Weight Loss and Abdominal Fat Responses to Different Diet Compositions

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by University of Nevada, Las Vegas.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Jenny Craig, Inc.
Information provided by:
University of Nevada, Las Vegas
ClinicalTrials.gov Identifier:
NCT01034046
First received: December 16, 2009
Last updated: April 29, 2010
Last verified: December 2009
  Purpose

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.


Condition Intervention
Obesity
Insulin Resistance
Metabolic Syndrome
Other: Low Carbohydrate Diet
Other: Low Fat Diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Weight Loss and Visceral Fat Responses to Different Diet Compositions

Resource links provided by NLM:


Further study details as provided by University of Nevada, Las Vegas:

Primary Outcome Measures:
  • Change in weight in kg [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in visceral fat via bioimpedance [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: April 2009
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01034046

Locations
United States, Nevada
Center for Nutrition and Metabolism at the University of Nevada School of Medicine, Reno
Reno, Nevada, United States, 89557
Sponsors and Collaborators
University of Nevada, Las Vegas
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
  More Information

No publications provided

Responsible Party: Raymond Plodkowski, MD, University of Nevada School of Medicine, Reno
ClinicalTrials.gov Identifier: NCT01034046     History of Changes
Other Study ID Numbers: B08/09-031
Study First Received: December 16, 2009
Last Updated: April 29, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nevada, Las Vegas:
Obesity

Additional relevant MeSH terms:
Insulin Resistance
Obesity
Weight Loss
Metabolic Syndrome X
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on August 26, 2014