Type 2 Diabetes Mellitus
Conditions
Keywords
diabetes, nutrition, diet, foods
Brief summary
The purpose of this pilot study is to assess adherence to a Novel Eating System (NES) with and without energy restriction.
Interventions
BEHAVIORALNES 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.
BEHAVIORALNES Without Energy Restriction
The NES will be administered based upon the individual's calculated daily energy requirement.
Sponsors
Provident Clinical Research
Mondelēz International, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| 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
| Measure | Time frame |
|---|---|
| Change in dietary macronutrient composition from baseline to end of treatment. | 10 weeks |
| 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 |
Countries
United States
Outcome results
None listed