Insulin Resistance, Metabolic Syndrome, Obesity
Conditions
Keywords
Obesity
Brief summary
The purpose of this study is to assess the effectiveness of two different reduced calorie diets that have different combinations of carbohydrate, fat, and protein content in 2 groups of study participants: insulin sensitive participants and insulin resistant participants. The hypothesis of the study is that people with high and low levels of insulin resistance may respond differently to different diet compositions in a real-world environment using meals that are commonly available.
Interventions
OTHERLow Carbohydrate Diet
Low carbohydrate diet (45% carbohydrate, 35% fat and 20% protein diet) administered utilizing meal replacements.
OTHERLow Fat Diet
Low fat diet (60% carbohydrate, 20% fat and 20% protein diet) administered utilizing meal replacements.
Sponsors
Jenny Craig, Inc.
University of Nevada, Las Vegas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Females between 18 and 65 years of age. * BMI 30-40 kg/m2 * Stable weight within 10 lb (+/-) for last 2 months
Exclusion criteria
* Pregnant or lactating. * Must not currently be part of a structured weight loss program * Taking a medication for diabetes (such as insulin, metformin, glyburide, glipizide, Byetta, pioglitazone, or rosiglitazone) or a medication such as systemic glucocorticoids that are known to affect blood sugar or blood insulin. * Beck Depression Inventory (BDI Score \>19 and/or positively endorses the suicide question on the BDI-II) * Taking any chronic medication that has not had a stable dose for 1 month or longer. * Diabetes mellitus defined as a fasting glucose ≥ 126 mg/dL on screening. * Taking medications or dietary supplements that cause weight gain or weight loss (eg. antipsychotics (Seroquel, Zyprexa, and Risperdal) and/or anorectics). * Clinically significant laboratory abnormalities at the opinion of the investigators. * History of Bariatric Surgery * A history of: * Type 2 diabetes, type 1 diabetes, or diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g. Cushing's syndrome and acromegaly. * Liver disease, such as cirrhosis, or chronic active hepatitis B or C. * Use of investigational drugs within 30 days of visit 1 * A pacemaker. * Hospitalization for depression in the past 6 months, history of moderate to severe major depression. * Any other condition that in the investigators' or sponsor's opinion could interfere with the results of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in weight in kg | 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change in visceral fat via bioimpedance | 24 weeks |
Countries
United States
Outcome results
None listed