Weight Loss and Abdominal Fat Responses to Different Diet Compositions

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

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.

Intervention(s) in this Clinical Trial

• Other: Low Carbohydrate Diet
  • Low carbohydrate diet (45% carbohydrate, 35% fat and 20% protein diet) administered utilizing meal replacements.
• Other: Low Fat Diet
  • Low fat diet (60% carbohydrate, 20% fat and 20% protein diet) administered utilizing meal replacements.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Insulin Sensitive Study Participants
  • Insulin sensitive subjects stratified using fasting insulin levels.
• Active Comparator: Insulin Resistant Study Subjects
  • Insulin resistant subjects stratified using fasting insulin levels.

Primary Measures

• Change in weight in kg
  • Time Frame: 24 weeks
    Safety Issue?: No

Secondary Measures

• Change in visceral fat via bioimpedance
  • Time Frame: 24 weeks
    Safety Issue?: 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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: University of Nevada Other

Overall Clinical Trial Officials and Contacts

Raymond A Plodkowski, MD Principal Investigator University of Nevada School of Medicine, Reno  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01034046

Study ID Number: B08/09-031

ClinicalTrials.gov Identifier: NCT01034046

Health Authority: United States: Institutional Review Board