Colon InflammationNCT03548948
Obesity, Iron Regulation and Colorectal Cancer Risk
A study testing High heme iron diet, Low iron diet and Plant-based high non-heme iron diet in people with Colon Inflammation and Iron Malabsorption, run by University of Illinois Chicago at 1 site in United States.
Trial summary
Obesity is an independent risk factor for colorectal cancer (CRC) although the underlying mechanisms have not been elucidated. Dietary nutrients play a key role in both the prevention and promotion of CRC. While iron is an essential nutrient, excess iron is associated with carcinogenesis. Read more about this study
- Who is it for?
- Ages 55 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Colon Inflammation, Iron Malabsorption, Obesity
- What is being tested?
- High heme iron diet, Low iron diet and Plant-based high non-heme iron diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2015to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self-identify as Hispanic, African American, or Caucasian.
- Meet body mass index (BMI > = 30.0 kg/m2) and C-reactive protein (CRP) criteria (> 2.0 mg/dl)
- Post-menopausal (no menstruation in the past 12 months)
- Weight stable (< 3% weight change in the past 3 months)
- Non-smoker
- No major medical problems
- Have a working phone
- No known allergies, intolerance, medical, secular or religious dietary restrictions
Who cannot join
- Chronic constipation (less than three stools per week for several months)
- History or intestinal cancer, inflammatory bowel disease, celiac disease, or malabsorptive bariatric surgery
- Previous intestinal surgery
- H pylori infection or taking H2 blockers (e.g., Zantac, Pepcid) /antacids (e.g., Rolaids) more than 3 times per week
- Significant blood loss or blood donation in past 3 months
- Active gastrointestinal bleed
Show all 17Show fewer
- Any surgery in the past 3 months
- Hemochromatosis
- Sickle cell disease
- Hereditary polyposis
- Rheumatoid arthritis
- Type I or Type II diabetes
- Smoker
- Antibiotic use in the past 2 months
- Excessive alcohol consumption [> 2 standard alcoholic drinks (12 ounces of beer, 5 ounces of wine, 1 shot of hard liquor) per day]
- Aspirin use >81 mg/day OR >325 mg/every other day
- Regularly taking probiotics, fiber supplements, Orlistat (over the counter brand name: Alli), or steroids (inhaled or oral)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60608
About this study
Obesity is an independent risk factor for colorectal cancer (CRC) although the underlying mechanisms have not been elucidated. Dietary nutrients play a key role in both the prevention and promotion of CRC. While iron is an essential nutrient, excess iron is associated with carcinogenesis. Unlike the systemic compartment, the intestinal lumen lacks an efficient system to regulate iron. In conditions when dietary iron malabsorption and intestinal inflammation co-exist, greater luminal iron is associated with increased intestinal inflammation and a shift in the gut microbiota to more pro-inflammatory strains. However, treatments designed to reduce luminal, including diet restriction and chelation, are associated with lower intestinal inflammation and the colonization of protective gut microbes. Obesity is associated with inflammation-induced, hepcidin-mediated, iron metabolism dysfunction characterized by iron deficiency and dietary iron malabsorption. Obesity is also linked to intestinal inflammation. Currently, there is a fundamental gap in understanding how altered iron metabolism impacts CRC risk in obesity.
The investigator's objective is to conduct a crossover controlled feeding trial of: 1) a "Typical American" diet with "high" heme/non-heme iron", 2) a "Typical American" diet with "low" iron, and 3) a Mediterranean diet with "high" non heme iron and examine effects on colonic and systemic inflammation and the gut microbiome.
- Conditions
- Colon Inflammation, Iron Malabsorption, Obesity, Diet Modification
- Being tested
- High heme iron diet, Low iron diet, Plant-based high non-heme iron diet
- Medical subject headings
- Colitis, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High heme iron dietOther
A "Typical American" diet with "high" heme/non-heme iron" (18 mg total). Diet is isocaloric and has a macronutrient composition of total fat 35%, carbohydrates 50%, protein 15% of calories and fiber 9g/1000 calories. Subjects consumes the diet for 3 weeks with a minimum 3 week washout before the next diet.
Low iron dietOther
A "Typical American" diet with "low" heme/non-heme iron" (8 mg total). Diet is isocaloric and has a macronutrient composition of total fat 35%, carbohydrates 50%, protein 15% of calories and fiber 9g/1000 calories. Subjects consumes the diet for 3 weeks with a minimum 3 week washout before the next diet.
Plant-based high non-heme iron dietOther
A plant-based diet with "high" non-heme iron" (18 mg total). Diet is isocaloric and has a macronutrient composition of total fat 35%, carbohydrates 50%, protein 15% of calories and fiber 9g/1000 calories. Subjects consumes the diet for 3 weeks with a minimum 3 week washout before the next diet.
| Study group | Role | What they receive |
|---|---|---|
| High heme iron diet | Other | Not described Receives: Other: High heme iron diet |
| Low iron diet | Other | Not described Receives: Other: Low iron diet |
| Plant-based high non-heme iron diet | Other | Not described Receives: Other: Plant-based high non-heme iron diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in colonic inflammation
Fecal calprotectin, a proxy for colon tissue inflammation, will be measured from stool an calprotectin immunoassay
Measured: Baseline and post-diet (day 22) for each of the three 3-week diets
Secondary outcomes (3)
Change in systemic inflammation
Circulating C-reactive protein, Interleukin-6 (IL-6) and Tumor necrosis factor-alpha (TNF-a) will be measured from serum using immunoassays.
Measured: Baseline and post-diet (day 22) for each of the three 3-week diets
Change in stool microbial community profile at the phylum and genus level
Stool samples to analyze the composition of the microbiota, extracted bacterial genomic DNA will be used as a template for polymerase chain reactions targeting the V4 variable regions of the 16S ribosomal ribonucleic acid gene. Amplicons generated from polymerase chain reaction will be run on the Illumina MiSeq sequencing platform to profile microbial communities at the phylum and genus level.
Measured: Baseline and post-diet (day 22) for each of the three 3-week diets
Change in serum hepcidin
Serum hepcidin will be measured using an immunoassay
Measured: Baseline and post-diet (day 22) for each of the three 3-week diets
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2018
- Study start15 Jul 2015
- Primary completionNov 2018
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon InflammationStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- 1. Typical American Diet with "high" heme/non-heme iron (16 mg) 2. Typical American Diet with "low" iron (8 mg) 3. Plant-based Diet with "high" non-heme iron (16 mg)
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Principal investigator, Lisa Tussing-Humphreys, University of Illinois Chicago
- Investigators
- Lisa Tussing-Humphreys, PhD, MS, RD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03548948
- Sponsor's protocol ID
- 2014-0721
- Status last verified
- Sep 2019
- First submitted
- 7 May 2018
- Last updated
- 27 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity, Iron Regulation and Colorectal Cancer Risk
- ClinicalTrials.gov ID
- NCT03548948
- Acronym / sponsor ID
- 2014-0721
- Conditions
- Colon Inflammation, Iron Malabsorption, Obesity, Diet Modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 15 Jul 2015 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 7 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obesity is an independent risk factor for colorectal cancer (CRC) although the underlying mechanisms have not been elucidated. Dietary nutrients play a key role in both the prevention and promotion of CRC. While iron is an essential nutrient, excess iron is associated with carcinogenesis. Unlike the systemic compartment, the intestinal lumen lacks an efficient system to regulate iron. In conditions when dietary iron malabsorption and intestinal inflammation co-exist, greater luminal iron is associated with increased intestinal inflammation and a shift in the gut microbiota to more pro-inflammatory strains. However, treatments designed to reduce luminal, including diet restriction and chelation, are associated with lower intestinal inflammation and the colonization of protective gut microbes. Obesity is associated with inflammation-induced, hepcidin-mediated, iron metabolism dysfunction characterized by iron deficiency and dietary iron malabsorption. Obesity is also linked to intestinal inflammation. Currently, there is a fundamental gap in understanding how altered iron metabolism impacts CRC risk in obesity.
