Adverse EffectsNCT01471366
Method of Fish Oil Administration on Patient Compliance
A study testing Frozen capsule, Capsule with food and Capsule without food in people with Adverse Effects, run by University of Mississippi, Oxford at 1 site in United States.
Trial summary
Many patients complain of fishy breath, upset stomach, or heartburn when taking the recommended amount of fish oil. A common recommendation made by pharmacists is to freeze the fish oil capsules to help decrease adverse gastrointestinal effects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Adverse Effects
- What is being tested?
- Frozen capsule, Capsule with food and Capsule without food
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Jul 2014
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients 18-65 years of age
- Minimal medication usage and controlled chronic health conditions
Who cannot join
- Patients with significant renal, hepatic, autoimmune or gastrointestinal tract disease
- Patients with uncontrolled chronic health conditions (e.g., diabetes, high blood pressure, high cholesterol or hypothyroidism)
- Receiving prescription anti-coagulation, prescription anti-platelet, prescription anti-inflammatory drugs, biologics, chronic steroids, chemotherapy, or otherwise excessive medication regimens
- Pregnant/nursing women, <18 years of age, prisoners, or the mentally ill
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mississippi School of Pharmacy
Jackson, Mississippi, 39216
About this study
Official title: What is the Best Way to Take Fish Oil?
Many patients complain of fishy breath, upset stomach, or heartburn when taking the recommended amount of fish oil. A common recommendation made by pharmacists is to freeze the fish oil capsules to help decrease adverse gastrointestinal effects. Compliance with over-the-counter (OTC) fish oil is a concern considering the high number of capsules taken daily. The hypothesis of this study is that taking fish oil with milk will help lead to better patient compliance with no difference in adverse effects versus other administration methods.
Read the detailed description
Fish oil has many proposed health benefits such as lowering triglycerides, decreasing inflammation, and reducing risk factors for cardiovascular disease. In order to take the recommended daily dose for hypertriglyceridemia using an OTC fish oil supplement, the daily recommended dose is at least 2 grams (2 capsules) three times a day. The American Heart Association recommends 2-4 grams of omega-3 fatty acid a day to aid in triglyceride reduction. Fish oil is known to cause GI-related adverse effects. Although reported to help, freezing fish oil capsules is inconvenient requiring access to a freezer three times a day. Currently there is a lack of literature to specify the best administration technique or patient compliance data for OTC fish oil supplements. The purpose of this study is to determine an ideal method of taking fish oil. This study will include up to 60 patients that are between the ages of 18-65 years who would be considered generally healthy. Patients will be recruited via e-mails sent to faculty and students of the School of Pharmacy, via flyers in Walgreen's stores, and through word of mouth. The patients will be randomly assigned to one of four treatment groups. Each treatment group will be given 180 capsules and instructed to take two capsules three times a day for thirty days with either food, no food, milk, or frozen. At the end of thirty days, the patient will return the bottle with any remaining pills to the investigator and take a survey. The investigators will assess compliance via pill count.
- Conditions
- Adverse Effects
- Being tested
- Frozen capsule, Capsule with food, Capsule without food, Capsule with milk
- Keywords
- Hyperlipidemias, Dyslipidemias, Fatty Acids, Omega-3, Fish Oils
- Medical subject headings
- Hyperlipidemias, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frozen capsuleDietary supplement
Also called Fish Oil Concentrate, Natural Fish Oil
Two frozen fish oil capsules (300 mg EPA/DHA per capsule) by mouth three times daily with 8 ounces of water without food or dairy products.
Capsule with foodDietary supplement
Also called Fish Oil Concentrate, Natural Fish Oil
Two room temperature fish oil capsules (300 mg EPA/DHA per capsule) by mouth three times daily with 8 ounces of water with food but no dairy products
Capsule without foodDietary supplement
Also called Fish Oil Concentrate, Natural Fish Oil
Two room temperature fish oil capsules (300 mg EPA/DHA per capsule) by mouth three times daily with 8 ounces of water with no food or dairy products
Capsule with milkDietary supplement
Also called Fish Oil Concentrate, Natural Fish Oil
Two room temperature fish oil capsules (300 mg EPA/DHA per capsule) by mouth three times daily with 8 ounces of milk with no food or additional dairy products
| Study group | Role | What they receive |
|---|---|---|
| Frozen capsule | Active comparator | Two frozen fish oil capsules (300 mg EPA/DHA per capsule) by mouth three times daily with 8 ounces of water without food or dairy products Receives: Dietary Supplement: Frozen capsule |
| Capsule with food | Active comparator | Two room temperature fish oil capsules (300 mg EPA/DHA per capsule) by mouth three times daily with 8 ounces of water with food but no dairy products Receives: Dietary Supplement: Capsule with food |
| Capsule without food | Active comparator | Two room temperature fish oil capsules (300 mg EPA/DHA per capsule) by mouth three times daily with 8 ounces of water with no food or dairy products Receives: Dietary Supplement: Capsule without food |
| Capsule with milk | Active comparator | Two room temperature fish oil capsules (300 mg EPA/DHA per capsule) by mouth three times daily with 8 ounces of milk with no food or additional dairy products Receives: Dietary Supplement: Capsule with milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Effects
Subjective survey based patient reported adverse effects
Measured: 4 weeks
Secondary outcomes (1)
Compliance
Pill count will be performed to assess medication compliance.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Adverse EffectsStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi, Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Walgreens
- Responsible party
- Principal investigator, Daniel Riche, University of Mississippi, Oxford
- Investigators
- Daniel M Riche, Pharm.D., Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01471366
- Sponsor's protocol ID
- UMO-0003
- Status last verified
- Jul 2014
- First submitted
- 10 Nov 2011
- Last updated
- 28 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Oelrich B, Dewell A, Gardner CD. Effect of fish oil supplementation on serum triglycerides, LDL cholesterol and LDL subfractions in hypertriglyceridemic adults. Nutr Metab Cardiovasc Dis. 2013 Apr;23(4):350-7. doi: 10.1016/j.numecd.2011.06.003. Epub 2011 Sep 15.
