Weight Loss and Abdominal Fat Responses to Different Diet... | NCT01034046

Studies
Weight Loss and Abdominal Fat Responses to Different Diet Compositions

NCT01034046

Sponsor

University of Nevada, Las Vegas

Status

Unknown status

Last Update Posted

Apr 30, 2010Estimated

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Obesity
Insulin Resistance
Metabolic Syndrome

Interventions

Low Carbohydrate Diet
Low Fat Diet

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Jun 2011Estimated

Completion Date

Jun 2011Estimated

First Submitted Date

Dec 16, 2009

First Submission Date that Met QC Criteria

Dec 16, 2009

First Posted Date

Dec 17, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 29, 2010

Last Update Posted Date

Apr 30, 2010Estimated

Name	Class
Jenny Craig, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Insulin Sensitive Study Participants	Active Comparator	Insulin sensitive subjects stratified using fasting insulin levels.	Other: Low Carbohydrate Diet Other: Low Fat Diet
Insulin Resistant Study Subjects	Active Comparator	Insulin resistant subjects stratified using fasting insulin levels.	Other: Low Carbohydrate Diet Other: Low Fat Diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Low Carbohydrate Diet	Other	Low carbohydrate diet (45% carbohydrate, 35% fat and 20% protein diet) administered utilizing meal replacements.	Insulin Resistant Study Subjects

Measure	Description	Time Frame
Change in weight in kg		24 weeks

Measure	Description	Time Frame
Change in visceral fat via bioimpedance		24 weeks

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
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	Principal Investigator

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

ID	Term
D050528	Diet, Carbohydrate-Restricted
D018752	Diet, Fat-Restricted

ID	Term
D004035	Diet Therapy
D044623	Nutrition Therapy
D013812	Therapeutics
D004032	Diet
D009747

ID	Term
D009765	Obesity
D007333	Insulin Resistance
D024821	Metabolic Syndrome