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

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Behavioral: NES With Energy Restriction; Behavioral: NES Without Energy Restriction

• Registration Number: NCT00907075
• Lead Sponsor: Mondelēz International, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-05-21
• Study First Submitted QC: 2009-05-21
• Study First Posted: 2009-05-22
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-21
• Last Update Posted: 2012-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NES With Energy Restriction	NES With Energy Restriction	-
NES Without Energy Restriction	NES Without Energy Restriction	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Provident Clinical Research & Consulting, Inc.; 🇺🇸 Bloomington, Indiana, United States