Clinical trial NCT01034046: Weight Loss and Abdominal Fat Responses to Different Diet Compositions
Official title: Weight Loss and Visceral Fat Responses to Different Diet Compositions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Insulin Resistance
Metabolic Syndrome
Keywords: Obesity
Lead sponsor: University of Nevada, Las Vegas
Sponsor class: OTHER
Collaborators: name: Jenny Craig, Inc.
First posted: 2009-12-17
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change in weight in kg
timeFrame: 24 weeks
Secondary outcomes:
measure: Change in visceral fat via bioimpedance
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Reno
country: United States
facility: Center for Nutrition and Metabolism at the University of Nevada School of Medicine, Reno
state: Nevada
Study officials:
affiliation: University of Nevada School of Medicine, Reno
name: Raymond A Plodkowski, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Nevada School of Medicine, Reno
name: Sachiko T St. Jeor, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References: