A Study to Evaluate the Effect of a Medically-tailored Meal Service on Changes in Diabetic Patients' A1c

Overview

About this study

Patients age 25 to 75 who are in the care of one of the primary care physicians at Mayo Clinic in Jacksonville, Florida or Montage Health in Monterey, California and have a recent HbA1c in the range of 7.5% to 13% will be prospectively identified and eligible for participation in this randomized, crossover clinical trial examining the effect of medically tailored meal delivery on glycemic control. Eligible patients who sign informed consent will be randomized in a 1:1 fashion to treatment sequence AB or treatment sequence BA. In the first study phase, 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. 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. Weight and blood pressure will be measured at weeks 0, 4, 8, 12, 24, 28, 32 and 36. During weeks 0, 12, 24 and 36 blood will be collected for measurement of lipids and glucose metabolism. Furthermore, a quality of life survey will be obtained during weeks 0, 12, 24 and 36. In addition, they will be asked to report how frequently they consumed the meals. During the study period participants will asked to keep a food diary to account for meals consumed that were not provided.

We hypothesize that there will be a greater 3-month improvement in HbA1c and other health parameters while receiving medically tailored meals compared to receiving no meals.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Jacksonville, Fla. Mayo Clinic principal investigator Bryan Farford, D.O.	Closed for enrollment

Mayo Clinic Location

Status

Jacksonville, Fla.

Mayo Clinic principal investigator

Bryan Farford, D.O.

Closed for enrollment

More information

Publications

Publications are currently not available

Clinical Trials