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| Name | Class |
|---|---|
| University of Freiburg | OTHER |
| University of Campinas, Brazil | OTHER |
| London Metropolitan University | OTHER |
| University of Mysore |
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A 12 month multi-center randomization controlled study. Participants will be randomized to either a lifestyle education program or a meal replacement regimen with Almased, after an initial examination of eligibility criteria.
Primary outcome-HbA1c
Age 21 + Male/Female gender Type 2 Diabetes Non-insulin dependent BMI 25-40 kg/m HbA1c 7.5-10%
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Almased Meal Replacement Powder | Experimental | Participants assigned to this arm will receive the Almased meal replacement powder and will be asked to replace one meal per day during the first 6 months of participation. During the second 6 months, participants will be allowed to choose whether to continue using the product to replace a meal or to use the product as a supplement prior to meals. |
|
| Lifestyle Intervention | Active Comparator | Participants randomized to this group will receive 5 group sessions in the first two months of participation and 5 additional group sessions in the last two months. These group sessions will focus on lifestyle behavior changes for weight loss and management including goal-setting, calorie balance, general nutrition, and physical activity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Almased Meal Replacement Powder | Dietary Supplement | Commercially available meal replacement product that contains soy protein, honey, yogurt, and amino acids. Participants assigned to this arm will receive the Almased meal replacement product and will be asked to replace one meal per day during the first 6 month. During the second 6 months, they will be allowed to choose to continue using the Almased as a meal replacement or to use it as a supplement prior to meals. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c (%) | 2, 4, 6, 8, 10, and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HOMA IR Index | measure changes in Homeostasis Model of Insulin Resistance | 2, 4, 6, 8, 10, and 12 months |
| Change in fasting blood glucose (mg/dl) | 2, 4, 6, 8, 10, and 12 months |
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Inclusion Criteria:• Gender: Men and women are eligible
Exclusion Criteria:• Unable or unwilling to give informed consent or communicate with local study staff;
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| Name | Affiliation | Role |
|---|---|---|
| Mara Z Vitolins, DrPH MPH RD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| OTHER |
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| Group-Based Lifestyle Intervention | Behavioral |
|
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |