Weight Loss and Abdominal Fat Responses to Different Diet Compositions

Nevada System of Higher Education (NSHE)

Status: Unknown

Conditions: Insulin Resistance; Obesity; Metabolic Syndrome

Treatments: Other: Low Carbohydrate Diet; Other: Low Fat Diet

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01034046

B08/09-031

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Insulin Sensitive Study Participants

Active Comparator group

Description:

Insulin sensitive subjects stratified using fasting insulin levels.

Treatment:

Other: Low Carbohydrate Diet

Other: Low Fat Diet

Insulin Resistant Study Subjects

Active Comparator group

Description:

Insulin resistant subjects stratified using fasting insulin levels.

Treatment:

Other: Low Carbohydrate Diet

Other: Low Fat Diet