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

The purpose of this pilot study is to assess adherence to a Novel Eating System (NES) with and without energy restriction.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Behavioral: NES With Energy Restriction; Behavioral: NES Without Energy Restriction

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Addison, Illinois, United States, 60101
      • Provident Clinical Research & Consulting, Inc.
  • Indiana
    • Bloomington, Indiana, United States, 47403
      • Provident Clinical Research & Consulting, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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).	10 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mondelēz International, Inc.
• Collaborators: Provident Clinical Research
• Investigators: Study Director: Kevin C Maki, PhD, Provident Clinical Research & Consulting, Inc.

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (ACTUAL): September 1, 2009
• Study Completion (ACTUAL): September 1, 2009

Study Registration Dates

• First Submitted: May 21, 2009
• First Submitted That Met QC Criteria: May 21, 2009
• First Posted (ESTIMATE): May 22, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): August 22, 2012
• Last Update Submitted That Met QC Criteria: August 21, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: diabetes; nutrition; diet; foods
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: PRV-08012; PRV-08012V1.9