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

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT04523155
Collaborator
(none)
34
Enrollment
2
Locations
2
Arms
9.3
Actual Duration (Months)
17
Patients Per Site
1.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Medically tailored meals
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Effect of Medically-tailored Meal Delivery Service on Changes in Hemoglobin A1c (HbA1c) in Patients With Diabetes: A Randomized, Crossover Clinical Trial
Actual Study Start Date :
Aug 24, 2020
Actual Primary Completion Date :
Jun 4, 2021
Actual Study Completion Date :
Jun 4, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment Sequence AB

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
10 meals per week for 3 months
Experimental: Treatment Sequence BA

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
10 meals per week for 3 months

Outcome Measures

Primary Outcome Measures

  1. Change in Glucose Metabolism [Baseline, 3 monts]

    Measured by HbA1c levels in standard chemistry in blood

Secondary Outcome Measures

  1. Change in Weight [Baseline, 3 months]

    Measured in killograms

  2. Change in Blood Pressure [Baseline, 3 months]

    Measured in units of millimeters of mercury (mmHg)

  3. 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)

  4. 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)

  5. Change in Triglycerides [Baseline, 3 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic in Florida Jacksonville Florida United States 32224
2 Mayo Clinic Jacksonville Florida United States 32224

Sponsors and Collaborators

  • Mayo Clinic

Investigators

  • Principal Investigator: Bryan Farford, DO, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Bryan Farford, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT04523155
Other Study ID Numbers:
  • 20-004608
First Posted:
Aug 21, 2020
Last Update Posted:
Jul 12, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Diabetes Mellitus

Study Results

No Results Posted as of Jul 12, 2021