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

Part of paid clinical trials in West Lafayette, Indiana.

Sponsor
Indiana University
Study ID
NCT07105670
Status
Recruiting
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Conditions

  • Chronic Kidney Disease Stage 3

Eligibility Criteria

Sex
ALL
Age
40 Years - 70 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jul 1, 2026
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Purdue UniversityWest LafayetteIndiana47906
Brandon Kistler
[email protected]
7654945406

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By research site
Purdue University· West Lafayette, IN

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