Effects of Replacing High Protein Foods in People With Chronic Kidney Disease (NCT07105670) | Clinical Trial Compass
RecruitingNot Applicable
Effects of Replacing High Protein Foods in People With Chronic Kidney Disease
United States15 participantsStarted 2026-07-01
Plain-language summary
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.
Who can participate
Age range
40 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 40-70 years
* Male or postmenopausal female
* Stage 3 CKD (eGFR between 30-59ml/min/1.73m\^2 by the CKD-EPI equation (without race correction)).
* If eGFR is greater than or equal to 45ml/min/1.73m\^2 then albuminuria must be greater than 300mg/g creatinine by spot urine.
* Willing to consume controlled diet for duration of the study
* Willing to collect fecal samples at home
Exclusion Criteria:
* Hemoglobin A1c greater than 7% within previous six months
* Treatment with metformin or insulin within previous three months
* Blood pressure greater than 150/100 mmHg from chart of home on at least two occasions in prior month (can be inclusive of screening visit)
* Change in cardiovascular and/or hypertension medication in the last 30 days
* History of major gastrointestinal disease (e.g. inflammatory bowel disease, uncontrolled irritable bowel syndrome, C. difficile chronic infection, celiac disease, diverticulitis, stomach or duodenal ulcers)
* Known HIV disease
* Hospitalization in the last two months
* Significant recent unintentional weight loss (5% of weight over past three months)
* Cancer or received cancer treatment in the last year (except basal cell carcinoma)
* Prior bariatric surgery (i.e. gastric bypass, sleeve gastrectomy) or restrictive bariatric surgery (i.e. adjustable gastric band)
* Treatment with immunosuppressive medications in the past six months or more than one week of treatment with prednisone greater than 10mg per day in the …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Serum trimethylamine N-oxide
Timeframe: 13 Weeks (collections in week 1, 2, 4, 5, 9, 10, 12, 13 which corresponds to before and during the last two weeks of each of the three-week controlled diet periods).