Dietary Changes for Chronic Kidney Disease

Overseen By Brandon Kistler

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Must not be taking: Metformin, Insulin, Immunosuppressants, Antibiotics

Disqualifiers: Diabetes, Hypertension, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to study how eating red meat affects certain toxins in the bodies of people with chronic kidney disease (CKD). Participants will follow two different diets: one including red meat and another vegetarian with eggs and dairy. The trial seeks men or postmenopausal women with stage 3 CKD (a moderate level of kidney disease) who can adhere to a controlled dietary intervention. As an unphased trial, this study offers participants the chance to contribute to important research that could enhance dietary recommendations for CKD patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've changed cardiovascular or hypertension medications in the last 30 days or if you've been treated with certain medications like metformin, insulin, or immunosuppressive drugs recently.

What prior data suggests that this dietary intervention is safe for people with chronic kidney disease?

Research has shown that eating a lot of red meat can harm kidney health. For people with chronic kidney disease (CKD), consuming too much red meat might lead to the buildup of harmful substances called uremic toxins, which occur when the kidneys aren't working well. Studies also suggest that replacing red meat with plant proteins can help prevent kidney problems from worsening.

Some evidence also links red meat to more heart issues in people with CKD. However, this trial includes a controlled diet, meaning researchers carefully monitor food intake, which can help reduce potential risks.

Participants should know that while red meat can be risky for those with CKD, the study is designed to closely watch and manage those risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for chronic kidney disease focus on medications or dialysis to manage symptoms and maintain kidney function. However, the dietary interventions in this trial offer a unique approach by potentially altering the progression of the disease through nutrition. Researchers are excited about these dietary changes because they explore how a lacto-ovo vegetarian diet and a variation that includes red meat as part of the protein intake can impact kidney health. By focusing on dietary proteins, this trial could reveal new ways to manage kidney health that go beyond traditional medical treatments.

What evidence suggests that this trial's dietary interventions could be effective for chronic kidney disease?

This trial will compare the effects of different diets on kidney health in people with chronic kidney disease (CKD). Participants in one arm of the trial will follow a lacto-ovo vegetarian diet, while those in another arm will have a diet where red meat replaces 20% of the protein. Research has shown that consuming a lot of red meat can harm kidney health in people with CKD. Several studies have found that a high intake of red meat increases the risk of CKD and may even lead to severe kidney failure. Red meat raises levels of waste products in the blood that the kidneys usually remove. These waste products can worsen kidney issues and increase the risk of heart disease. Overall, reducing red meat consumption might help protect kidney health. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults aged 40-70 with chronic kidney disease (CKD) stage 3, who are willing to follow a controlled diet and collect fecal samples at home. Men or postmenopausal women can join if they have an eGFR of 30-59ml/min/1.73m^2 or higher with significant albuminuria.

Inclusion Criteria

Willing to collect fecal samples at home

I am between 40 and 70 years old.

I am a man or a woman who has gone through menopause.

Exclusion Criteria

I have had cancer or cancer treatment in the past year, except for basal cell carcinoma.

I have taken antibiotics once in the last 3 months or twice in the last 6 months.

I haven't taken strong immune system medications or high-dose steroids recently.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants consume their typical, self-selected diet

2 weeks

Treatment

Participants follow a lacto-ovo vegetarian diet or the same diet with 20% of the protein replaced by red meat

3 weeks

Multiple collections in weeks 1, 2, 4, 5, 9, 10, 12, 13

Washout

Participants return to their typical, self-selected diet

5 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Controlled dietary intervention

Trial Overview The study tests the effects of replacing red meat in the diet on certain toxins in the blood and urine of people with CKD. Participants will consume a controlled diet provided by the researchers to see how it impacts their condition.

How Is the Trial Designed?

Group I: Red meat diet Experimental Treatment 1 Intervention

The lacto-ovo vegetarian diet with 20% of the protein replaced by red meat.

Group II: Lacto-ovo vegetarian diet Active Control 1 Intervention

A lacto-ovo vegetarian diet providing 0.8 g/kg/day of protein.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11978116/

Trends in the burden of chronic kidney disease related to high ... Multiple epidemiological studies consistently demonstrate a strong association between high red meat intake and adverse kidney outcomes, ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0899900717301971

Review Red meat intake in chronic kidney disease patients Red meat intake may lead to elevated production of uremic toxins and increased cardiovascular risk. •. High red meat intake is associated with increased risk ...

3. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2025.1666684/full

Global, regional, and national burden of chronic kidney ... Studies have shown that consuming higher amounts of red meat increases the risk of developing CKD and end-stage renal disease (10, 11). This increased risk may ...

4. nature.com nature.com/articles/s41598-024-59097-1

Consumption of red, white, and processed meat and odds ... The findings of the current case–control study indicated that higher consumption of red meat was associated with increased odds of DN, which ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6855949/

Diet and Chronic Kidney Disease - PMC Reducing animal protein intake and egg yolk and increasing intake of fruits and vegetables and fiber may prevent or delay end-stage renal disease.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7460905/

The Effects of High-Protein Diets on Kidney Health and ... Substituting one serving of red meat with a plant-based protein such as legumes was associated with a 31%–62.4% reduced risk of CKD. Table 3. Summary of ...

7. medicalnewstoday.com medicalnewstoday.com/articles/311664

Red meat consumption linked to kidney failure The researchers estimate that replacing one serving of red meat per week with a different protein source reduces the risk of developing ESRD by ...

8. researchgate.net researchgate.net/publication/390600936_Trends_in_the_burden_of_chronic_kidney_disease_related_to_high_red_meat_intake_from_1990_to_2021

(PDF) Trends in the burden of chronic kidney disease ... Conclusion The chronic kidney disease burden associated with high red meat intake demonstrated significant demographic and regional disparities, ...