Diet Modification for Chronic Kidney Disease

(ReDACKD Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Karthik Tennankore, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Dylan MacKay

Must not be taking: Potassium binders

Disqualifiers: Dialysis, COPD, Heart failure, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing if home-delivered fruits and vegetables can help manage metabolic acidosis in patients with chronic kidney disease. These patients often do not respond well to usual care. The fruits and vegetables help by reducing the acid levels in the body, which may slow down kidney damage. Recent studies have shown that base-producing fruits and vegetables might yield better health outcomes for CKD patients compared to usual care.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are currently on potassium binding therapy, you cannot participate in the trial.

What data supports the effectiveness of the treatment Alkalizing Fruit and Vegetables, Dietary Alkali, Alkaline Foods, Sodium bicarbonate, Baking soda, Sodium hydrogen carbonate for chronic kidney disease?

Research shows that using base-producing fruits and vegetables can improve heart health and reduce kidney damage in people with chronic kidney disease, similar to the effects of sodium bicarbonate. This approach may also be more cost-effective and better tolerated by patients. ^{1 2 3 4 5}

Is the diet modification treatment for chronic kidney disease safe for humans?

Research suggests that using fruits and vegetables to reduce dietary acid is generally safe and can help protect kidney function in people with chronic kidney disease. However, sodium bicarbonate, another treatment option, may not be well tolerated by some people due to its sodium content. ^{1 2 3 5 6}

How is the treatment with alkalizing fruits and vegetables different from other treatments for chronic kidney disease?

This treatment is unique because it uses base-producing fruits and vegetables to reduce acid levels in the body, which can improve health outcomes and reduce cardiovascular risk better than the standard sodium bicarbonate treatment. It offers a more natural and potentially more tolerable alternative to traditional oral alkali therapy. ^{1 3 4 5 6}

Research Team

Navdeep Tangri, MD, PhD

Principal Investigator

Seven Oaks General Hospital Chronic Disease Innovation Centre

Dylan MacKay, PhD

Principal Investigator

George and Fay Yee Centre for Healthcare Innovation

Karthik Tennankore, MD

Principal Investigator

Nova Scotia Health Authority

Eligibility Criteria

The ReDACKD trial is for adults with chronic kidney disease who are not pregnant, haven't had a recent heart attack or stroke, and don't have severe heart failure or lung disease requiring oxygen. They should be able to eat fruits and vegetables without difficulty, have certain levels of blood markers within specific ranges, and not be on dialysis.

Inclusion Criteria

I am 18 years old or older.

Participant is willing and able to give informed consent for participation in the trial

Participants are able to communicate in English and provide written informed consent

Exclusion Criteria

I am currently taking medication to manage my potassium levels.

I cannot swallow pills or have digestive issues that prevent me from taking certain medications.

I am currently pregnant or breastfeeding.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either alkalizing fruits and vegetables via home delivery or oral sodium bicarbonate for 12 months

12 months

Monthly visits for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Treatment Details

Interventions

• Alkalizing Fruit and Vegetables (Dietary Supplement)
• Sodium bicarbonate (Buffering Agent)

Trial Overview This study tests if eating alkalizing fruits and vegetables can manage metabolic acidosis better than the usual treatment with sodium bicarbonate pills in people with chronic kidney disease. Participants will receive these foods delivered to their homes to see if this approach improves their condition.

Participant Groups

Group I: Alkalizing Fruit and Vegetables Experimental Treatment 1 Intervention

Participants randomized to fruit and vegetables (F+V) will receive weekly supplementation of alkalizing fruits and vegetables via home delivery in a box format. Participants will receive a 1-hour dietary counseling session from a registered dietitian (RD), following randomization, either in person or via videoconference, depending on regional coronavirus disease (COVID) 19 restrictions and participant preference, which will outline the concepts of the dietary intervention. The RD will also recommend the best ways to prepare and include the F+V into the participant's current diet. Intervention will last 12 months.

Group II: Sodium Bicarbonate Active Control 1 Intervention

Participants randomized to the alkali therapy will receive oral sodium bicarbonate 500mg tablets three times a day, reflecting a common starting dose at clinical practice. Thereafter, decisions around dose titration for the sodium bicarbonate will then be transferred to the participant's nephrologist who will be responsible for monitoring the participants serum bicarbonate concentration with a goal of maintaining a serum bicarbonate level \>22 mEq/L. Participants will receive counselling from a registered dietician (RD) as part of the standard care. Intervention will last 12 months.

Who Is Running the Clinical Trial?

