Effect of Medically-tailored Meal Delivery Service on Changes in Hemoglobin A1c (HbA1c) in Patients With Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of medically-tailored meal delivery (10 meals per week for 3 months) on glycemic control in diabetic patients.

Official Title
-----------------
Effect of Medically-tailored Meal Delivery Service on Changes in Hemoglobin A1c (HbA1c) in Patients With Diabetes: A Randomized, Crossover Clinical Trial

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Dietary Supplement: Medically tailored meals


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult men and women with non-insulin dependent diabetes. Ages 25 to 75 years. Fasting blood sugar of greater than 140 mg/dl, on no oral hypoglycemic agents and a hemoglobin A1C less than 13%. Stabilized patients on oral hypoglycemic agents for one month or longer prior to starting the study and a hemoglobin A1C between 7.5% - 13%. Exclusion Criteria: Insulin use. Substance abuse. Any documented medical problem that would inhibit full participation in the study. BMI less than 25 or great than 40. Vegans or Vegetarians Individuals with food allergies. Individuals currently on a commercial weight loss or diet program.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Sequence AB<br>Participants randomized to sequence AB will receive 3 months of meals, followed by a 3 month washout period and a 3 month intervention period with no meals. | Dietary Supplement: Medically tailored meals<br>* 10 meals per week for 3 months<br>|
| Experimental: Treatment Sequence BA<br>Participants randomized to sequence BA will receive 3 months of no meals followed by a 3 month washout period and a 3 month intervention period with meals. | Dietary Supplement: Medically tailored meals<br>* 10 meals per week for 3 months<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Glucose Metabolism | Measured by HbA1c levels in standard chemistry in blood | Baseline, 3 monts | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Weight | Measured in killograms | Baseline, 3 months | 
| Change in Blood Pressure | Measured in units of millimeters of mercury (mmHg) | Baseline, 3 months | 
| Change in High Density lipoprotein (HDL) | HDL cholesterol levels measured by standard chemistry in blood reported in units of milligrams per deciliter (mg/dL) | Baseline, 3 months | 
| Change in Low Density Lipoprotein (LDL) | LDL cholesterol levels measured by standard chemistry in blood reported in units of milligrams per deciliter (mg/dL) | Baseline, 3 months | 
| Change in Triglycerides | Triglyceride levels measured by standard chemistry in blood reported in units of milligrams per deciliter (mg/dL) | Baseline, 3 months |