Type 2 Diabetes MellitusNCT00931034
Effect of South Beach Diet (SBD™) Using SBD™ Products Compared to the American Diabetic Association (ADA) Diabetes Meal Plan on Body Weight and Satiety in Diabetic Women
A study testing South Beach Diet with South Beach Diet Products and American Diabetes Association Diabetes Meal Plan in people with Type 2 Diabetes Mellitus, run by Mondelēz International, Inc. at 6 sites in United States.
Trial summary
The purpose of this study is to examine the effectiveness of the South Beach Diet and products compared to the American Diabetic Association Diabetes Meal Plan. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- South Beach Diet with South Beach Diet Products and American Diabetes Association Diabetes Meal Plan
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 6 sitesUnited States
- Study dates
- Mar 2007to Jul 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 year
- Agreement to maintain current level of physical activity throughout the study
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- Diagnosed with Type II diabetes mellitus with fasting blood glucose 100 - 250 mg/dl (5.6 - 13.9 mmol/L)
- 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;
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- paroxetine;
- dextroamphetamine;
- methylphenidate;
- atomoxetine;
- quetiapine;
- olanzepine;
- risperidone, within 4 weeks of randomization and during the trial
- Unstable medication for diabetes mellitus (Dosage must be stable for 90 days prior to randomization), use of insulin is exclusionary
- 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
- 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
6 sites in 1 country.
6 sites in 1 country
United States6 sites
SIBR Research
Bradenton, Florida, 34205
Nevada Alliance Against Diabetes
Las Vegas, Nevada, 89101
Miami Research Associates
Miami, Florida, 33143
Medicus Research
Northridge, California, 91325
Rochester Clinical Research Inc
Rochester, New York, 14609
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 the American Diabetic Association Diabetes Meal Plan on Body Weight and Satiety in Overweight Diabetic Women
The purpose of this study is to examine the effectiveness of the South Beach Diet and products compared to the American Diabetic Association Diabetes Meal Plan.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- South Beach Diet with South Beach Diet Products, American Diabetes Association Diabetes Meal Plan
- Keywords
- South Beach Diet™, overweight, obesity, satiety, weight loss, diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Overweight, Obesity, Weight Loss, Diabetes Mellitus
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
American Diabetes Association Diabetes Meal PlanBehavioural
| 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 |
| ADA Diabetes meal plan | Active comparator | Not described Receives: Behavioral: American Diabetes Association Diabetes Meal Plan |
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 posted2 Jul 2009 (estimated)
- Study startMar 2007
- Primary completionApr 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- 120 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
- NCT00931034
- Sponsor's protocol ID
- 07SWHK
- Status last verified
- Jun 2009
- First submitted
- 29 Jun 2009
- Last updated
- 2 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 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 the American Diabetic Association Diabetes Meal Plan on Body Weight and Satiety in Overweight Diabetic Women
- ClinicalTrials.gov ID
- NCT00931034
- Acronym / sponsor ID
- 07SWHK
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- South Beach Diet™, overweight, obesity, satiety, weight loss, diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Mondelēz International, Inc.Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Study start
- Mar 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 2 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 products compared to the American Diabetic Association Diabetes Meal Plan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| South Beach Diet with SBD Products | Active comparator | Behavioral: South Beach Diet with South Beach Diet Products |
| ADA Diabetes meal plan | Active comparator | Behavioral: American Diabetes Association Diabetes Meal Plan |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 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 year
Key exclusion criteria (41 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:
- Unstable medication for diabetes mellitus (Dosage must be stable for 90 days prior to randomization), use of insulin is exclusionary
- Alcohol use > 2 standard alcoholic drinks per day
- Significant cardiac history defined as a history of:
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 |
| American Diabetes Association Diabetes Meal Plan | Behavioural | ADA Diabetes meal plan |
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 2 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.
6 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 and American Diabetes Association Diabetes Meal Plan in people with Type 2 Diabetes Mellitus, run by Mondelēz International, Inc. at 6 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 10 inclusion and 41 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 2 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 6 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 2 Jul 2009.