Weight Loss and Abdominal Fat Responses to Different Diet Compositions
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|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator)|
Change in weight in kg
time frame: 24 weeks
Change in visceral fat via bioimpedance
time frame: 24 weeks
Female participants from 18 years up to 65 years old.
- Females between 18 and 65 years of age.
- BMI 30-40 kg/m2
- Stable weight within 10 lb (+/-) for last 2 months
- 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.
|Official title||Weight Loss and Visceral Fat Responses to Different Diet Compositions|
|Principal investigator||Raymond A Plodkowski, MD|
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