Weight Loss and Abdominal Fat Responses to Different Diet Compositions

Study Overview
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Brief Summary
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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.

Official Title
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Weight Loss and Visceral Fat Responses to Different Diet Compositions

Conditions
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Obesity, Insulin Resistance, Metabolic Syndrome

Intervention / Treatment
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* Other: Low Carbohydrate Diet
* Other: Low Fat Diet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Insulin Sensitive Study Participants<br>Insulin sensitive subjects stratified using fasting insulin levels. | Other: Low Carbohydrate Diet<br>* Low carbohydrate diet (45% carbohydrate, 35% fat and 20% protein diet) administered utilizing meal replacements.<br>Other: Low Fat Diet<br>* Low fat diet (60% carbohydrate, 20% fat and 20% protein diet) administered utilizing meal replacements.<br>|
| Active Comparator: Insulin Resistant Study Subjects<br>Insulin resistant subjects stratified using fasting insulin levels. | Other: Low Carbohydrate Diet<br>* Low carbohydrate diet (45% carbohydrate, 35% fat and 20% protein diet) administered utilizing meal replacements.<br>Other: Low Fat Diet<br>* Low fat diet (60% carbohydrate, 20% fat and 20% protein diet) administered utilizing meal replacements.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight in kg |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in visceral fat via bioimpedance |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity