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Pilot Study to Assess Adherence to a Novel Eating System in Men and Women With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00907075
First Posted: May 22, 2009
Last Update Posted: August 22, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Provident Clinical Research
Information provided by:
Mondelēz International, Inc.
  Purpose
The purpose of this pilot study is to assess adherence to a Novel Eating System (NES) with and without energy restriction.

Condition Intervention
Type 2 Diabetes Mellitus Behavioral: NES With Energy Restriction Behavioral: NES Without Energy Restriction

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study to Assess Adherence to a Novel Eating System in Men and Women With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Mondelēz International, Inc.:

Primary Outcome Measures:
  • Average percent deviations from the assigned eating system score for full days, meals, and snacks for each group during each evaluation period throughout the intervention (days 23-28 and days 51-56). [ Time Frame: 10 weeks ]

Secondary Outcome Measures:
  • Change in 24 hour mean circulating glucose level from baseline to end of treatment. [ Time Frame: 10 weeks ]
  • Change in fasting plasma glucose and insulin from baseline to end of treatment. [ Time Frame: 10 weeks ]
  • Change in lipid parameters (Total cholesterol, LDL-C, HDL-C, triglycerides) from baseline to end of treatment. [ Time Frame: 10 weeks ]
  • Change in dietary macronutrient composition from baseline to end of treatment. [ Time Frame: 10 weeks ]

Enrollment: 51
Study Start Date: March 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: NES With Energy Restriction Behavioral: NES With Energy Restriction
The NES will be administered based upon the individual's calculated daily energy requirement, with an energy deficit of approximately 500 kilocalories.
Active Comparator: NES Without Energy Restriction Behavioral: NES Without Energy Restriction
The NES will be administered based upon the individual's calculated daily energy requirement.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female, 18-79 years of age, inclusive.
  2. Diagnosis of type 2 diabetes, at least nine months prior to screening.
  3. Stable use of oral hypoglycemic medication for at least two months prior to screening.
  4. Body mass index (BMI) ≥25.0 and <45.0 kg/m2 at screening.
  5. Willingness to follow a novel eating plan, which may be energy restricted to promote weight loss, throughout the trial.

Exclusion Criteria:

  1. History or diagnosis of type 1 diabetes mellitus.
  2. Poorly controlled type 2 diabetes mellitus (HbA1C ≥9.0%).
  3. Weight loss or gain >10 lb (4.5 kg) in the two months prior to screening.
  4. Abnormal laboratory test results of clinical importance.
  5. History of gastrointestinal surgery for weight-reducing purposes.
  6. Poorly controlled hypertension.
  7. A clinically important medical or other condition.
  8. Any major trauma or major surgical event within three months of screening.
  9. Use of injected medications for glucose control within four weeks prior to screening.
  10. Use of weight loss medications, supplements, programs, or meal replacement products within two months of screening.
  11. Unstable use of foods, dietary supplements, herbals or medications, other than allowed medications, that have the potential to influence carbohydrate or lipid metabolism.
  12. Pregnancy
  13. Any history of extreme eating habits or an eating disorder diagnosed by a health professional.
  14. Recent history of (within 12 months of visit 1) or strong potential for alcohol or substance abuse.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00907075


Locations
United States, Illinois
Provident Clinical Research & Consulting, Inc.
Addison, Illinois, United States, 60101
United States, Indiana
Provident Clinical Research & Consulting, Inc.
Bloomington, Indiana, United States, 47403
Sponsors and Collaborators
Mondelēz International, Inc.
Provident Clinical Research
Investigators
Study Director: Kevin C Maki, PhD Provident Clinical Research & Consulting, Inc.
  More Information

Responsible Party: Richard Black, PhD/VP, Nutrition, Kraft Foods
ClinicalTrials.gov Identifier: NCT00907075     History of Changes
Other Study ID Numbers: PRV-08012
PRV-08012V1.9
First Submitted: May 21, 2009
First Posted: May 22, 2009
Last Update Posted: August 22, 2012
Last Verified: August 2012

Keywords provided by Mondelēz International, Inc.:
diabetes
nutrition
diet
foods

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases