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NCT Number: NCT07759401

Food As Medicine to Reduce CKD Burden in Health Disparity Populations

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.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brother Bill's Helping Hand, Dallas, Texas, United States

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About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Culinary Medicine Nutrition and Cooking Education

Behavioral

A 12-week group-based culinary medicine program integrating nutrition education, cooking instruction, and behavior change strategies to support healthy eating and meal preparation.

Primary outcomes

  1. 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).

  2. 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.

Secondary outcomes

  1. Change from Baseline in Systolic and Diastolic Blood Pressure at 6 months

    Time frame: Baseline (enrollment), 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.

  2. Change from Baseline in Systolic and Diastolic Blood Pressure at 12 Months

    Time frame: Baseline (enrollment), 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.

  3. Change from Baseline in Glycated Hemoglobin (HbA1c) at 6 months

    Time frame: Baseline (enrollment), 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.

  4. Change from Baseline in Glycated Hemoglobin (HbA1c) at 12 Months

    Time frame: Baseline (enrollment), 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.

  5. Change from Baseline in Body Mass Index (BMI) at 6 Months

    Time frame: Baseline (enrollment), 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.

  6. Change from Baseline in Body Mass Index (BMI) at 12 Months

    Time frame: Baseline (enrollment), 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.

  7. Change in LDL Cholesterol (LDL-C) Level From Baseline to 6 months

    Time frame: Baseline (enrollment), 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.

  8. Change in LDL Cholesterol (LDL-C) Level From Baseline to 12 Months

    Time frame: Baseline (enrollment), 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.

  9. Change in HDL Cholesterol (HDL-C) Level From Baseline to 6 months

    Time frame: Baseline (enrollment), 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.

  10. Change in HDL Cholesterol (HDL-C) Level From Baseline to 12 Months

    Time frame: Baseline (enrollment), 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.

  11. Change in Lipoprotein(a) [Lp(a)] Level From Baseline to 6 months

    Time frame: Baseline (enrollment), 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.

  12. Change in Lipoprotein(a) [Lp(a)] Level From Baseline to 12 Months

    Time frame: Baseline (enrollment), 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.

Other outcomes

  1. Change in Dietary Intake [total energy intake (kcal/day)]

    Time frame: Baseline (enrollment), 6 months

    Mean daily energy intake calculated from dietary assessment data and expressed as kilocalories per day.

  2. Change in Dietary Intake [total energy intake (kcal/day)]

    Time frame: Baseline (enrollment), 12 months

    Mean daily energy intake calculated from dietary assessment data and expressed as kilocalories per day.

  3. Change in Dietary Intake [total fat intake (g/day)]

    Time frame: Baseline (enrollment), 6 months

    Mean daily total fat intake calculated from dietary assessment data and expressed as grams per day.

  4. Change in Dietary Intake [total fat intake (g/day)]

    Time frame: Baseline (enrollment), 12 months

    Mean daily total fat intake calculated from dietary assessment data and expressed as grams per day.

  5. Change in Dietary Intake [added sugar intake (g/day)]

    Time frame: Baseline (enrollment), 6 months

    Mean daily added sugar intake calculated from dietary assessment data and expressed as grams per day.

  6. Change in Dietary Intake [added sugar intake (g/day)]

    Time frame: Baseline (enrollment), 12 months

    Mean daily added sugar intake calculated from dietary assessment data and expressed as grams per day.

  7. Change in Dietary Intake [sodium intake (mg/day)]

    Time frame: Baseline (enrollment), 6 months

    Mean daily sodium intake calculated from dietary assessment data and expressed as milligrams per day.

  8. Change in Dietary Intake [sodium intake (mg/day)]

    Time frame: Baseline (enrollment), 12 months

    Mean daily sodium intake calculated from dietary assessment data and expressed as milligrams per day.

  9. Change in Dietary Intake [fruit and vegetable consumption (servings/day)]

    Time frame: Baseline (enrollment), 6 months

    Average daily servings of fruits and vegetables derived from dietary assessment data.

  10. Change in Dietary Intake [fruit and vegetable consumption (servings/day)]

    Time frame: Baseline (enrollment), 12 months

    Average daily servings of fruits and vegetables derived from dietary assessment data.

  11. Change in Dietary Intake [selected macro- and micronutrient intake]

    Time frame: Baseline (enrollment), 6 months

    Mean daily intake of selected nutrients, including carbohydrates, protein, fiber, vitamins, and minerals, calculated from dietary assessment data and expressed in standard units (g/day, mg/day, or µg/day, as appropriate).

  12. Change in Dietary Intake [selected macro- and micronutrient intake]

    Time frame: Baseline (enrollment), 12 months

    Mean daily intake of selected nutrients, including carbohydrates, protein, fiber, vitamins, and minerals, calculated from dietary assessment data and expressed in standard units (g/day, mg/day, or µg/day, as appropriate).

  13. Change in Dietary quality

    Time frame: Baseline (enrollment), 6 months

    Diet quality will be calculated from ASA24 dietary recall data using the Diet Quality Index-International (DQI-I). Both the total (summative) DQI-I score and mean DQI-I score will be analyzed, with higher scores indicating better overall diet quality.

  14. Change in Dietary quality

    Time frame: Baseline (enrollment), 12 months

    Diet quality will be calculated from ASA24 dietary recall data using the Diet Quality Index-International (DQI-I). Both the total (summative) DQI-I score and mean DQI-I score will be analyzed, with higher scores indicating better overall diet quality.

  15. Change in skin carotenoid status

    Time frame: Baseline (enrollment), 6 months

    Skin carotenoid status measured by noninvasive spectroscopy. Higher scores indicate greater carotenoid status and are associated with higher fruit and vegetable intake and better overall diet quality.

  16. Change in skin carotenoid status

    Time frame: Baseline (enrollment), 12 months

    Skin carotenoid status measured by noninvasive spectroscopy. Higher scores indicate greater carotenoid status and are associated with higher fruit and vegetable intake and better overall diet quality.

Study contacts

Contact information is provided by the study sponsor or research team.

Emilie Ruiz, BS

CONTACT

[email protected]

469-285-6848

Meera J. Patel, PhD

CONTACT

[email protected]

469-852-8557

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Acronym: FAME-CKD

Important dates

Study start
2026
Primary completion
2031
Study completion
2032
First posted
Aug 12, 2026
Registry last updated
Aug 12, 2026

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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