Diet Modification for Chronic Kidney Disease

(ReDACKD Trial)

Recruiting at 2 trial locations

Overseen By Sepideh Mahboobi, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dylan MacKay

Must not be taking: Potassium binders

Disqualifiers: Dialysis, COPD, Heart failure, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a diet rich in alkalizing fruits and vegetables can help manage metabolic acidosis, a condition where acid accumulates in the body due to worsening chronic kidney disease. Researchers seek to evaluate whether this diet can serve as a better alternative to the usual treatment, sodium bicarbonate, which often causes side effects. Participants will either receive home-delivered fruits and vegetables or take sodium bicarbonate tablets. Individuals with chronic kidney disease and specific blood test results, who are part of the nephrology clinics in Winnipeg or Halifax, might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to innovative dietary approaches for managing chronic kidney disease.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that eating fruits and vegetables effectively helps people with chronic kidney disease manage metabolic acidosis, a condition where acid levels in the body are too high. This dietary approach benefits kidney health, and most people can follow it without major issues.

Research has shown that sodium bicarbonate can also slow kidney damage and improve kidney health over time. However, some people might experience side effects like bloating or gas. It is generally safe when monitored by a healthcare provider.

Both treatments aim to control acid levels in the body but work differently. Fruits and vegetables offer a natural way to balance acids, while sodium bicarbonate provides a direct chemical method. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for chronic kidney disease because they introduce innovative approaches to managing the condition. Unlike traditional treatments that often rely on medication alone, one arm of this trial uses alkalizing fruits and vegetables to naturally adjust the body's pH balance, which could reduce kidney stress without pharmaceutical intervention. Additionally, the sodium bicarbonate arm provides a non-invasive, oral option to maintain optimal bicarbonate levels, potentially improving kidney function by addressing acidosis more directly than typical dietary adjustments. These approaches offer promising alternatives to standard medication regimens, potentially enhancing patient outcomes with fewer side effects.

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

This trial will compare two approaches for managing metabolic acidosis in chronic kidney disease. Participants in one arm will receive alkalizing fruits and vegetables, which research has shown can slow the disease's progression by neutralizing acid in the body. In another arm, participants will receive sodium bicarbonate, a common treatment shown to slow kidney damage and improve kidney health by raising bicarbonate levels in the blood to balance acids. Both approaches offer promising ways to manage metabolic acidosis, a common issue in kidney disease. ^{1 2 3 6 7}

Who Is on the 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

Are You a Good Fit for This Trial?

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

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

Your hemoglobin A1c level is higher than 11%.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Alkalizing Fruit and Vegetables
• Sodium bicarbonate

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.

How Is the Trial Designed?

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+

Dalhousie University

Collaborator

Trials

177

Recruited

402,000+

Mount Saint Vincent University

Collaborator

Trials

23

Recruited

2,300+

Published Research Related to This Trial

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]

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]

Chronic kidney disease can lead to chronic metabolic acidosis, but correcting this condition through dietary changes can slow the progression of kidney disease.

To prevent metabolic acidosis, patients should increase their intake of fruits and vegetables while reducing animal protein to 0.8-1.0 g per kg body weight, starting early even in those with moderate kidney impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

In patients with stage 2 hypertensive nephropathy, both oral sodium bicarbonate and a diet rich in fruits and vegetables effectively reduced markers of kidney injury, such as urinary albumin and transforming growth factor β.

The study suggests that reducing dietary acid can protect kidney function in patients with moderately reduced glomerular filtration rate (GFR), making fruits and vegetables a viable alternative to sodium bicarbonate for kidney health.

NCBI (Pubmed)

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. Goraya, N., Simoni, J., Jo, C., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10408321/

Reducing Dietary Acid With Fruit and Vegetables Versus Oral ... The objective of this study is to evaluate the feasibility of base-producing F+V consumption for metabolic acidosis treatment in people with CKD ...

2. nutrition.org nutrition.org/alkaline-diets-and-kidney-disease/

Alkaline Diets and Kidney Disease There is accumulating evidence that fruits and vegetables as dietary alkali do indeed help in kidney disease.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7792697/

Alkali supplementation as a therapeutic in chronic kidney ... Several small clinical trials have demonstrated that supplementation with NaHCO3 or other alkalizing agents slows renal functional decline in patients with CKD.

4. amjmed.com amjmed.com/article/S0002-9343(24)00357-7/fulltext

Kidney and Cardiovascular Protection Using Dietary Acid ... Results. Chronic kidney disease progression was slower in participants receiving fruits and vegetables or oral NaHCO3 than Usual Care [mean ...

5. academic.oup.com academic.oup.com/ndt/article/40/4/751/7758247

Effects of dietary interventions for metabolic acidosis in ... Existing data suggest that dietary interventions can be beneficial in the management of chronic kidney disease (CKD).

6. journals.lww.com journals.lww.com/sjkd/fulltext/2021/32060/dietary_acid_load_and_chronic_kidney_disease.1.aspx

Dietary Acid Load and Chronic Kidney Disease High citrate and malate in fruits and vegetables induce an alkalinizing effect syndrome with decreased hydrogen ions. Furthermore, plant proteins usually ...

7. trialx.com trialx.com/clinical-trials/listings/244883/reducing-dietary-acid-with-food-versus-oral-alkali-in-people-with-chronic-kidney-disease-redackd/

Reducing Dietary Acid With Food Versus Oral Alkali in ... Fruit and vegetables are an effective and well-tolerated therapy for the treatment of metabolic acidosis in CKD. While oral alkali therapy has ...