Chronic Kidney Disease Stage 3NCT07105670
Effects of Replacing High Protein Foods in People With Chronic Kidney Disease
A study of Chronic Kidney Disease Stage 3, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Chronic Kidney Disease Stage 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Purdue University
West Lafayette, Indiana, 47906
Brandon Kistler, 765-494-5406, bmkistle@purdue.edu
About this study
Official title: The Effects of Replacing Red Meat With Alternative Protein Sources on Gut-Derived Metabolites in People With Chronic Kidney Disease
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.
Read the 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
- Being tested
- Controlled dietary intervention
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controlled dietary interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Controlled dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum trimethylamine N-oxide
Intra- and interparticipant variability of serum concentrations as measured by high performance liquid chromatography-mass spectrometry
Measured: 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
Including p-cresyl sulfate and indoxyl sulfate measured by high performance liquid chromatography-mass spectrometry
Measured: 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
Measured by a ratio of serum and urine values
Measured: 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
Diversity and composition of the gut microbiome
Measured: 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
Measured at the end of each study period by the Gastrointestinal Symptom Rating Scale. This is a 15-item questionnaire that includes five domains. Each item is scored from 1 to 7 and the mean score in each domain is presented.
Measured: 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
Measured on a scale from 1 to 7 using the Bristol Stool Scale/Chart.
Measured: 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).
Blood pressure
Measured: 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).
Arterial Stiffness
Carotid-femoral pulse wave velocity
Measured: 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).
Height
Measured: 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).
Weight
Measured: 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).
Handgrip Strength
Measured: 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).
Total cholesterol
Measured: 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).
High density lipoprotein
Measured: 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).
Low Density Lipoprotein
Measured: 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).
Triglycerides
Measured: 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).
Apolipoprotein B
Measured: 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).
Blood glucose
Fasting blood glucose
Measured: 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).
Serum calcium
Measured: 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).
Serum Potassium
Measured: 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).
Serum bicarbonate
Measured: 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).
Subjective global assessment
Scored on a scale from 1-7 (severely malnourished to well nourished)
Measured: 13 Weeks (collections in week 2, 5, 10, 13 which corresponds to before and during the last week of each of the three-week controlled diet periods).
Albumin to creatinine ratio
Measured: 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).
Blood urea nitrogen
Measured: 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).
Creatinine
Measured: 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).
Serum Phosphate
Measured: 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 phosphorus excretion
From 24-hour urine collection
Measured: 13 Weeks (collections in week 2, 5, 10, 13 which corresponds to before and after each of the three-week controlled diet periods).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start1 Sep 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease Stage 3Studies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sharon Moe, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07105670
- Sponsor's protocol ID
- 25168
- Status last verified
- Aug 2026
- First submitted
- 30 Jul 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Replacing Red Meat With Alternative Protein Sources on Gut-Derived Metabolites in People With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT07105670
- Acronym / sponsor ID
- 25168
- Conditions
- Chronic Kidney Disease Stage 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 6 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lacto-ovo vegetarian diet alone; then lacto-ovo vegetarian with red meat diet | Experimental | Other: Controlled dietary interventionParticipants 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. |
| Lacto-ovo vegetarian with red meat diet; then lacto-ovo vegetarian diet alone | Experimental | Other: Controlled dietary interventionParticipants 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Controlled dietary interventionParticipants 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. | Other | 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 |
Primary outcome
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).
Intra- and interparticipant variability of serum concentrations as measured by high performance liquid chromatography-mass spectrometry
25 secondary outcomes
Additional serum uremic toxins
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).
Urinary excretion of uremic toxins
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).
Gut microbiota
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).
Gastrointestinal symptoms
Time frame: 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
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).
Blood pressure
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).
Arterial Stiffness
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).
Height
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).
Weight
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).
Handgrip Strength
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).
Total cholesterol
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).
High density lipoprotein
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).
Low Density Lipoprotein
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).
Triglycerides
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).
Apolipoprotein B
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).
Blood glucose
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).
Serum calcium
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).
Serum Potassium
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).
Serum bicarbonate
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).
Subjective global assessment
Time frame: 13 Weeks (collections in week 2, 5, 10, 13 which corresponds to before and during the last week of each of the three-week controlled diet periods).
Albumin to creatinine ratio
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).
Blood urea nitrogen
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).
Creatinine
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).
Serum Phosphate
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).
Urinary phosphorus excretion
Time frame: 13 Weeks (collections in week 2, 5, 10, 13 which corresponds to before and after each of the three-week controlled diet periods).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Chronic Kidney Disease Stage 3, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brandon Kistler (765-494-5406, bmkistle@purdue.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.