Status:
COMPLETED
Effects of Fish Oil on the Colon Mucosa
Lead Sponsor:
University of Michigan
Conditions:
Physiological Effects of Fish Oil
Eligibility:
All Genders
25-75 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to see what effects the dietary supplement called Omega-3 or "Fish Oil" and it has on your colon, if any. Omega-3 (Fish Oil) is available in many forms (pills, capsules, l...
Eligibility Criteria
Inclusion
- Men and women who are between the ages of 25 and 75.
- The subject has been properly informed of the study and signed the informed Consent document(s).
- BMI is between 18 to 40.0 kg/m2
- Pre-menopausal women with intact female reproductive organs must have a negative pregnancy test within 2 weeks of the baseline flexible sigmoidoscopy. Post-menopausal is defined as no menses for the previous 12 months. If cessation of menses is within 12 months then the subject should be treated as pre-menopausal and a pregnancy test performed.
- Have a normal WBC, hemoglobin and platelet count, and renal and hepatic function obtained within the last 28 days
Exclusion
- • Pregnant or lactating women or women contemplating pregnancy for the duration of the protocol.
- Taking any of the following chronic medications:
- Insulin or oral hypoglycemics
- Anti-coagulants (or off 3 months prior to study start)
- Lovaza™ (prescription fish oil)
- Chronic NSAID use (including daily 325 mg or more of aspirin) or willing to go off NSAIDS for 3 weeks prior to enrollment to end of study (tDay 84)
- Steroids (except inhaled steroids for asthma)
- Other medications that may affect the biomarkers of interest
- Any supplement use (i.e. High dose vitamins, fish oils, other oils) that can affect the biomarkers of interest. Potential subjects will be given the option of participating if they agree to a 3-week wash-out period before starting on study and to avoid such supplements while on study.
- Has a history of any prior cancer diagnosed within the last 5 years except for basal cell or squamous cell tumors of the skin that have been surgically excised.
- Unable to read, write, or understand English.
- Unable to give informed consent.
- Subjects with a history of symptomatic chronic cardiovascular (NYHA Stage III or greater), renal, or liver disease as defined by variation from laboratory values in the inclusion criteria.
- Blood pressure ≥ 150/95 (manual reading).
- Unwilling to avoid intake of non-steroidal anti-inflammatory agents or corticosteroids over a 3 week period prior to study or during the entire study period.
- Showing evidence of lack of reliability or nonadherence (for example, missing a screening or enrollment appointment more than twice)
- Has a history of or known case of colonic disease such as colon cancer, Crohn's disease, ulcerative colitis, Familial Adenoma Polyposis (FAP), or Hereditary nonpolyposis colorectal adenocarcinoma (HNPCC).
- Known HIV or Hepatitis C
- Allergies to fish or fish oil
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01860352
Start Date
May 1 2013
End Date
October 1 2016
Last Update
March 1 2017
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109