Weight Loss and Abdominal Fat Responses to Different Diet Compositions
NCT ID: NCT01034046
Last Updated: 2010-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2009-04-30
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Insulin Sensitive Study Participants
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.
Insulin Resistant Study Subjects
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* BMI 30-40 kg/m2
* Stable weight within 10 lb (+/-) for last 2 months
Exclusion Criteria
* 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.
18 Years
65 Years
FEMALE
No
Sponsors
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Jenny Craig, Inc.
INDUSTRY
University of Nevada, Las Vegas
OTHER
Responsible Party
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University of Nevada School of Medicine, Reno
Principal Investigators
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Raymond A Plodkowski, MD
Role: PRINCIPAL_INVESTIGATOR
University of Nevada School of Medicine, Reno
Sachiko T St. Jeor, PhD, RD
Role: PRINCIPAL_INVESTIGATOR
University of Nevada School of Medicine, Reno
Locations
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Center for Nutrition and Metabolism at the University of Nevada School of Medicine, Reno
Reno, Nevada, United States
Countries
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Other Identifiers
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B08/09-031
Identifier Type: -
Identifier Source: org_study_id