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

NCT ID: NCT07105670

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2026-06-30

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.

Detailed Description

This study will be a single-blind crossover, human-feeding study comparing 3 weeks of a lacto-ovo vegetarian diet to the same diet with 20% of the protein replaced by red meat. There will be a 2-week baseline period and a 5-week washout period where participants will consume their typical, self-selected diet. Once eligible, the participant will be randomized to a diet order. The investigators will recruit up to 15 participants. Descriptive statistics (means and standard deviations) will be used to summarize the characteristics of the study population. In general, data will be analyzed using linear mixed-effect models to account for the potential correlation among measurements from the same participant. A power analysis of this pilot study will be conducted based on the estimated interparticipant and intraparticipant variabilities to estimate the required number of participants to detect a certain size of difference with a certain power for a full study.

Conditions

Chronic Kidney Disease Stage 3

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Lacto-ovo vegetarian diet

A lacto-ovo vegetarian diet providing 0.8 g/kg/day of protein.

Group Type: ACTIVE_COMPARATOR

Controlled dietary intervention

Intervention Type: 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.

Red meat diet

The lacto-ovo vegetarian diet with 20% of the protein replaced by red meat.

Group Type: EXPERIMENTAL

Controlled dietary intervention

Intervention Type: 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.

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Sharon Moe

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Purdue University

West Lafayette, Indiana, United States

Countries

United States

Central Contacts

Brandon Kistler

Role: CONTACT

bmkistle@purdue.edu

765-494-5406

Facility Contacts

Brandon Kistler

Role: primary

bmkistle@purdue.edu

7654945406

Other Identifiers

K12TR004415

Identifier Type: NIH

Identifier Source: secondary_id

View Link

25168

Identifier Type: -

Identifier Source: org_study_id