The investigator's objective is to conduct a crossover controlled feeding trial of: 1) a "Typical American" diet with "high" heme/non-heme iron", 2) a "Typical American" diet with "low" iron, and 3) a Mediterranean diet with "high" non heme iron and examine effects on colonic and systemic inflammation and the gut microbiome.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 1. Typical American Diet with "high" heme/non-heme iron (16 mg) 2. Typical American Diet with "low" iron (8 mg) 3. Plant-based Diet with "high" non-heme iron (16 mg)
| Arm | Type | Receives |
|---|---|---|
| High heme iron diet | Other | Other: High heme iron diet |
| Low iron diet | Other | Other: Low iron diet |
| Plant-based high non-heme iron diet | Other | Other: Plant-based high non-heme iron diet |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Self-identify as Hispanic, African American, or Caucasian.
- Meet body mass index (BMI > = 30.0 kg/m2) and C-reactive protein (CRP) criteria (> 2.0 mg/dl)
- Post-menopausal (no menstruation in the past 12 months)
- Weight stable (< 3% weight change in the past 3 months)
- Non-smoker
Key exclusion criteria (17 listed)
- Chronic constipation (less than three stools per week for several months)
- History or intestinal cancer, inflammatory bowel disease, celiac disease, or malabsorptive bariatric surgery
- Previous intestinal surgery
- H pylori infection or taking H2 blockers (e.g., Zantac, Pepcid) /antacids (e.g., Rolaids) more than 3 times per week
- Significant blood loss or blood donation in past 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High heme iron dietA "Typical American" diet with "high" heme/non-heme iron" (18 mg total). Diet is isocaloric and has a macronutrient composition of total fat 35%, carbohydrates 50%, protein 15% of calories and fiber 9g/1000 calories. Subjects consumes the diet for 3 weeks with a minimum 3 week washout before the next diet. | Other | High heme iron diet |
| Low iron dietA "Typical American" diet with "low" heme/non-heme iron" (8 mg total). Diet is isocaloric and has a macronutrient composition of total fat 35%, carbohydrates 50%, protein 15% of calories and fiber 9g/1000 calories. Subjects consumes the diet for 3 weeks with a minimum 3 week washout before the next diet. | Other | Low iron diet |
| Plant-based high non-heme iron dietA plant-based diet with "high" non-heme iron" (18 mg total). Diet is isocaloric and has a macronutrient composition of total fat 35%, carbohydrates 50%, protein 15% of calories and fiber 9g/1000 calories. Subjects consumes the diet for 3 weeks with a minimum 3 week washout before the next diet. | Other | Plant-based high non-heme iron diet |
Primary outcome
Change in colonic inflammation
Time frame: Baseline and post-diet (day 22) for each of the three 3-week diets
Fecal calprotectin, a proxy for colon tissue inflammation, will be measured from stool an calprotectin immunoassay
3 secondary outcomes
Change in systemic inflammation
Time frame: Baseline and post-diet (day 22) for each of the three 3-week diets
Change in stool microbial community profile at the phylum and genus level
Time frame: Baseline and post-diet (day 22) for each of the three 3-week diets
Change in serum hepcidin
Time frame: Baseline and post-diet (day 22) for each of the three 3-week diets
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Tussing-Humphreys, PhD, MS, RD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High heme iron diet, Low iron diet and Plant-based high non-heme iron diet in people with Colon Inflammation and Iron Malabsorption, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in colonic inflammation (time frame: Baseline and post-diet (day 22) for each of the three 3-week diets). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2019.