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

NCT07105670 | Recruiting DMC

• 2 other identifiers: 25168K12TR004415
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Serum trimethylamine N-oxide

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

  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).

Secondary Outcomes (25)

• Additional serum uremic toxins

  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).

• Urinary excretion of uremic toxins

  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).

• Gut microbiota

  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).

• Gastrointestinal symptoms

  13 Weeks (collections in week 2, 5, 10, and 13 which corresponds to before and during the last week of each of the three-week controlled diet periods).

• Stool consistency

  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).

Study Arms (2)

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

EXPERIMENTAL

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.

Other: Controlled dietary intervention

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

EXPERIMENTAL

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.

Other: Controlled dietary intervention

Interventions

Controlled dietary intervention OTHER

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.

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

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47906, United States

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Brandon Kistler

CONTACT

765-494-5406; bmkistle@purdue.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 6, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)