Recruiting

Diet Comparison

Sponsor:

Nutrisystem, Inc.

Code:

NCT01443143

Conditions

Type 2 Diabetes

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Portion-controlled diet

Usual Diet

Study Details

Brief summary:

This investigation will examine the effects of consuming a structured, portion-controlled, low-glycemic index diet (commercially available as the Nutrisystem-D program) on several indicators of glycemic stability and variability among participants with type 2 diabetes. Results on the portion-controlled diet will be compared with those on participants' usual diets in a randomized cross-over trial. The investigators expect that participants will exhibit greater glycemic stability (e.g., more time in euglycemic range) and less glycemic variability (e.g., smaller mean amplitude of glycemic excursions) while consuming the Nutrisystem D program, as compared with their usual diet.

Conditions

Type 2 Diabetes

Obesity

Study ID

NCT01443143

Start date

Dec, 2010

Status verified date

Sep, 2011

Completion date

Dec, 2011

Anticipated

Primary completion date

Dec, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosis of type 2 diabetes
  • Body mass index (BMI) of 27 to 45 kg/m2
  • Capacity to provide written informed consent
  • Willing and committed to return for all clinic visits and complete all study-related procedures
  • Men and women of all racial and ethnic groups are eligible for participation

Exclusion Criteria:

  • Use of hypoglycemic medications (e.g., sulfonylureas, insulin)
  • Food allergies or intolerances that would render adherence to the test diets unpleasant or unsafe
  • Use of anticoagulant medications (e.g., warfarin)
  • Pregnant or lactating
  • More than a 5% weight gain or loss within the last 3 months
  • More than one alcoholic drink per day
  • Binge eating disorder
  • Regular use of acetaminophen

Study Design

Enrollment

15 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Commercial diet

Commercially available diet program (i.e., Nutrisystem D) that includes pre-packaged low-glycemic index portion-controlled entrees and snacks that are supplemented with grocery items in accordance with a structured meal plan.

no intervention: Usual Diet

Participants' usual consumption of food and beverages.

Interventions

Portion-controlled diet

During this diet period, participants will consume portion-controlled products from the Nutrisystem-D program for three entrees and one (women) or two (men) snacks per day. These pre-packaged portion-controlled items will be supplemented with grocery additions (fruits, vegetables, and low-fat dairy items) to provide approximately 1300 (women) to 1500 (men) calories per day. The Nutrisystem-D program (i.e., provided foods plus grocery additions) provides approximately 53% of calories from carbohydrate, 22% of calories from fat (6% from saturated fat and 0% from trans fat), and 25% of calories from protein. Women and men on the program consume approximately 1800 and 2000 mg/d, respectively, of sodium, and 31 and 35 g/d, respectively, of fiber.

Usual Diet

During the usual diet period, participants will not be given any specific instructions about what they should or should not consume. Instead, they will be told to "Eat how you would normally eat if you were not in this study."

Primary outcome measure

  • Percent of time in euglycemic range [ Time Frame: 2 weeks ]

Central Contacts and Locations

Locations

University of Pennsylvania Center for Weight and Eating Disorders

Recruiting

Philadelphia, Pennsylvania, United States, 190104

Contacts

Dana Tioxon

215-573-7520tida@mail.med.upenn.edu

Louise Hesson, CRNP

215-898-7314lhesson@mail.med.upenn.edu

Principal Investigator:

Thomas A Wadden, Ph.D.

More Information

Sponsor

Nutrisystem, Inc.

Last update posted

Sep 29, 2011

Last verified

Sep, 2011

Keywords

  • Diabetes
  • Obesity
  • Glycemic
  • Portion-control
  • Commercial diet

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Nutrisystem, Inc. on 2011-09-29.