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Weight Loss and Abdominal Fat Responses to Different Diet Compositions

Primary Purpose

Obesity, Insulin Resistance, Metabolic Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low Carbohydrate Diet
Low Fat Diet
Sponsored by
University of Nevada, Las Vegas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • Center for Nutrition and Metabolism at the University of Nevada School of Medicine, Reno

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Insulin Sensitive Study Participants

Insulin Resistant Study Subjects

Arm Description

Insulin sensitive subjects stratified using fasting insulin levels.

Insulin resistant subjects stratified using fasting insulin levels.

Outcomes

Primary Outcome Measures

Change in weight in kg

Secondary Outcome Measures

Change in visceral fat via bioimpedance

Full Information

First Posted
December 16, 2009
Last Updated
April 29, 2010
Sponsor
University of Nevada, Las Vegas
Collaborators
Jenny Craig, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01034046
Brief Title
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

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Unknown status
Study Start Date
April 2009 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
June 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Nevada, Las Vegas
Collaborators
Jenny Craig, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Insulin Resistance, Metabolic Syndrome
Keywords
Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Insulin Sensitive Study Participants
Arm Type
Active Comparator
Arm Description
Insulin sensitive subjects stratified using fasting insulin levels.
Arm Title
Insulin Resistant Study Subjects
Arm Type
Active Comparator
Arm Description
Insulin resistant subjects stratified using fasting insulin levels.
Intervention Type
Other
Intervention Name(s)
Low Carbohydrate Diet
Intervention Description
Low carbohydrate diet (45% carbohydrate, 35% fat and 20% protein diet) administered utilizing meal replacements.
Intervention Type
Other
Intervention Name(s)
Low Fat Diet
Intervention Description
Low fat diet (60% carbohydrate, 20% fat and 20% protein diet) administered utilizing meal replacements.
Primary Outcome Measure Information:
Title
Change in weight in kg
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Change in visceral fat via bioimpedance
Time Frame
24 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond A Plodkowski, MD
Organizational Affiliation
University of Nevada School of Medicine, Reno
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sachiko T St. Jeor, PhD, RD
Organizational Affiliation
University of Nevada School of Medicine, Reno
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Nutrition and Metabolism at the University of Nevada School of Medicine, Reno
City
Reno
State/Province
Nevada
ZIP/Postal Code
89557
Country
United States

12. IPD Sharing Statement

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Weight Loss and Abdominal Fat Responses to Different Diet Compositions

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