Weight Loss and Abdominal Fat Responses to Different Diet Compositions
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by University of Nevada, Las Vegas.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
University of Nevada, Las Vegas
Collaborator:
Jenny Craig, Inc.
Information provided by:
University of Nevada, Las Vegas
ClinicalTrials.gov Identifier:
NCT01034046
First received: December 16, 2009
Last updated: April 29, 2010
Last verified: December 2009
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Obesity Insulin Resistance Metabolic Syndrome |
Other: Low Carbohydrate Diet Other: Low Fat Diet |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Weight Loss and Visceral Fat Responses to Different Diet Compositions |
Resource links provided by NLM:
Further study details as provided by University of Nevada, Las Vegas:
Primary Outcome Measures:
- Change in weight in kg [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in visceral fat via bioimpedance [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Insulin Sensitive Study Participants
Insulin sensitive subjects stratified using fasting insulin levels.
|
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.
|
|
Active Comparator: Insulin Resistant Study Subjects
Insulin resistant subjects stratified using fasting insulin levels.
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01034046
Locations
| United States, Nevada | |
| Center for Nutrition and Metabolism at the University of Nevada School of Medicine, Reno | |
| Reno, Nevada, United States, 89557 | |
Sponsors and Collaborators
University of Nevada, Las Vegas
Jenny Craig, Inc.
Investigators
| Principal Investigator: | Raymond A Plodkowski, MD | University of Nevada School of Medicine, Reno |
| Principal Investigator: | Sachiko T St. Jeor, PhD, RD | University of Nevada School of Medicine, Reno |
More Information
No publications provided
| Responsible Party: | Raymond Plodkowski, MD, University of Nevada School of Medicine, Reno |
| ClinicalTrials.gov Identifier: | NCT01034046 History of Changes |
| Other Study ID Numbers: | B08/09-031 |
| Study First Received: | December 16, 2009 |
| Last Updated: | April 29, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Nevada, Las Vegas:
|
Obesity |
Additional relevant MeSH terms:
|
Insulin Resistance Obesity Weight Loss Metabolic Syndrome X Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |
Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Body Weight Changes |
ClinicalTrials.gov processed this record on May 21, 2013