NCT07105670Recruiting
Effects of Replacing High Protein Foods in People With Chronic Kidney Disease
The Effects of Replacing Red Meat With Alternative Protein Sources on Gut-Derived Metabolites in People With Chronic Kidney Disease
Source: ClinicalTrials.gov · Last updated 11 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 30 Jul 2025
- Start date
- 1 Sept 2026
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Indiana University
- Diseases
- Chronic kidney disease
- NCT number
- NCT07105670
What you commit to
- Study type: Interventional
- Planned participants: 15
- From 1 Sept 2026 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- 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 past three months (or equivalent steroid dose of non-prednisone steroids)
Other illness
- 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
- Known food allergy that would influence the ability to consume the study diets
- History of hyperkalemia defined as greater than 5.5mmol/L on at least two occasions
- Other medical conditions or concerns at the discretion of the investigators
Lab values
- Hemoglobin A1c greater than 7% within previous six months
Other
- Hospitalization in the last two months
- Significant recent unintentional weight loss (5% of weight over past three months)
- Recent antibiotic use defined as a single course of antibiotics within the past three months or two or more courses within the past six months
Who the study is looking for
- 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
Age in the registry: 40 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Purdue University Coordinator of this site? Confirm its status | West Lafayette | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.