NCT07105670 Effects of Replacing High Protein Foods in People With Chronic Kidney Disease
| NCT ID | NCT07105670 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Indiana University |
| Condition | Chronic Kidney Disease Stage 3 |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2026-09-01 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 15 participants in total. It began in 2026-09-01 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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 past three months (or equivalent steroid dose of non-prednisone steroids) * 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 * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07105670 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 70 Years, studying Chronic Kidney Disease Stage 3. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07105670 currently recruiting?
Yes, NCT07105670 is actively recruiting participants. Contact the research team at bmkistle@purdue.edu for enrollment information.
Where is the NCT07105670 trial being conducted?
This trial is being conducted at West Lafayette, United States.
Who is sponsoring the NCT07105670 clinical trial?
NCT07105670 is sponsored by Indiana University. The trial plans to enroll 15 participants.
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