Overview

This trial is active, not recruiting.

Conditions obesity, insulin resistance, metabolic syndrome
Treatments low carbohydrate diet, low fat diet
Sponsor University of Nevada, Las Vegas
Collaborator Jenny Craig, Inc.
Start date April 2009
End date June 2011
Trial size 100 participants
Trial identifier NCT01034046, B08/09-031

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Active Comparator)
Insulin sensitive subjects stratified using fasting insulin levels.
low carbohydrate diet
Low carbohydrate diet (45% carbohydrate, 35% fat and 20% protein diet) administered utilizing meal replacements.
low fat diet
Low fat diet (60% carbohydrate, 20% fat and 20% protein diet) administered utilizing meal replacements.
(Active Comparator)
Insulin resistant subjects stratified using fasting insulin levels.
low carbohydrate diet
Low carbohydrate diet (45% carbohydrate, 35% fat and 20% protein diet) administered utilizing meal replacements.
low fat diet
Low fat diet (60% carbohydrate, 20% fat and 20% protein diet) administered utilizing meal replacements.

Primary Outcomes

Measure
Change in weight in kg
time frame: 24 weeks

Secondary Outcomes

Measure
Change in visceral fat via bioimpedance
time frame: 24 weeks

Eligibility Criteria

Female participants from 18 years up to 65 years old.

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.

Additional Information

Official title Weight Loss and Visceral Fat Responses to Different Diet Compositions
Principal investigator Raymond A Plodkowski, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2010.
Information provided to ClinicalTrials.gov by University of Nevada, Las Vegas.