Recruiting

Red Meat

Sponsor:

Indiana University

Code:

NCT07105670

Conditions

Chronic Kidney Disease Stage 3

Eligibility Criteria

Sex: All

Age: 40 - 70

Healthy Volunteers: Not accepted

Interventions

Controlled dietary intervention

Study Details

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.

Conditions

Chronic Kidney Disease Stage 3

Study ID

NCT07105670

Start date

Sep 1, 2026

Status verified date

Aug, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

15 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Lacto-ovo vegetarian diet alone; then lacto-ovo vegetarian with red meat diet

Participants will be assigned to a lacto-ovo vegetarian diet providing 0.8 g/kg/day of protein for the first treatment period; they will then be assigned to continue this diet with 20% of the protein replaced by red meet for the second treatment period.

experimental: Lacto-ovo vegetarian with red meat diet; then lacto-ovo vegetarian diet alone

Participants will be assigned to a lacto-ovo vegetarian diet with 20% of the protein replaced by red meat for the first treatment period; they will then be assigned to a lacto-ovo vegetarian diet alone for the second treatment period.

Interventions

Controlled 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.

Primary outcome measure

  • Serum trimethylamine N-oxide [ Time Frame: 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). ]

Central Contacts and Locations

Central contacts

Brandon Kistler

765-494-5406bmkistle@purdue.edu

Locations

Purdue University

Recruiting

West Lafayette, Indiana, United States, 47906

Contacts

Brandon Kistler

765-494-5406bmkistle@purdue.edu

More Information

Sponsor

Indiana University

Last update posted

Aug 11, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-08-11.