Weight Loss and Abdominal Fat Responses to Different Diet Compositions

Obesity Clinical Trial

Official title:

Weight Loss and Visceral Fat Responses to Different Diet Compositions

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01034046
• Other study ID #: B08/09-031
• Status: Active, not recruiting
• Phase: N/A
• First received: December 16, 2009
• Last updated: April 29, 2010
• Start date: April 2009
• Est. completion date: June 2011

Study information

• Verified date: December 2009
• Source: University of Nevada, Las Vegas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insulin Resistance
• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Center for Nutrition and Metabolism at the University of Nevada School of Medicine, Reno	Reno	Nevada

Sponsors (2)

Lead Sponsor	Collaborator
University of Nevada, Las Vegas	Jenny Craig, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in weight in kg		24 weeks	No
Secondary	Change in visceral fat via bioimpedance		24 weeks	No