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NCT03582306 · ClinicalTrials.gov registry record · NA
Exploring the Effects of a High Chlorophyll Dietary Intervention to Reduce Colon Cancer Risk in Adults
A NA study, sponsored by Auburn University.
- Completed
- Registry status
- NA
- Development phase
- 50
- Enrollment target
NCT03582306 is a NA study that has completed, run by Auburn University. The registered enrollment target is 50 participants.
The verdict
NCT03582306, a NA study, has completed, sponsored by Auburn University.
- COMPLETED
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
Study Summary
Colon cancer is the third most common cancer in men and women and over 70% of cases are preventable. A western diet, characterized by low vegetable and high red and processed meat intake, indisputably increases colon cancer risk. Heme, which gives red meat its color, is highly reactive, induces hyperproliferation and promotes DNA damage in the colon to a greater degree than any other red meat-associated carcinogen. Preclinical models indicate dietary chlorophyll, which gives green leafy vegetables their color, binds and stabilizes heme in the lumen, preventing genotoxicity. Additionally, data from our randomized controlled weight loss trial indicate increasing red meat consumption has deleterious effects on the gut microbiome, which is also implicated in colon cancer etiology. Because heme-containing foods are the richest sources of bioavailable iron and several other vitamins and minerals, mitigating their potential risks may be more beneficial than eliminating meat, poultry, fish and seafood in their entirety from the diet for risk reduction. This feasibility study will begin to explore the research question: Will adding chlorophyll-rich green leafy vegetables to the diet prevent the deleterious effects of heme-rich red meat on the human host and microbiome? The investigators will randomly assign 50 adults at increased risk of colorectal adenoma to a block randomized crossover study with two 4-week dietary regimens in which: 1) participants will be provided with frozen green leafy vegetables and counseled to consume a high chlorophyll diet including 1 cup per day of cooked green leafy vegetables and normal meat (high heme) consumption; or 2) continue their normal high heme, low chlorophyll diet (control). A 4-week washout period encouraging habitual diet will be employed between the intervention periods and data will be collected at all four time points. This study is critical in translating preclinical findings and has the potential to open the door to new know
Interventions
- BEHAVIORAL High chlorophyll diet - intervention 1st
- BEHAVIORAL High chlorophyll diet - control 1st
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2018-07-23 |
| Est. Completion | 2018-12-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03582306
The ClinicalTrials.gov registry entry for NCT03582306 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Auburn University, which has 54 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which High chlorophyll diet - intervention 1st is the first listed.
NCT03582306 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03582306 about?
NCT03582306 is a clinical study titled "Exploring the Effects of a High Chlorophyll Dietary Intervention to Reduce Colon Cancer Risk in Adults". Colon cancer is the third most common cancer in men and women and over 70% of cases are preventable. A western diet, characterized by low vegetable and high red and processed meat intake, indisputably increases colon cancer risk. Heme, which gives red meat its color, is highly reactive, induces hype...
What is the current status of trial NCT03582306?
This trial is currently completed. It is a NA study. The enrollment target is 50 participants. The study started on 2018-07-23. Estimated completion is 2018-12-12.
What interventions are being tested in trial NCT03582306?
The interventions under investigation include: High chlorophyll diet - intervention 1st (BEHAVIORAL), High chlorophyll diet - control 1st (BEHAVIORAL).
Who is sponsoring clinical trial NCT03582306?
This trial is sponsored by Auburn University, which has 54 total clinical trials registered on ClinicalTrials.gov.
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