Barrett's Esophagus, Obesity
Conditions
Keywords
Omega-3 fatty acid
Brief summary
This study is being done to understand the effect of dietary omega-3 fats in decreasing tissue inflammation in Barrett's esophagus.
Interventions
3 capsules a day of Omega 3 polyunsaturated fatty acids taken orally for six months; 2 capsules with breakfast and 1 capsule with their evening meal. Active drug will consist of 1200 mg of a ω3 FFA preparation containing 675 mg EPA and 300 mg DHA.
DRUGPlacebo
3 capsules a day of placebo (1200 mg of ethyl oleate 3 capsules a day) taken orally for six months; 2 capsules with breakfast and 1 capsule with their evening meal.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Presence of BE defined as ≥ 1 cm of visible columnar mucosa in the distal esophagus with intestinal metaplasia on histology. * Absence of high grade dysplasia or EAC on baseline histology. * BMI \> 30 kg/m2 or waist circumference \> 102 cm in men, \> 88 cm in women. * Ability to give informed consent.
Exclusion criteria
* Allergy to ω3 FFAs, fish or shellfish. * Presence of high grade dysplasia or cancer on histology. * Pregnant and or breastfeeding women * Presence of esophagitis on initial endoscopy or symptoms of refractory GERD (heartburn or regurgitation ≥ 2 times a week) indicative of uncontrolled gastroesophageal reflux. * Inability to give informed consent. * Currently taking Omega3 FFA as prescription. * Anti-coagulant therapy (Plavix, Warfarin, Coumadin) * AST or ALT level \> three times upper limit of normal at baseline * LDL \> 200 mg/dl at baseline. * INR \> 2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Serum PGE2 Levels | Baseline, 6 months | Percent change from baseline to 6 months in serum prostaglandin E2 (PGE2) level obtained from blood draw |
| Change in Esophageal Tissue PGE2 Levels | Baseline, 6 months | Percent change from baseline to 6 months in esophageal tissue prostaglandin E2 (PGE2) level obtained from endoscopic esophageal tissue collection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Esophageal Macrophage Markers | Baseline, 6 months | Percent change from baseline to 6 months in esophageal macrophage markers MCP-1 (Pro-inflammatory, M1 marker), CD 206 (Anti-inflammatory, M2 marker), and IL-10 (Anti-inflammatory, M2 marker) obtained from endoscopic esophageal tissue collection |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Subjects with known Barrett's Esophagus (no dysplasia and low-grade dysplasia) will receive a placebo which looks exactly like the study drug, but contains no active ingredient, to be taken orally for six months.
Placebo: 3 capsules a day of placebo (1200 mg of ethyl oleate 3 capsules a day) taken orally for six months; 2 capsules with breakfast and 1 capsule with their evening meal. | 30 |
| Omega-3 Polyunsaturated Fatty Acids Subjects with known Barrett's Esophagus (no dysplasia and low-grade dysplasia) will receive Omega-3 free fatty acids supplements to be taken orally for six months.
Omega-3 polyunsaturated fatty acids: 3 capsules a day of Omega 3 polyunsaturated fatty acids taken orally for six months; 2 capsules with breakfast and 1 capsule with their evening meal. Active drug will consist of 1200 mg of a ω3 FFA preparation containing 675 mg EPA and 300 mg DHA. | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Omega-3 Polyunsaturated Fatty Acids | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 66.5 years | 66 years | 66 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 30 participants | 60 participants | 30 participants |
| Sex: Female, Male Female | 11 Participants | 16 Participants | 5 Participants |
| Sex: Female, Male Male | 19 Participants | 44 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 1 / 30 | 2 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Change in Esophageal Tissue PGE2 Levels
Percent change from baseline to 6 months in esophageal tissue prostaglandin E2 (PGE2) level obtained from endoscopic esophageal tissue collection
Time frame: Baseline, 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Change in Esophageal Tissue PGE2 Levels | 0.82 Percentage of change in esophageal PGE2 |
| Omega-3 Polyunsaturated Fatty Acids | Change in Esophageal Tissue PGE2 Levels | 11.87 Percentage of change in esophageal PGE2 |
Primary
Change in Serum PGE2 Levels
Percent change from baseline to 6 months in serum prostaglandin E2 (PGE2) level obtained from blood draw
Time frame: Baseline, 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Change in Serum PGE2 Levels | 4.44 Percentage of change in serum PGE2 level |
| Omega-3 Polyunsaturated Fatty Acids | Change in Serum PGE2 Levels | -21.65 Percentage of change in serum PGE2 level |
Secondary
Change in Esophageal Macrophage Markers
Percent change from baseline to 6 months in esophageal macrophage markers MCP-1 (Pro-inflammatory, M1 marker), CD 206 (Anti-inflammatory, M2 marker), and IL-10 (Anti-inflammatory, M2 marker) obtained from endoscopic esophageal tissue collection
Time frame: Baseline, 6 months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Change in Esophageal Macrophage Markers | MCP-1 (Pro-inflammatory, M1 marker) | 4.81 Percentage change in macrophage markers |
| Placebo | Change in Esophageal Macrophage Markers | CD 206 (Anti-inflammatory, M2 marker) | 4.19 Percentage change in macrophage markers |
| Placebo | Change in Esophageal Macrophage Markers | IL-10 (Anti-inflammatory M2 marker) | 1.91 Percentage change in macrophage markers |
| Omega-3 Polyunsaturated Fatty Acids | Change in Esophageal Macrophage Markers | MCP-1 (Pro-inflammatory, M1 marker) | 2.12 Percentage change in macrophage markers |
| Omega-3 Polyunsaturated Fatty Acids | Change in Esophageal Macrophage Markers | CD 206 (Anti-inflammatory, M2 marker) | 2.00 Percentage change in macrophage markers |
| Omega-3 Polyunsaturated Fatty Acids | Change in Esophageal Macrophage Markers | IL-10 (Anti-inflammatory M2 marker) | -0.53 Percentage change in macrophage markers |