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Obesity, Iron Regulation and Colorectal Cancer Risk

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ClinicalTrials.gov Identifier: NCT03548948
Recruitment Status : Active, not recruiting
First Posted : June 7, 2018
Last Update Posted : October 5, 2018
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
University of Illinois at Chicago

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Colon Inflammation Iron Malabsorption Obesity Diet Modification Other: High heme iron diet Other: Low iron diet Other: Plant-based high non-heme iron diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention 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)
Primary Purpose: Other
Official Title: Obesity, Iron Regulation and Colorectal Cancer Risk
Actual Study Start Date : July 15, 2015
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
High heme iron diet Other: High heme iron diet
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 diet Other: Low iron diet
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 diet Other: Plant-based high non-heme iron diet
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Change in systemic inflammation [ Time Frame: Baseline and post-diet (day 22) for each of the three 3-week diets ]
    Circulating C-reactive protein, Interleukin-6 (IL-6) and Tumor necrosis factor-alpha (TNF-a) will be measured from serum using immunoassays.

  2. 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 ]
    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.

  3. Change in serum hepcidin [ Time Frame: Baseline and post-diet (day 22) for each of the three 3-week diets ]
    Serum hepcidin will be measured using an immunoassay



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Ages Eligible for Study:   55 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03548948


Locations
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United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60608
Sponsors and Collaborators
University of Illinois at Chicago
American Cancer Society, Inc.
Investigators
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Principal Investigator: Lisa Tussing-Humphreys, PhD, MS, RD University of Illinois at Chicago

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Responsible Party: University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT03548948     History of Changes
Other Study ID Numbers: 2014-0721
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Obesity
Colorectal Neoplasms
Inflammation
Malabsorption Syndromes
Colitis
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pathologic Processes
Metabolic Diseases
Gastroenteritis
Iron
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs