Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| PRV-08012V1.9 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Provident Clinical Research | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this pilot study is to assess adherence to a Novel Eating System (NES) with and without energy restriction.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NES With Energy Restriction | Active Comparator |
| |
| NES Without Energy Restriction | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NES With Energy Restriction | Behavioral | The NES will be administered based upon the individual's calculated daily energy requirement, with an energy deficit of approximately 500 kilocalories. |
| Measure | Description | 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 |
| Measure | Description | 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 | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kevin C Maki, PhD | Provident Clinical Research & Consulting, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Provident Clinical Research & Consulting, Inc. | Addison | Illinois | 60101 | United States | ||
| Provident Clinical Research & Consulting, Inc. |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| NES Without Energy Restriction | Behavioral | The NES will be administered based upon the individual's calculated daily energy requirement. |
|
| 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 |
| Bloomington |
| Indiana |
| 47403 |
| United States |