NCT00931034

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Mar 2007

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 2, 2009

Completed
Last Updated

July 2, 2009

Status Verified

June 1, 2009

Enrollment Period

1.1 years

First QC Date

June 29, 2009

Last Update Submit

June 30, 2009

Conditions

Type 2 Diabetes Mellitus

Keywords

South Beach Diet™overweightobesitysatietyweight lossdiabetes

Outcome Measures

Primary Outcomes (1)

  • Change in body weight from baseline to week 24

    24 weeks

Secondary Outcomes (2)

  • Assess the satiety response to the individual diets

    24 weeks

  • Analyze circumference measurements & body composition; blood glucose, HbA1c, insulin, lipid profile, blood pressure & questionnaire responses on food cravings and quality of life

    24 weeks

Study Arms (2)

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

Interventions

South Beach Diet with South Beach Diet ProductsBEHAVIORAL
South Beach Diet with SBD Products
American Diabetes Association Diabetes Meal PlanBEHAVIORAL
ADA Diabetes meal plan

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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:
  • +25 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Medicus Research

Northridge, California, 91325, United States

Location

SIBR Research

Bradenton, Florida, 34205, United States

Location

Miami Research Associates

Miami, Florida, 33143, United States

Location

Nevada Alliance Against Diabetes

Las Vegas, Nevada, 89101, United States

Location

Rochester Clinical Research Inc

Rochester, New York, 14609, United States

Location

Chase Wellness & Research Center

Virginia Beach, Virginia, 23455, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2OverweightObesityWeight LossDiabetes Mellitus

Interventions

Diet, High-Protein Low-Carbohydrate

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-RestrictedDiet TherapyNutrition TherapyTherapeuticsDiet, High-ProteinDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • David Crowley, MD

    KGK Science Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 29, 2009

First Posted

July 2, 2009

Study Start

March 1, 2007

Primary Completion

April 1, 2008

Study Completion

July 1, 2008

Last Updated

July 2, 2009

Record last verified: 2009-06

Locations

US(6)