Replacing part of dietary protein with red meat in people with stage 3 chronic kidney disease
The Effects of Replacing Red Meat With Alternative Protein Sources on Gut-Derived Metabolites in People With Chronic Kidney Disease
NA · Indiana University · NCT07105670
This study will test whether swapping some dietary protein for red meat changes levels of uremic toxins like TMAO in adults with stage 3 chronic kidney disease.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 40 Years to 70 Years |
| Sex | All |
| Sponsor | Indiana University (other) |
| Drugs / interventions | prednisone |
| Locations | 1 site (West Lafayette, Indiana) |
| Trial ID | NCT07105670 on ClinicalTrials.gov |
What this trial studies
This single-blind, randomized crossover feeding study will compare three weeks on a lacto-ovo vegetarian diet with three weeks of the same diet in which 20% of the protein is replaced by red meat, following a two-week baseline and a five-week washout. Up to 15 adults with stage 3 CKD will be randomized to diet order and provided controlled meals. The study will measure serum and fractional urinary excretion of uremic toxins, including trimethylamine N-oxide (TMAO), and collect fecal samples. Data analysis will use linear mixed-effect models to account for repeated measures and descriptive statistics to summarize participant characteristics.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40–70 with stage 3 CKD (eGFR 30–59 ml/min/1.73 m2, or eGFR ≥45 with albuminuria >300 mg/g), male or postmenopausal female, who are willing to eat controlled meals and collect stool samples.
Not a fit: Patients with poorly controlled diabetes, recent use of insulin or metformin, uncontrolled hypertension, major gastrointestinal disease, or known HIV are excluded and are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could identify a simple dietary change that lowers uremic toxin levels and may reduce complications associated with stage 3 CKD.
How similar studies have performed: Observational and small feeding studies have shown red meat can raise TMAO levels, but controlled crossover feeding specifically in stage 3 CKD is limited, making this pilot relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
West Lafayette, Indiana
- Purdue University — West Lafayette, Indiana, United States (RECRUITING)
Study contacts
- Study coordinator: Brandon Kistler
- Email: bmkistle@purdue.edu
- Phone: 765-494-5406
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Kidney Disease Stage 3