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

Mayo Clinic

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Dietary Supplement: Medically tailored meals

Study type: Interventional

Funder types: Other

Identifiers

NCT04523155

20-004608

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 25 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Treatment Sequence AB

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Medically tailored meals

Treatment Sequence BA

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Medically tailored meals