Weight Loss and Abdominal Fat Responses to Different Diet Compositions

Not Applicable

• Conditions: Obesity; Insulin Resistance; Metabolic Syndrome
• Interventions: Other: Low Carbohydrate Diet; Other: Low Fat Diet

• Registration Number: NCT01034046
• Lead Sponsor: University of Nevada, Las Vegas

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Status Verified: 2009-12
• Study First Submitted: 2009-12-16
• Study First Submitted QC: 2009-12-16
• Study First Posted: 2009-12-17
• Last Update Submitted: 2010-04-29
• Last Update Posted: 2010-04-30
• Primary Completion: 2011-06
• Study Completion: 2011-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Insulin Sensitive Study Participants	Low Carbohydrate Diet	Insulin sensitive subjects stratified using fasting insulin levels.
Insulin Sensitive Study Participants	Low Fat Diet	Insulin sensitive subjects stratified using fasting insulin levels.
Insulin Resistant Study Subjects	Low Carbohydrate Diet	Insulin resistant subjects stratified using fasting insulin levels.
Insulin Resistant Study Subjects	Low Fat Diet	Insulin resistant subjects stratified using fasting insulin levels.

Primary Outcome Measures

Name	Time	Method
Change in weight in kg	24 weeks

Secondary Outcome Measures

Name	Time	Method
Change in visceral fat via bioimpedance	24 weeks

Trial Locations

Locations (1)

Center for Nutrition and Metabolism at the University of Nevada School of Medicine, Reno; 🇺🇸 Reno, Nevada, United States