Weight Loss and Abdominal Fat Responses to Different Diet Compositions

Weight Loss and Visceral Fat Responses to Different Diet Compositions

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.

Study Overview

• Status: Unknown
• Conditions: Obesity; Metabolic Syndrome; Insulin Resistance
• Intervention / Treatment: Other: Low Carbohydrate Diet; Other: Low Fat Diet

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Reno, Nevada, United States, 89557
      • Center for Nutrition and Metabolism at the University of Nevada School of Medicine, Reno

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in weight in kg	24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in visceral fat via bioimpedance	24 weeks

Collaborators and Investigators

• Sponsor: University of Nevada, Las Vegas
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (ANTICIPATED): June 1, 2011
• Study Completion (ANTICIPATED): June 1, 2011

Study Registration Dates

• First Submitted: December 16, 2009
• First Submitted That Met QC Criteria: December 16, 2009
• First Posted (ESTIMATE): December 17, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): April 30, 2010
• Last Update Submitted That Met QC Criteria: April 29, 2010
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Keywords: Obesity
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Body Weight; Hyperinsulinism; Body Weight Changes; Metabolic Syndrome; Weight Loss; Insulin Resistance
• Other Study ID Numbers: B08/09-031