Type 2 DiabetesNCT04523155
Effect of Medically-tailored Meal Delivery Service on Changes in Hemoglobin A1c (HbA1c) in Patients With Diabetes
A study testing Medically tailored meals in people with Type 2 Diabetes, run by Mayo Clinic at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Medically tailored meals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Aug 2020to 4 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Mayo Clinic
Jacksonville, Florida, 32224
About this study
Official title: Effect of Medically-tailored Meal Delivery Service on Changes in Hemoglobin A1c (HbA1c) in Patients With Diabetes: A Randomized, Crossover Clinical Trial
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.
- Conditions
- Type 2 Diabetes
- Being tested
- Medically tailored meals
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medically tailored mealsDietary supplement
10 meals per week for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Treatment Sequence AB | Experimental | 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. Receives: Dietary Supplement: Medically tailored meals |
| Treatment Sequence BA | Experimental | 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. Receives: Dietary Supplement: Medically tailored meals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glucose Metabolism
Measured by HbA1c levels in standard chemistry in blood
Measured: Baseline, 3 monts
Secondary outcomes (5)
Change in Weight
Measured in killograms
Measured: Baseline, 3 months
Change in Blood Pressure
Measured in units of millimeters of mercury (mmHg)
Measured: Baseline, 3 months
Change in High Density lipoprotein (HDL)
HDL cholesterol levels measured by standard chemistry in blood reported in units of milligrams per deciliter (mg/dL)
Measured: Baseline, 3 months
Change in Low Density Lipoprotein (LDL)
LDL cholesterol levels measured by standard chemistry in blood reported in units of milligrams per deciliter (mg/dL)
Measured: Baseline, 3 months
Change in Triglycerides
Triglyceride levels measured by standard chemistry in blood reported in units of milligrams per deciliter (mg/dL)
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start24 Aug 2020
- Primary completion4 Jun 2021
- Study completion4 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bryan Farford, Mayo Clinic
- Investigators
- Bryan Farford, DO, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04523155
- Sponsor's protocol ID
- 20-004608
- Status last verified
- Jul 2021
- First submitted
- 19 Aug 2020
- Last updated
- 12 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Medically-tailored Meal Delivery Service on Changes in Hemoglobin A1c (HbA1c) in Patients With Diabetes: A Randomized, Crossover Clinical Trial
- ClinicalTrials.gov ID
- NCT04523155
- Acronym / sponsor ID
- 20-004608
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 24 Aug 2020 (actual)
- Primary completion
- 4 Jun 2021 (actual)
- Study completion
- 4 Jun 2021 (actual)
- First posted
- 21 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence AB | Experimental | Dietary Supplement: Medically tailored mealsParticipants 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 | Experimental | Dietary Supplement: Medically tailored mealsParticipants 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. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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%.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medically tailored meals10 meals per week for 3 months | Dietary supplement | Treatment Sequence AB, Treatment Sequence BA |
Primary outcome
Change in Glucose Metabolism
Time frame: Baseline, 3 monts
Measured by HbA1c levels in standard chemistry in blood
5 secondary outcomes
Change in Weight
Time frame: Baseline, 3 months
Change in Blood Pressure
Time frame: Baseline, 3 months
Change in High Density lipoprotein (HDL)
Time frame: Baseline, 3 months
Change in Low Density Lipoprotein (LDL)
Time frame: Baseline, 3 months
Change in Triglycerides
Time frame: Baseline, 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2021.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bryan Farford, DO principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medically tailored meals in people with Type 2 Diabetes, run by Mayo Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Glucose Metabolism (time frame: Baseline, 3 monts). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2021.