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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00907075
• Other study ID #: PRV-08012
• Secondary ID: PRV-08012V1.9
• Status: Completed
• Phase: N/A
• First received: May 21, 2009
• Last updated: August 21, 2012
• Start date: March 2009
• Est. completion date: September 2009

Study information

• Verified date: August 2012
• Source: Mondelez International, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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.
• NES Without Energy Restriction
The NES will be administered based upon the individual's calculated daily energy requirement.

Locations

Country	Name	City	State
United States	Provident Clinical Research & Consulting, Inc.	Addison	Illinois
United States	Provident Clinical Research & Consulting, Inc.	Bloomington	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Mondelez International, Inc.	Provident Clinical Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in 24 hour mean circulating glucose level from baseline to end of treatment.		10 weeks	No
Secondary	Change in fasting plasma glucose and insulin from baseline to end of treatment.		10 weeks	No
Secondary	Change in lipid parameters (Total cholesterol, LDL-C, HDL-C, triglycerides) from baseline to end of treatment.		10 weeks	No
Secondary	Change in dietary macronutrient composition from baseline to end of treatment.		10 weeks	No