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

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Dietary Supplement: Medically tailored meals

• Registration Number: NCT04523155
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-19
• Study First Submitted QC: 2020-08-19
• Study First Posted: 2020-08-21
• Study Start: 2020-08-24
• Primary Completion: 2021-06-04
• Study Completion: 2021-06-04
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-09
• Last Update Posted: 2021-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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%.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment Sequence AB	Medically tailored meals	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 Sequence BA	Medically tailored 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.

Primary Outcome Measures

Name	Time	Method
Change in Glucose Metabolism	Baseline, 3 monts	Measured by HbA1c levels in standard chemistry in blood

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States

Mayo Clinic; 🇺🇸 Jacksonville, Florida, United States