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| ID | Type | Description | Link |
|---|---|---|---|
| RSG-23-1154989-01-CSCT | Other Grant/Funding Number | American Cancer Society |
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| Name | Class |
|---|---|
| American Cancer Society, Inc. | OTHER |
| Indiana University | OTHER |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High cysteine diet | Experimental | Participants will eat a diet higher in cysteine, relying on more animal based protein. |
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| Low cysteine diet | Experimental | Participants will eat a diet lower in cysteine, relying on more plant based protein. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Cysteine Diet | Other | A diet low in cysteine, about 1.4 g/1000 kcal. |
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| Measure | Description | Time Frame |
|---|---|---|
| Colonic inflammation | Fecal calprotectin, a marker of intestinal inflammation, will be measured from 100 mg of stool collected at the respective timeframe using a CALPRO Calprotectin ELISA test. | 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) |
| Fecal microbial content | Microbial genomic DNA will be extracted from stool obtained at the respective timeframe using a Qiagen DNeasy PowerSoil Kit. Genomic DNA will be fragmented using a Covaris S2 and processed into libraries using an Integrated DNA Technologies xGen DNA Library Prep Kit. Final libraries will be pooled and sequenced on an Illumina NovaSeq X using 25B chemistry. | 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) |
| Systemic markers of inflammation | Serum from blood collected at the respective timeframe will be analyzed in triplicate with the Bio-Plex® Precision Pro™ (Bio rad, Hercules, CA) human cytokine 10-plex immunoassay to detect IL-1β, IL-6, IFN-γ, TNF-α, IL-2, IL-4, IL-5, IL-10, IL-12 (p70) and IL-13. | Baseline, Week 1 (Day 9), Week 2 (Day 16), Week 3 (Day 23), Week 4 (Day 30), Week 7 (Day 50), Week 8 (Day 58), Week 9 (Day 65), Week 11 (Day 79) |
| Measure | Description | Time Frame |
|---|---|---|
| Quantification of serum hydroxycortisol and cysteine metabolism markers | Serum hydroxycortisol and measures of cysteine metabolism (cysteine, homocysteine, lanthionine, cystathionine, serine) will be determined using hydrophilic interaction liquid chromatography with triple quadrupole tandem mass spectrometry by the Purdue Metabolite Profiling Facility. | Baseline, Week 1 (Day 9), Week 2 (Day 16), Week 3 (Day 23), Week 4 (Day 30), Week 7 (Day 50), Week 8 (Day 58), Week 9 (Day 65), Week 11 (Day 79) |
| Measure | Description | Time Frame |
|---|---|---|
| Psychosocial health | survey | Baseline, Week 4 (Day 30), Week 8 (Day 58),Week 11 (Day 79) |
| Medication use | survey | Baseline, Week 4 (Day 30), Week 8 (Day 58),Week 11 (Day 79) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patricia G Wolf, PhD, RD | Contact | 765-494-1860 | wolfpm@purdue.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Clinical Research Center | Not yet recruiting | Indianapolis | Indiana | 46202 | United States |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D009369 | Neoplasms |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
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Randomized controlled cross-over feeding trial
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| High Cysteine Diet |
| Other |
A diet high in cysteine, about 3 g/1000 kcal. |
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| Absolute and relative quantification of microbial cysteine metabolic genes | Microbial genomic DNA will be extracted from stool obtained at the respective timeframe using a Qiagen DNeasy PowerSoil Kit. To estimate gene content, metagenomic libraries will be constructed from stool DNA. Metagenomic data will be processed to filter potential host DNA sequences and remove low-quality reads. Raw shotgun data will be assembled using MEGAHIT and assembled contigs will be binned using MetaBAT2. Taxonomic classification of binned contigs will be performed using CAT/BAT and differences genera that have functional genes for sulfur metabolism will be assessed. Assembled and binned metagenomes will be surveyed for genes for cysteine metabolism using custom hidden Markov model (HMM) libraries. | 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) |
| Exfoliated intestinal epithelial cell transcriptomics | Exfoliated intestinal epithelial cells separated from stool collected at the respective timeframe with gene expression analysis | Baseline, Week 1 (Day 8), Week 4 (Day 29), Week 8 (Day 57), Week 11 (Day 78) |
| Bowel habits | survey | Baseline, Week 4 (Day 30), Week 8 (Day 58),Week 11 (Day 79) |
| Purdue Clinical Research Center | Recruiting | West Lafayette | Indiana | 47906 | United States |
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| D005767 | Gastrointestinal Diseases |
| D012002 | Rectal Diseases |