Actively Recruiting
Effects of Replacing High Protein Foods in People With Chronic Kidney Disease
Led by Indiana University · Updated on 2026-05-01
15
Participants Needed
1
Research Sites
59 weeks
Total Duration
On this page
Sponsors
I
Indiana University
Lead Sponsor
N
National Center for Advancing Translational Sciences (NCATS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this crossover clinical trial is to explore the effects of red meat intake on serum and fractional urinary excretion of uremic toxins including trimethylamine N-oxide in people with chronic kidney disease.
CONDITIONS
Official Title
Effects of Replacing High Protein Foods in People With Chronic Kidney Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 40-70 years
- Male or postmenopausal female
- Stage 3 chronic kidney disease with eGFR between 30-59 ml/min/1.73m2 by CKD-EPI equation (without race correction)
- If eGFR is 45 ml/min/1.73m2 or higher, albuminuria must be greater than 300 mg/g creatinine by spot urine
- Willing to consume controlled diet for the duration of the study
- Willing to collect fecal samples at home
You will not qualify if you...
- Hemoglobin A1c greater than 7% within the previous six months
- Treatment with metformin or insulin within the previous three months
- Blood pressure greater than 150/100 mmHg on at least two occasions in the prior month
- Change in cardiovascular or hypertension medication in the last 30 days
- History of major gastrointestinal disease such as inflammatory bowel disease, uncontrolled irritable bowel syndrome, chronic C. difficile infection, celiac disease, diverticulitis, or stomach/duodenal ulcers
- Known HIV disease
- Hospitalization in the last two months
- Significant unintentional weight loss (5% over past three months)
- Cancer or cancer treatment in the last year (except basal cell carcinoma)
- Prior bariatric surgery (gastric bypass, sleeve gastrectomy) or restrictive bariatric surgery (adjustable gastric band)
- Treatment with immunosuppressive medications in the past six months or prednisone over 10 mg/day for more than one week in the past three months
- Recent antibiotic use (single course within past three months or two or more courses within past six months)
- Known food allergy affecting ability to consume study diets
- History of hyperkalemia (greater than 5.5 mmol/L on at least two occasions)
- Other medical conditions or concerns as decided by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Purdue University
West Lafayette, Indiana, United States, 47906
Actively Recruiting
Research Team
B
Brandon Kistler
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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