied a high protein Mediterranean diet with the following food group distribution: 30% as protein (> 0.8 g/kg/d); 40% as carbohydrates with medium/low glycemic index; 30% as fat (≥10%monounsaturated fatty acid, ≤7% saturated fatty acid, no trans fats, and 1.6 g omega-3 for men and 1.1 g omega-3 for women). Diet was rich in olive oil, fish, chicken, nuts, white milk products, fruits, and vegetables but low in artificial sugars, commercial sweets, pastries, butter, margarine, and red meat. Dietary fiber content ≥25 g/day |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- fulfilled the diagnostic criteria for the metabolic syndrome as defined by the Third Report of the Adult Treatment Panel (ATPIII).
Key exclusion criteria (5 listed)
- diabetes
- the presence of current or recent pregnancy or intention to conceive within the trial's period
- chronic renal or liver disease
- past bariatric surgery
- current participation in any dietary/ medical program with current continuous weight loss.
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 |
|---|---|---|
| Weight loss dietNutritional recommendation consisted of moderate caloric restriction, set at 25% to 30% less than calories needed for resting metabolic rate. We applied a high protein Mediterranean diet with the following food group distribution: 30% as protein (> 0.8 g/kg/d); 40% as carbohydrates with medium/low glycemic index; 30% as fat (≥10% monounsaturated fatty acid, ≤7% saturated fatty acid, no trans fats, and 1.6 g omega-3 for men and 1.1 g omega-3 for women). Diet was rich in olive oil, fish, chicken, nuts, white milk products, fruits, and vegetables but low in artificial sugars, commercial sweets, pastries, butter, margarine, and red meat. Dietary fiber content ≥25 g/day | Behavioural | Diet |
Primary outcome
% BMI Change
Time frame: One Year, from the initiation of the intervention to its termination.
BMI is calculated as weight in Kg divided by height in meters X height in meters. Percent change will be calculated as the difference in BMI units (kg/m2) between the final BMI and the initial BMI, divided by the initial BMI, multiplied by 100%.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2018.
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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.
Naftali Stern, MD principal investigator
Institute of Endocrinology, Metabolism and Hypertension Tel Aviv-Sourasky Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Weight loss diet in people with Obesity and Diet Modification, run by Tel-Aviv Sourasky Medical Center.
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 5 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: status not confirmed, as of the sponsor's last update on 15 Jun 2018. 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?
Results are not available in the source record.
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 Change (time frame: One Year, from the initiation of the intervention to its termination.). 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 15 Jun 2018.