RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: Controlled dietary intervention for Chronic Kidney Disease Stage 3

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.

Official registry: https://clinicaltrials.gov/study/NCT07105670 · Indiana University · enrollment listed as 15

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Controlled dietary intervention. The registry lists allocation as randomized. 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.

They plan to enroll about 15 people at West Lafayette. Taking part typically means study visits and measurements plus check-ins.

Official title (unrewritten)

The Effects of Replacing Red Meat With Alternative Protein Sources on Gut-Derived Metabolites in People With Chronic Kidney Disease

Interventions: Controlled dietary intervention

Primary outcome (registry wording): Serum trimethylamine N-oxide

Who it is for (from inclusion criteria)

Ages 40 Years to 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

Who the registry excludes

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)
Hospitalization in the last two months
Significant recent unintentional weight loss (5% of weight over past three months)

Public study contact (from the registry)

Brandon Kistler

765-494-5406

bmkistle@purdue.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

Purdue University — West Lafayette, Indiana (recruiting)

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FAQ about this NCT record

Is NCT07105670 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07105670?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07105670?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary