RecruitingNot ApplicableNCT07105670

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

Sponsor

Indiana University

Enrollment

15 participants

Start Date

May 11, 2026

Study Type

INTERVENTIONAL

Conditions

Chronic Kidney Disease Stage 3

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

Min Age: 40 YearsMax Age: 70 Years

Inclusion Criteria6

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 Criteria15

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

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Interventions

OTHERControlled dietary intervention

Participants will complete a 2-week baseline period consuming their standard diet without any food or beverages provided followed by a randomized, crossover-controlled feeding study of a lacto-ovo vegetarian diet versus the same diet with 20% of the protein replaced by red meat. In between the two diets, there will be a five-week washout where participants will consume their standard diet without any food or beverages provided.