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OpenTrials
Completed

NCT Number: NCT04523155

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic, Jacksonville, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for 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.

Treatment and study plan

Medically tailored meals

Dietary Supplement

10 meals per week for 3 months

Primary outcomes

  1. Change in Glucose Metabolism

    Time frame: Baseline, 3 monts

    Measured by HbA1c levels in standard chemistry in blood

Secondary outcomes

  1. Change in Weight

    Time frame: Baseline, 3 months

    Measured in killograms

  2. Change in Blood Pressure

    Time frame: Baseline, 3 months

    Measured in units of millimeters of mercury (mmHg)

  3. Change in High Density lipoprotein (HDL)

    Time frame: Baseline, 3 months

    HDL cholesterol levels measured by standard chemistry in blood reported in units of milligrams per deciliter (mg/dL)

  4. Change in Low Density Lipoprotein (LDL)

    Time frame: Baseline, 3 months

    LDL cholesterol levels measured by standard chemistry in blood reported in units of milligrams per deciliter (mg/dL)

  5. Change in Triglycerides

    Time frame: Baseline, 3 months

    Triglyceride levels measured by standard chemistry in blood reported in units of milligrams per deciliter (mg/dL)

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 21, 2020
Registry last updated
Jul 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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