The Food Environment, Microbial Cysteine Metabolism, and Cancer Disparities

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Purdue University
Study ID
NCT07086833
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
45 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Low Cysteine Diet — OTHER
    A diet low in cysteine, about 1.4 g/1000 kcal.
  • High Cysteine Diet — OTHER
    A diet high in cysteine, about 3 g/1000 kcal.

Study Details

The goal of this clinical trial is to learn if changing cysteine levels in the diet can influence how the body processes cysteine in Black and White individuals aged 45-75 with a history of non-cancerous polyps. The main questions it aims to answer are: * At the beginning of the study, do Black participants have higher levels of cortisol (a stress hormone) and compounds made from cysteine in their blood when compared to White participants? * Does eating less cysteine lower the body's natural cysteine activity and lead to less gut bacteria that break down cysteine? * Does eating less cysteine lead to less inflammation in the gut and lower levels of markers of inflammation in the blood? Research will compare a high cysteine diet and a low cysteine diet, and each participant will eat both diets. Participants will be in the study for 11 weeks and 2 days. Over the course of the study, participants will: * Eat a high cysteine diet for 3 weeks, and a low cysteine diet for 3 weeks * Eat a moderate cysteine diet for 1 week before each study diet * Complete surveys * Provide blood, stool, and saliva samples * Maintain food logs

Key Dates

Start date
Aug 18, 2025
Status verified
May 2026
Primary completion
Dec 1, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

Arms

  • Experimental: High cysteine diet
    Participants will eat a diet higher in cysteine, relying on more animal based protein.
  • Experimental: Low cysteine diet
    Participants will eat a diet lower in cysteine, relying on more plant based protein.

Primary Outcome Measure

Colonic inflammation [ Time Frame: Baseline, Week 1 (Day 8), Week 2 (Day 15), Week 4 (Day 29), Week 7 (Day 49), Week 8 (Day 57), Week 9 (Day 64), Week 11 (Day 78) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University Hospital Clinical Research CenterIndianapolisIndiana46202
Ariana Moffitt, MPH
[email protected]
765-494-1860
Purdue Clinical Research CenterWest LafayetteIndiana47906
Ariana Moffitt, MPH
[email protected]
765-494-1860

Find similar trials in Indianapolis, IN

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By specialty
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By research site
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