Almased Multi-Center Diabetes Intervention Trial (AMDIT)
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|ClinicalTrials.gov Identifier: NCT01702012|
Recruitment Status : Completed
First Posted : October 5, 2012
Last Update Posted : January 31, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Obesity||Dietary Supplement: Almased Meal Replacement Powder Behavioral: Group-Based Lifestyle Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Evaluation of Almased on Glycemic Control and Metabolic Effects in Patients With Type 2 Diabetes|
|Actual Study Start Date :||January 2013|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||May 2015|
Experimental: Almased Meal Replacement Powder
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.
Dietary Supplement: Almased Meal Replacement Powder
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.
Active Comparator: Lifestyle Intervention
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.
Behavioral: Group-Based Lifestyle Intervention
- Change in HbA1c (%) [ Time Frame: 2, 4, 6, 8, 10, and 12 months ]
- Change in HOMA IR Index [ Time Frame: 2, 4, 6, 8, 10, and 12 months ]measure changes in Homeostasis Model of Insulin Resistance
- Change in fasting blood glucose (mg/dl) [ Time Frame: 2, 4, 6, 8, 10, and 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01702012
|United States, North Carolina|
|Wake Forest University Health Sciences|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Mara Z Vitolins, DrPH MPH RD||Wake Forest University Health Sciences|