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Dietary Study for Chronic Kidney Disease Stage 3

This study is looking at how different protein sources affect people with Stage 3 chronic kidney disease (CKD). Researchers want to see if replacing some protein in a vegetarian diet with red meat changes levels of a substance called trimethylamine N-oxide (a "uremic toxin" that can build up in kidney disease). You might be able to join if you are 40-70 years old, male or postmenopausal female, and have Stage 3 CKD (meaning your eGFR, a measure of kidney function, is between 30-59ml/min/1.73m^2). If your eGFR is higher, you would also need to have a certain level of albumin (a protein) in your urine. The study plans to enroll up to 15 participants. The current status of the study is unclear.

Study design
This is a single-blind crossover study, meaning you and the researchers won't know which diet you're on at certain times. It will compare a lacto-ovo vegetarian diet to the same diet with 20% of the protein from red meat, involving up to 15 participants.
What's involved
You will have a 2-week period eating your usual diet, then two 3-week periods on specific controlled diets, separated by a 5-week period eating your usual diet. Blood samples will be collected at various times throughout the study.
Compensation
Not stated in the trial record.
Follow-up
Your trimethylamine N-oxide levels will be measured over 13 weeks, with collections before and during the last two weeks of each 3-week diet period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07105670

Effects of Replacing High Protein Foods in People With Chronic Kidney Disease

Recruiting
NAAges 40–70InterventionalTreatment
Indiana University
~15 participants
Updated 2026-08-11 on ClinicalTrials.gov
What's tested:Controlled dietary intervention

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Serum trimethylamine N-oxide
Measured over 13 Weeks (collections in week 1, 2, 4, 5, 9, 10, 12, 13 which corresponds to before and during the last two weeks of each of the three-week controlled diet periods).

Conditions

Chronic Kidney Disease Stage 3

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NCT07105670

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Purdue University

    West Lafayette, Indianastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Brandon Kistler
[email protected]
765-494-5406
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Serum trimethylamine N-oxide13 Weeks (collections in week 1, 2, 4, 5, 9, 10, 12, 13 which corresponds to before and during the last two weeks of each of the three-week controlled diet periods).

    Intra- and interparticipant variability of serum concentrations as measured by high performance liquid chromatography-mass spectrometry