OverweightNCT00932516
Effect of South Beach Diet (SBD™) Using SBD™ Products Compared to a Calorie-Restricted Diet in Women
A study testing South Beach Diet™ with South Beach Diet™ Products, South Beach Diet™ and Calorie restricted diet with South Beach Diet™ Products in people with Overweight, run by Mondelēz International, Inc. at 4 sites in United States.
Trial summary
The purpose of this study is to examine the effectiveness of the South Beach Diet™ and South Beach Diet™ products compared to a traditional calorie restricted diet. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Overweight
- What is being tested?
- South Beach Diet™ with South Beach Diet™ Products, South Beach Diet™ and Calorie restricted diet with South Beach Diet™ Products
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 4 sitesUnited States
- Study dates
- Mar 2007to Apr 2008
- 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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female age 18 to 55 years
- Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result
- Healthy as determined by laboratory results and medical history
- Waist circumference > 87 cm
- Stable weight defined as < 4.5 kg gained or lost in past 3 months
- Agreement to maintain current level of physical activity throughout the study
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- Ability to comprehend and complete the questionnaires and forms
- Agreement to comply with study procedures, test article consumption and has access to a microwave oven
- Voluntary, written, informed consent to participate in the study
Who cannot join
- Pregnant, breastfeeding, or planning to become pregnant during the course of the trial
- Use of prescription or over the counter products known to effect weight including but not limited to the following: megestrol acetate; somatropin; sibutramine; orlistat; paroxetine; dextroamphetamine; methylphenidate; atomoxetine; quetiapine; olanzepine; risperidone, within 4 weeks of randomization and during the trial
- Alcohol use > 2 standard alcoholic drinks per day
- Significant cardiac history defined as a history of myocardial infarction (MI); coronary angioplasty or bypass graft(s); valvular disease or repair; unstable angina pectoris; transient ischemic attack (TIA); cerebrovascular accidents (CVA); congestive heart failure; or coronary artery disease (CAD)
- History of or current diagnosis of any cancer (except for successfully treated basal cell carcinoma) diagnosed less than 5 years prior to screening Subjects with cancer in full remission for more than 5 years are acceptable
- Uncontrolled hypertension defined as untreated systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg
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- Diabetes mellitus Type I or Type II
- Unstable renal and/or liver disease
- History of alcohol or drug abuse within the past year
- Unstable psychiatric disorder requiring hospitalization within the past 6 months
- Immunocompromised individuals such as subjects that have undergone organ transplantation or subjects diagnosed with human immunodeficiency virus (HIV)
- History of hemoglobinopathies such as sickle cell anemia or thalassemia, sideroblastic anemia
- Participation in another clinical research trial within 30 days prior to randomization and during the trial
- Significant abnormal liver function as defined as AST and/or ALT > 2 x ULN, and/or bilirubin > 2 x ULN
- Serum creatinine > 125 umol/L
- Anemia of any etiology defined as hemoglobin < 110 g/L
- Uncontrolled and/or untreated thyroid disorder
- Unstable medications (Dosage must be stable for 90 days prior to randomization)
- History of food allergies or sensitivities including lactose intolerance
- Vegetarians
- Cognitively impaired and/or unable to give informed consent
- Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject
Trial locations and contacts
4 sites in 1 country.
United States4 sites
SIBR Research
Bradenton, Florida, 34205
Miami Research Associates
Miami, Florida, 33143
Medicus Research
Northridge, California, 91325
Chase Wellness & Research Center
Virginia Beach, Virginia, 23455
About this study
Official title: The Effect of South Beach Diet™ Using South Beach Diet™ Products Compared to a Traditional Calorie-Restricted Diet in Non-Diabetic Women
The purpose of this study is to examine the effectiveness of the South Beach Diet™ and South Beach Diet™ products compared to a traditional calorie restricted diet.
- Conditions
- Overweight
- Being tested
- South Beach Diet™ with South Beach Diet™ Products, South Beach Diet™, Calorie restricted diet with South Beach Diet™ Products, Calorie Restricted Diet
- Keywords
- South Beach Diet™, overweight, obesity, satiety, weight loss
- Medical subject headings
- Overweight, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
South Beach Diet™ with South Beach Diet™ ProductsBehavioural
South Beach Diet™Behavioural
Calorie restricted diet with South Beach Diet™ ProductsBehavioural
Calorie Restricted DietBehavioural
| Study group | Role | What they receive |
|---|---|---|
| South Beach Diet™ with SBD™ Products | Active comparator | Not described Receives: Behavioral: South Beach Diet™ with South Beach Diet™ Products |
| South Beach Diet™ alone | Active comparator | Not described Receives: Behavioral: South Beach Diet™ |
| Calorie restricted diet w/ SBD™ Products | Active comparator | Not described Receives: Behavioral: Calorie restricted diet with South Beach Diet™ Products |
| Calorie Restricted Diet alone | Active comparator | Not described Receives: Behavioral: Calorie Restricted Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight from baseline to week 24
Measured: 24 weeks
Secondary outcomes (2)
Assess the satiety response to the individual diets
Measured: 24 weeks
Analyze circumference measurements & body composition; blood glucose, HbA1c, insulin, lipid profile, blood pressure & questionnaire responses on food cravings and quality of life
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2009 (estimated)
- Study startMar 2007
- Primary completionMar 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mondelēz International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Investigators
- David Crowley, MD, Study director, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00932516
- Sponsor's protocol ID
- 07SWHK-NONDIABETIC
- Status last verified
- Jul 2009
- First submitted
- 30 Jun 2009
- Last updated
- 3 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of South Beach Diet™ Using South Beach Diet™ Products Compared to a Traditional Calorie-Restricted Diet in Non-Diabetic Women
- ClinicalTrials.gov ID
- NCT00932516
- Acronym / sponsor ID
- 07SWHK-NONDIABETIC
- Conditions
- Overweight
- Keywords
- South Beach Diet™, overweight, obesity, satiety, weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Mondelēz International, Inc.Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Study start
- Mar 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 3 Jul 2009 (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.
The purpose of this study is to examine the effectiveness of the South Beach Diet™ and South Beach Diet™ products compared to a traditional calorie restricted diet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| South Beach Diet™ with SBD™ Products | Active comparator | Behavioral: South Beach Diet™ with South Beach Diet™ Products |
| South Beach Diet™ alone | Active comparator | Behavioral: South Beach Diet™ |
| Calorie restricted diet w/ SBD™ Products | Active comparator | Behavioral: Calorie restricted diet with South Beach Diet™ Products |
| Calorie Restricted Diet alone | Active comparator | Behavioral: Calorie Restricted Diet |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Female age 18 to 55 years
- Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result
- Healthy as determined by laboratory results and medical history
- Waist circumference > 87 cm
- Stable weight defined as < 4.5 kg gained or lost in past 3 months
Key exclusion criteria (22 listed)
- Pregnant, breastfeeding, or planning to become pregnant during the course of the trial
- Use of prescription or over the counter products known to effect weight including but not limited to the following: megestrol acetate; somatropin; sibutramine; orlistat; paroxetine; dextroamphetamine; methylphenidate; atomoxetine; quetiapine; olanzepine; risperidone, within 4 weeks of randomization and during the trial
- Alcohol use > 2 standard alcoholic drinks per day
- Significant cardiac history defined as a history of myocardial infarction (MI); coronary angioplasty or bypass graft(s); valvular disease or repair; unstable angina pectoris; transient ischemic attack (TIA); cerebrovascular accidents (CVA); congestive heart failure; or coronary artery disease (CAD)
- History of or current diagnosis of any cancer (except for successfully treated basal cell carcinoma) diagnosed less than 5 years prior to screening Subjects with cancer in full remission for more than 5 years are acceptable
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 |
|---|---|---|
| South Beach Diet™ with South Beach Diet™ Products | Behavioural | South Beach Diet™ with SBD™ Products |
| South Beach Diet™ | Behavioural | South Beach Diet™ alone |
| Calorie restricted diet with South Beach Diet™ Products | Behavioural | Calorie restricted diet w/ SBD™ Products |
| Calorie Restricted Diet | Behavioural | Calorie Restricted Diet alone |
Primary outcome
Change in body weight from baseline to week 24
Time frame: 24 weeks
2 secondary outcomes
Assess the satiety response to the individual diets
Time frame: 24 weeks
Analyze circumference measurements & body composition; blood glucose, HbA1c, insulin, lipid profile, blood pressure & questionnaire responses on food cravings and quality of life
Time frame: 24 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 3 Jul 2009.
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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.
David Crowley, MD study director
KGK Science Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing South Beach Diet™ with South Beach Diet™ Products, South Beach Diet™ and Calorie restricted diet with South Beach Diet™ Products in people with Overweight, run by Mondelēz International, Inc. at 4 sites in United States.
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 9 inclusion and 22 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 3 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
Change in body weight from baseline to week 24 (time frame: 24 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 3 Jul 2009.