Dylan MacKay

Lead Sponsor

Trials

3

Recruited

80+

University of Manitoba

Lead Sponsor

Trials

628

Recruited

209,000+

Charles Semba

University of Manitoba

Chief Medical Officer since 2020

MD from the University of Minnesota Medical School

Rick Pauls

University of Manitoba

Chief Executive Officer since 2010

Bachelor of Arts in Economics from the University of Manitoba, MBA in Finance from the University of North Dakota

Dalhousie University

Collaborator

Trials

177

Recruited

402,000+

Dr. David Berd

Dalhousie University

Chief Medical Officer since 2020

MD

Dr. Kim Brooks

Dalhousie University

Chief Executive Officer since 2023

PhD in Tax Law

Mount Saint Vincent University

Collaborator

Trials

23

Recruited

2,300+

Findings from Research

In a study of 108 CKD patients over 5 years, both base-producing fruits and vegetables (F + V) and oral sodium bicarbonate (NaHCO3) effectively improved metabolic acidosis and preserved kidney function, with no significant difference in eGFR decline between the two treatments.

However, the F + V group showed better improvements in cardiovascular disease risk indicators, including lower blood pressure and lower levels of harmful lipoproteins, suggesting that F + V may be a superior option for reducing cardiovascular risks in CKD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fruit and Vegetable Treatment of Chronic Kidney Disease-Related Metabolic Acidosis Reduces Cardiovascular Risk Better than Sodium Bicarbonate. Goraya, N., Munoz-Maldonado, Y., Simoni, J., et al.[2020]

In a study of 108 participants with chronic kidney disease, both fruit and vegetable (F + V) interventions and oral sodium bicarbonate (NaHCO3) effectively improved metabolic acidosis over 5 years, with no significant difference in plasma total CO2 levels between the two treatments.

The F + V group had significantly better overall health scores and experienced no cardiovascular disease events, compared to 6 events in the usual care group and 2 in the NaHCO3 group, suggesting that F + V not only addresses metabolic acidosis but also offers additional health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of Chronic Kidney Disease-Related Metabolic Acidosis With Fruits and Vegetables Compared to NaHCO3 Yields More and Better Overall Health Outcomes and at Comparable Five-Year Cost. Goraya, N., Munoz-Maldonado, Y., Simoni, J., et al.[2021]

This trial will assess the feasibility of using base-producing fruits and vegetables as an alternative dietary treatment for metabolic acidosis in individuals with chronic kidney disease (CKD), compared to the standard treatment of oral sodium bicarbonate.

A total of 40 adult participants with CKD and metabolic acidosis will be randomized to either the fruit and vegetable group or the sodium bicarbonate group, with the goal of generating data to inform a larger future trial aimed at slowing CKD progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing Dietary Acid With Fruit and Vegetables Versus Oral Alkali in People With Chronic Kidney Disease (ReDACKD): A Clinical Research Protocol. Mollard, R., Cachero, K., Luhovyy, B., et al.[2023]

A very low-protein diet (VLPD) significantly reduces acid load in chronic kidney disease (CKD) patients, leading to improved blood pressure and metabolic markers over 6 and 12 months.

The study suggests that nutritional therapy, particularly VLPD, should be integrated into CKD management to effectively address metabolic acidosis, which is crucial for slowing disease progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Very Low-Protein Diet (VLPD) Reduces Metabolic Acidosis in Subjects with Chronic Kidney Disease: The "Nutritional Light Signal" of the Renal Acid Load. Di Iorio, BR., Di Micco, L., Marzocco, S., et al.[2018]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Fruit and Vegetable Treatment of Chronic Kidney Disease-Related Metabolic Acidosis Reduces Cardiovascular Risk Better than Sodium Bicarbonate. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Dietary acid reduction with fruits and vegetables or bicarbonate attenuates kidney injury in patients with a moderately reduced glomerular filtration rate due to hypertensive nephropathy. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Dietary Treatment of Metabolic Acidosis in Chronic Kidney Disease. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Treatment of Chronic Kidney Disease-Related Metabolic Acidosis With Fruits and Vegetables Compared to NaHCO3 Yields More and Better Overall Health Outcomes and at Comparable Five-Year Cost. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Reducing Dietary Acid With Fruit and Vegetables Versus Oral Alkali in People With Chronic Kidney Disease (ReDACKD): A Clinical Research Protocol. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Very Low-Protein Diet (VLPD) Reduces Metabolic Acidosis in Subjects with Chronic Kidney Disease: The "Nutritional Light Signal" of the Renal Acid Load. [2018]