40 Participants Needed

Diet Modification for Chronic Kidney Disease

(ReDACKD Trial)

Recruiting at 2 trial locations
RM
KC
SM
Overseen BySepideh Mahboobi, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.12367

Who Is on the Research Team?

NT

Navdeep Tangri, MD, PhD

Principal Investigator

Seven Oaks General Hospital Chronic Disease Innovation Centre

DM

Dylan MacKay, PhD

Principal Investigator

George and Fay Yee Centre for Healthcare Innovation

KT

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%.
See 5 more

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.
See 5 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Alkalizing Fruit and VegetablesExperimental Treatment1 Intervention
Group II: Sodium BicarbonateActive Control1 Intervention

Find a Clinic Near You

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

Citations

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 ...
Alkaline Diets and Kidney DiseaseThere is accumulating evidence that fruits and vegetables as dietary alkali do indeed help in kidney disease.
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.
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 ...
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).
Dietary Acid Load and Chronic Kidney DiseaseHigh citrate and malate in fruits and vegetables induce an alkalinizing effect syndrome with decreased hydrogen ions. Furthermore, plant proteins usually ...
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 ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security