Effects of Replacing High Protein Foods in People With Chronic Kidney Disease
ConditionChronic Kidney Disease Stage 3
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-70
SponsorIndiana University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 40-70 years
Male or postmenopausal female
Stage 3 CKD (eGFR between 30-59ml/min/1.73m² by the CKD-EPI equation (without race correction)).
If eGFR is greater than or equal to 45ml/min/1.73m² then albuminuria must be greater than 300mg/g creatinine by spot urine.
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Controlled dietary intervention
Other 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.
Treatment groups
15 Participants
are divided into 2 treatment groupsGroup A: Lacto-ovo vegetarian diet alone; then lacto-ovo vegetarian with red meat dietExperimental treatment 1 intervention
Group B: Lacto-ovo vegetarian with red meat diet; then lacto-ovo vegetarian diet aloneExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Serum trimethylamine N-oxide
Intra- and interparticipant variability of serum concentrations as measured by high performance liquid chromatography-mass spectrometry
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).Secondary outcomes
1
Additional serum uremic toxins
Including p-cresyl sulfate and indoxyl sulfate measured by high performance liquid chromatography-mass spectrometry
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).2
Urinary excretion of uremic toxins
Measured by a ratio of serum and urine values
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).3
Gut microbiota
Diversity and composition of the gut microbiome
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).4
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.
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).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov