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Phase Ib Study of the Effects of Omega-3 Supplementation on Fatty Acid Metabolism in the Colon

Phase 1
25 Years
75 Years
Open (Enrolling)
Physiological Effects of Fish Oil

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Trial Information

Phase Ib Study of the Effects of Omega-3 Supplementation on Fatty Acid Metabolism in the Colon

Inclusion Criteria:

- 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

- 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

- Have a normal WBC, hemoglobin and platelet count, and renal and hepatic function
obtained within the last 28 days

Exclusion Criteria:

- • 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Change in PGE2 levels in colon mucosa

Outcome Description:

Quantitate the amount of PGE2 in colon mucosa before and after 5 months of Fish Oil

Outcome Time Frame:

5 months

Safety Issue:



United States: Institutional Review Board

Study ID:




Start Date:

May 2013

Completion Date:

December 2014

Related Keywords:

  • Physiological Effects of Fish Oil
  • Fish Oil
  • colon health
  • fatty acid metabolism



University of MichiganAnn Arbor, Michigan  48109-0624