Weight Loss and Abdominal Fat Responses to Different Diet Compositions

• ClinicalTrials.gov Identifier: NCT01034046
• Recruitment Status: Unknown
• First Posted: December 17, 2009
• Last Update Posted: April 30, 2010
• Sponsor: University of Nevada, Las Vegas
• Collaborator: Jenny Craig, Inc.
• Information provided by: University of Nevada, Las Vegas

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Obesity; Insulin Resistance; Metabolic Syndrome	Other: Low Carbohydrate Diet; Other: Low Fat Diet	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Weight Loss and Visceral Fat Responses to Different Diet Compositions
• Study Start Date: April 2009
• Estimated Primary Completion Date: June 2011
• Estimated Study Completion Date: June 2011

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. Change in weight in kg [ Time Frame: 24 weeks ]

Secondary Outcome Measures :

1. Change in visceral fat via bioimpedance [ Time Frame: 24 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes 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

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

• Responsible Party: Raymond Plodkowski, MD, University of Nevada School of Medicine, Reno
• ClinicalTrials.gov Identifier: NCT01034046
• Other Study ID Numbers: B08/09-031
• First Posted: December 17, 2009
• Last Update Posted: April 30, 2010
• Last Verified: December 2009

Keywords provided by University of Nevada, Las Vegas:

Obesity

Additional relevant MeSH terms:

Metabolic Syndrome; Insulin Resistance; Weight Loss; Body Weight; Body Weight Changes; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases