Chronic Kidney DiseaseFAME-CKDNCT07759401
Food As Medicine to Reduce CKD Burden in Health Disparity Populations
A study testing Culinary Medicine Nutrition and Cooking Education in people with Chronic Kidney Disease, run by University of Texas Southwestern Medical Center at 2 sites in United States.
Trial summary
Healthy eating plays an important role in kidney and heart health, and programs that use food as medicine can help improve diet and overall health, but the best ways to support healthy eating in community settings are not well understood. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Culinary Medicine Nutrition and Cooking Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2026to Oct 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men and women of age ≥ 18 years and able to give consent;
- willingness to participate in a 12-month study;
- elevated albumin to creatinine ratio (ACR) (≥ 30 mg/g) determined by point-of-care urine dipstick during health screen;
- Reside in a low-income area or visit a food pantry due to food insecurity
Who cannot join
- whose urine dipstick does not indicate micro- or macro-albuminuria (ACR <30 mg/g),
- currently receiving dialysis or need dialysis,
- have received or need a kidney transplant,
- pregnant or plan to become pregnant in the next 12 months,
- baseline urine potassium > 60 mEq/g creatinine (baseline excretion below this level was not associated with hyperkalemia when fruit/vegetable were paired with kidney-protective drugs,
- urine ACR values indicate nephrotic proteinuria, and
- CKD stage 5 demonstrated by elevated estimated glomerular filtration rate (eGFR) obtained during baseline measures.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Brother Bill's Helping Hand
Dallas, Texas, 75212
Wes Keyes, 214-638-2196, wes.keyes@bbhh.org
University of Texas Southwestern
Dallas, Texas, 75390
Emilie Ruiz, BS, 469-285-6848, emilie.ruiz@utsouthwestern.edu
About this study
Healthy eating plays an important role in kidney and heart health, and programs that use food as medicine can help improve diet and overall health, but the best ways to support healthy eating in community settings are not well understood. The purpose of this study is to compare two study groups to see which is more effective at improving kidney health and related health outcomes in adults with chronic kidney disease. One group receives fruits and vegetables with cooking education, and the other receives fruits and vegetables alone. The results may help researchers develop community-based programs to improve kidney and heart health, especially in populations at higher risk for kidney disease.
If the participant joins the study, the participant will complete a baseline visit, a 6-month visit, and a 12-month visit. Visits include questionnaires about the participant's health, diet, and cooking habits; a urine sample; a blood sample; blood pressure, height, weight, and waist measurements; and a brief, painless Veggie Meter® scan to measure fruit and vegetable intake. Participants will pick up weekly fruits and vegetables for 12 months. Those in the cooking group will also attend 12 weekly cooking and nutrition classes and receive follow-up newsletters and optional monthly virtual sessions. Depending on the group to which the participants are assigned, the total time commitment for the participants in this study will range from approximately 3 to 15 hours.
Participation is voluntary, involves minimal risk, and all information will be kept private. Possible risks include brief pain or bruising from the blood draw, mild discomfort from urine collection, minor risk of cuts or burns during cooking, and some questions may feel personal; the participant may skip any question. There may be no direct benefit to the participant, but the participant's participation may help improve nutrition and kidney health programs in the community.
Read the detailed description
Chronic kidney disease (CKD) impacts approximately 1/7 Americans, who experience asymptomatic progressive CKD leading to catastrophic complications, including kidney failure and death, and this R01 study will extend our previous R21 work to screen, identify , and intervene with culinary medicine philosophy within a community-based setting. The overall goals of the research study are to evaluate (1) urine albumin to creatinine ratio outcomes, (2) secondary endpoints including cardiovascular disease (CVD) measurements (i.e., systolic and diastolic blood pressure, body mass index, hemoglobin A1c, lipids), and (3) dietary adherence and change as well as nutrition knowledge and efficacy. This work will determine whether base-producing fruit and vegetables with or without culinary medicine improves CKD outcomes and associated CVD risk in lower socioeconomic community settings to inform future multi-site trials and population level implementation .
- Conditions
- Chronic Kidney Disease
- Being tested
- Culinary Medicine Nutrition and Cooking Education
- Keywords
- Chronic Kidney Disease, CKD, Food is Medicine
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culinary Medicine Nutrition and Cooking EducationBehavioural
A 12-week group-based culinary medicine program integrating nutrition education, cooking instruction, and behavior change strategies to support healthy eating and meal preparation.
| Study group | Role | What they receive |
|---|---|---|
| Fruits and Vegetables (FV) Only (Control) | No intervention | This group will receive a prescribed amount of free (at no charge) base-producing FV for 12 months through pick-up at one of two Brother Bills Helping Hand (BBHH) sites. BBHH clients pick up groceries weekly from either their main West Dallas campus or the South Dallas Community Market. This calculated FV amount averages 2-3 cups of base-producing FV daily. The FV Only group is considered standard care. |
| Fruits and Vegetables + Nutrition and Cooking education | Experimental | Participants will receive the same free base-producing as the FV Only group plus 12 weekly group nutrition and cooking education classes delivered through the UTSW Culinary Medicine program. Classes include hands-on cooking instruction, nutrition education, goal setting, behavioral strategies, and skill-building activities designed to improve healthy eating behaviors, self-efficacy, and motivation. Receives: Behavioral: Culinary Medicine Nutrition and Cooking Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Urine Albumin to Creatinine Ratio at 6 months
Diagnostic laboratory results for urinalysis will determine whether urine albumin-to-creatinine ratio (UACR) is reduced to a greater extent with the FV + Cook intervention as compared to FV Only at 6- months. High levels of urine albumin excretion predict increased risk for subsequent eGFR decline and its change during follow up is directly associated with risk for End-Stage Kidney Disease (ESKD).
Measured: Baseline (enrollment), 6 months
Change in Urine Albumin to Creatinine Ratio at 12 months
Diagnostic laboratory results for urinalysis will determine whether urine albumin-to-creatinine ratio (UACR) is reduced to a greater extent with the FV + Cook intervention as compared to FV Only at 12-months. High levels of urine albumin excretion predict increased risk for subsequent eGFR decline and its change during follow up is directly associated with risk for ESKD.
Measured: Baseline (enrollment), 12 months
Secondary outcomes (12)
Change from Baseline in Systolic and Diastolic Blood Pressure at 6 months
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) will be measured in millimeters of mercury (mmHg) using a validated instrument according to standardized guidelines. Two to three consecutive readings will be obtained and averaged for analysis.
The outcome will be expressed as the mean change from baseline in SBP and DBP at the specified timepoint.
Measured: Baseline (enrollment), 6 months
Change from Baseline in Systolic and Diastolic Blood Pressure at 12 Months
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) will be measured in millimeters of mercury (mmHg) using a validated instrument according to standardized guidelines. Two to three consecutive readings will be obtained and averaged for analysis.
The outcome will be expressed as the mean change from baseline in SBP and DBP at the specified timepoint.
Measured: Baseline (enrollment), 12 months
Change from Baseline in Glycated Hemoglobin (HbA1c) at 6 months
HbA1c will be measured as a percentage (%) from venous blood samples using a standardized laboratory method.
The outcome will be expressed as the mean change from baseline in HbA1c at the specified timepoint.
Measured: Baseline (enrollment), 6 Months
Change from Baseline in Glycated Hemoglobin (HbA1c) at 12 Months
HbA1c will be measured as a percentage (%) from venous blood samples using a standardized laboratory method.
The outcome will be expressed as the mean change from baseline in HbA1c at the specified timepoint.
Measured: Baseline (enrollment), 12 months
Change from Baseline in Body Mass Index (BMI) at 6 Months
Body mass index (BMI) will be calculated as weight in kilograms divided by height in meters squared (kg/m²). Body weight and height will be measured using standardized procedures, with weight measured using a calibrated scale and height using a stadiometer.
The outcome will be expressed as the mean change from baseline in BMI at the specified timepoint.
Measured: Baseline (enrollment), 6 Months
Change from Baseline in Body Mass Index (BMI) at 12 Months
Body mass index (BMI) will be calculated as weight in kilograms divided by height in meters squared (kg/m²). Body weight and height will be measured using standardized procedures, with weight measured using a calibrated scale and height using a stadiometer.
The outcome will be expressed as the mean change from baseline in BMI at the specified timepoint.
Measured: Baseline (enrollment), 12 months
Change in LDL Cholesterol (LDL-C) Level From Baseline to 6 months
LDL cholesterol concentration measured in fasting blood samples using a validated clinical laboratory assay. The outcome is defined as the mean change in LDL-C (mg/dL or mmol/L) from baseline to 6 months. A reduction in LDL-C from baseline indicates improvement.
Measured: Baseline (enrollment), 6 Months
Change in LDL Cholesterol (LDL-C) Level From Baseline to 12 Months
LDL cholesterol concentration measured in fasting blood samples using a validated clinical laboratory assay. The outcome is defined as the mean change in LDL-C (mg/dL or mmol/L) from baseline to 12 months. A reduction in LDL-C from baseline indicates improvement.
Measured: Baseline (enrollment), 12 months
Change in HDL Cholesterol (HDL-C) Level From Baseline to 6 months
HDL cholesterol concentration measured in fasting blood samples using a validated clinical laboratory assay. The outcome is defined as the mean change in HDL-C (mg/dL or mmol/L) from baseline to 6 months. An increase in HDL-C from baseline indicates improvement.
Measured: Baseline (enrollment), 6 Months
Change in HDL Cholesterol (HDL-C) Level From Baseline to 12 Months
HDL cholesterol concentration measured in fasting blood samples using a validated clinical laboratory assay. The outcome is defined as the mean change in HDL-C (mg/dL or mmol/L) from baseline to 12 months. An increase in HDL-C from baseline indicates improvement.
Measured: Baseline (enrollment), 12 months
Change in Lipoprotein(a) [Lp(a)] Level From Baseline to 6 months
Serum lipoprotein(a) concentration measured using a validated laboratory assay. The outcome is defined as the mean change in Lp(a) level (nmol/L or mg/dL) from baseline to 6 months. A reduction in Lp(a) concentration from baseline indicates improvement.
Measured: Baseline (enrollment), 6 Months
Change in Lipoprotein(a) [Lp(a)] Level From Baseline to 12 Months
Serum lipoprotein(a) concentration measured using a validated laboratory assay. The outcome is defined as the mean change in Lp(a) level (nmol/L or mg/dL) from baseline to 6 months. A reduction in Lp(a) concentration from baseline indicates improvement.
Measured: Baseline (enrollment), 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2031 (estimated)
- Study completionOct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Messiah, University of Texas Southwestern Medical Center
- Investigators
- Sarah Messiah, PhD, Principal investigator, University of Texas Southwestern Medical CenterHeather Kitzman, PhD, Principal investigator, Parkland HealthDonald Wesson, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07759401
- Sponsor's protocol ID
- STU20260055
- Other IDs
- 1R01DK143078-01A1
- Acronym
- FAME-CKD
- Status last verified
- Aug 2026
- First submitted
- 20 Jul 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD sharing will not be shared with other researchers. Only aggregated, de-identified data will be shared if needed.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food As Medicine to Reduce CKD Burden in Health Disparity Populations
- ClinicalTrials.gov ID
- NCT07759401
- Acronym / sponsor ID
- FAME-CKD / STU20260055
- Conditions
- Chronic Kidney Disease
- Keywords
- Chronic Kidney Disease, CKD, Food is Medicine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2031 (estimated)
- Study completion
- Oct 2032 (estimated)
- First posted
- 12 Aug 2026 (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.
Healthy eating plays an important role in kidney and heart health, and programs that use food as medicine can help improve diet and overall health, but the best ways to support healthy eating in community settings are not well understood. The purpose of this study is to compare two study groups to see which is more effective at improving kidney health and related health outcomes in adults with chronic kidney disease. One group receives fruits and vegetables with cooking education, and the other receives fruits and vegetables alone. The results may help researchers develop community-based programs to improve kidney and heart health, especially in populations at higher risk for kidney disease.
If the participant joins the study, the participant will complete a baseline visit, a 6-month visit, and a 12-month visit. Visits include questionnaires about the participant's health, diet, and cooking habits; a urine sample; a blood sample; blood pressure, height, weight, and waist measurements; and a brief, painless Veggie Meter® scan to measure fruit and vegetable intake. Participants will pick up weekly fruits and vegetables for 12 months. Those in the cooking group will also attend 12 weekly cooking and nutrition classes and receive follow-up newsletters and optional monthly virtual sessions. Depending on the group to which the participants are assigned, the total time commitment for the participants in this study will range from approximately 3 to 15 hours.
Participation is voluntary, involves minimal risk, and all information will be kept private. Possible risks include brief pain or bruising from the blood draw, mild discomfort from urine collection, minor risk of cuts or burns during cooking, and some questions may feel personal; the participant may skip any question. There may be no direct benefit to the participant, but the participant's participation may help improve nutrition and kidney health programs in the community.
Detailed description
Chronic kidney disease (CKD) impacts approximately 1/7 Americans, who experience asymptomatic progressive CKD leading to catastrophic complications, including kidney failure and death, and this R01 study will extend our previous R21 work to screen, identify , and intervene with culinary medicine philosophy within a community-based setting. The overall goals of the research study are to evaluate (1) urine albumin to creatinine ratio outcomes, (2) secondary endpoints including cardiovascular disease (CVD) measurements (i.e., systolic and diastolic blood pressure, body mass index, hemoglobin A1c, lipids), and (3) dietary adherence and change as well as nutrition knowledge and efficacy. This work will determine whether base-producing fruit and vegetables with or without culinary medicine improves CKD outcomes and associated CVD risk in lower socioeconomic community settings to inform future multi-site trials and population level implementation .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fruits and Vegetables (FV) Only (Control) | No intervention | –This group will receive a prescribed amount of free (at no charge) base-producing FV for 12 months through pick-up at one of two Brother Bills Helping Hand (BBHH) sites. BBHH clients pick up groceries weekly from either their main West Dallas campus or the South Dallas Community Market. This calculated FV amount averages 2-3 cups of base-producing FV daily. The FV Only group is considered standard care. |
| Fruits and Vegetables + Nutrition and Cooking education | Experimental | Behavioral: Culinary Medicine Nutrition and Cooking EducationParticipants will receive the same free base-producing as the FV Only group plus 12 weekly group nutrition and cooking education classes delivered through the UTSW Culinary Medicine program. Classes include hands-on cooking instruction, nutrition education, goal setting, behavioral strategies, and skill-building activities designed to improve healthy eating behaviors, self-efficacy, and motivation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- men and women of age ≥ 18 years and able to give consent;
- willingness to participate in a 12-month study;
- elevated albumin to creatinine ratio (ACR) (≥ 30 mg/g) determined by point-of-care urine dipstick during health screen;
- Reside in a low-income area or visit a food pantry due to food insecurity
Key exclusion criteria (7 listed)
- whose urine dipstick does not indicate micro- or macro-albuminuria (ACR <30 mg/g),
- currently receiving dialysis or need dialysis,
- have received or need a kidney transplant,
- pregnant or plan to become pregnant in the next 12 months,
- baseline urine potassium > 60 mEq/g creatinine (baseline excretion below this level was not associated with hyperkalemia when fruit/vegetable were paired with kidney-protective drugs,
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 |
|---|---|---|
| Culinary Medicine Nutrition and Cooking EducationA 12-week group-based culinary medicine program integrating nutrition education, cooking instruction, and behavior change strategies to support healthy eating and meal preparation. | Behavioural | Fruits and Vegetables + Nutrition and Cooking education |
Primary outcome
Change from Baseline in Urine Albumin to Creatinine Ratio at 6 months
Time frame: Baseline (enrollment), 6 months
Diagnostic laboratory results for urinalysis will determine whether urine albumin-to-creatinine ratio (UACR) is reduced to a greater extent with the FV + Cook intervention as compared to FV Only at 6- months. High levels of urine albumin excretion predict increased risk for subsequent eGFR decline and its change during follow up is directly associated with risk for End-Stage Kidney Disease (ESKD).
Change in Urine Albumin to Creatinine Ratio at 12 months
Time frame: Baseline (enrollment), 12 months
Diagnostic laboratory results for urinalysis will determine whether urine albumin-to-creatinine ratio (UACR) is reduced to a greater extent with the FV + Cook intervention as compared to FV Only at 12-months. High levels of urine albumin excretion predict increased risk for subsequent eGFR decline and its change during follow up is directly associated with risk for ESKD.
12 secondary outcomes
Change from Baseline in Systolic and Diastolic Blood Pressure at 6 months
Time frame: Baseline (enrollment), 6 months
Change from Baseline in Systolic and Diastolic Blood Pressure at 12 Months
Time frame: Baseline (enrollment), 12 months
Change from Baseline in Glycated Hemoglobin (HbA1c) at 6 months
Time frame: Baseline (enrollment), 6 Months
Change from Baseline in Glycated Hemoglobin (HbA1c) at 12 Months
Time frame: Baseline (enrollment), 12 months
Change from Baseline in Body Mass Index (BMI) at 6 Months
Time frame: Baseline (enrollment), 6 Months
Change from Baseline in Body Mass Index (BMI) at 12 Months
Time frame: Baseline (enrollment), 12 months
Change in LDL Cholesterol (LDL-C) Level From Baseline to 6 months
Time frame: Baseline (enrollment), 6 Months
Change in LDL Cholesterol (LDL-C) Level From Baseline to 12 Months
Time frame: Baseline (enrollment), 12 months
Change in HDL Cholesterol (HDL-C) Level From Baseline to 6 months
Time frame: Baseline (enrollment), 6 Months
Change in HDL Cholesterol (HDL-C) Level From Baseline to 12 Months
Time frame: Baseline (enrollment), 12 months
Change in Lipoprotein(a) [Lp(a)] Level From Baseline to 6 months
Time frame: Baseline (enrollment), 6 Months
Change in Lipoprotein(a) [Lp(a)] Level From Baseline to 12 Months
Time frame: Baseline (enrollment), 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No. IPD sharing will not be shared with other researchers. Only aggregated, de-identified data will be shared if needed.
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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.
Sarah Messiah, PhD principal investigator
University of Texas Southwestern Medical Center
Heather Kitzman, PhD principal investigator
Parkland Health
Donald Wesson, MD principal investigator
University of Texas Southwestern Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culinary Medicine Nutrition and Cooking Education in people with Chronic Kidney Disease, run by University of Texas Southwestern Medical Center 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: opening soon, as of the sponsor's last update on 12 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emilie Ruiz, BS (469-285-6848, emilie.ruiz@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Urine Albumin to Creatinine Ratio at 6 months (time frame: Baseline (enrollment), 6 months). The study lists 2 primary outcomes in all. 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 Aug 2026.