PubMed 21924882Eslick GD, Howe PR, Smith C, Priest R, Bensoussan A. Benefits of fish oil supplementation in hyperlipidemia: a systematic review and meta-analysis. Int J Cardiol. 2009 Jul 24;136(1):4-16. doi: 10.1016/j.ijcard.2008.03.092. Epub 2008 Sep 6.
PubMed 18774613Kris-Etherton PM, Harris WS, Appel LJ; American Heart Association. Nutrition Committee. Fish consumption, fish oil, omega-3 fatty acids, and cardiovascular disease. Circulation. 2002 Nov 19;106(21):2747-57. doi: 10.1161/01.cir.0000038493.65177.94. No abstract available.
PubMed 12438303Dietary supplementation with n-3 polyunsaturated fatty acids and vitamin E after myocardial infarction: results of the GISSI-Prevenzione trial. Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto miocardico. Lancet. 1999 Aug 7;354(9177):447-55.
PubMed 10465168Miller M, Stone NJ, Ballantyne C, Bittner V, Criqui MH, Ginsberg HN, Goldberg AC, Howard WJ, Jacobson MS, Kris-Etherton PM, Lennie TA, Levi M, Mazzone T, Pennathur S; American Heart Association Clinical Lipidology, Thrombosis, and Prevention Committee of the Council on Nutrition, Physical Activity, and Metabolism; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular Nursing; Council on the Kidney in Cardiovascular Disease. Triglycerides and cardiovascular disease: a scientific statement from the American Heart Association. Circulation. 2011 May 24;123(20):2292-333. doi: 10.1161/CIR.0b013e3182160726. Epub 2011 Apr 18. No abstract available.
PubMed 21502576Zabel R, Ash S, King N, Bauer J. Adherence to fish oil intervention in patients with chronic kidney disease. J Ren Nutr. 2010 Sep;20(5):329-33. doi: 10.1053/j.jrn.2010.01.003. Epub 2010 Mar 19.
PubMed 20303787Malinowski SS, Barber KE, Kishk OA, Mays AA, Jones SR, Turner AL, Riche DM. Effect of fish oil supplement administration method on tolerability and adherence: a randomized pilot clinical trial. Pilot Feasibility Stud. 2019 Jan 8;5:3. doi: 10.1186/s40814-018-0387-0. eCollection 2019.
PubMed 30637118
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is the Best Way to Take Fish Oil?
- ClinicalTrials.gov ID
- NCT01471366
- Acronym / sponsor ID
- UMO-0003
- Conditions
- Adverse Effects
- Keywords
- Hyperlipidemias, Dyslipidemias, Fatty Acids, Omega-3, Fish Oils
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Mississippi, OxfordUniversity, hospital or other
- Collaborators
- Walgreens
- Study start
- Nov 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 16 Nov 2011 (estimated)
- 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.
Many patients complain of fishy breath, upset stomach, or heartburn when taking the recommended amount of fish oil. A common recommendation made by pharmacists is to freeze the fish oil capsules to help decrease adverse gastrointestinal effects. Compliance with over-the-counter (OTC) fish oil is a concern considering the high number of capsules taken daily. The hypothesis of this study is that taking fish oil with milk will help lead to better patient compliance with no difference in adverse effects versus other administration methods.
Detailed description
Fish oil has many proposed health benefits such as lowering triglycerides, decreasing inflammation, and reducing risk factors for cardiovascular disease. In order to take the recommended daily dose for hypertriglyceridemia using an OTC fish oil supplement, the daily recommended dose is at least 2 grams (2 capsules) three times a day. The American Heart Association recommends 2-4 grams of omega-3 fatty acid a day to aid in triglyceride reduction. Fish oil is known to cause GI-related adverse effects. Although reported to help, freezing fish oil capsules is inconvenient requiring access to a freezer three times a day. Currently there is a lack of literature to specify the best administration technique or patient compliance data for OTC fish oil supplements. The purpose of this study is to determine an ideal method of taking fish oil. This study will include up to 60 patients that are between the ages of 18-65 years who would be considered generally healthy. Patients will be recruited via e-mails sent to faculty and students of the School of Pharmacy, via flyers in Walgreen's stores, and through word of mouth. The patients will be randomly assigned to one of four treatment groups. Each treatment group will be given 180 capsules and instructed to take two capsules three times a day for thirty days with either food, no food, milk, or frozen. At the end of thirty days, the patient will return the bottle with any remaining pills to the investigator and take a survey. The investigators will assess compliance via pill count.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Frozen capsule | Active comparator | Dietary Supplement: Frozen capsuleTwo frozen fish oil capsules (300 mg EPA/DHA per capsule) by mouth three times daily with 8 ounces of water without food or dairy products |
| Capsule with food | Active comparator | Dietary Supplement: Capsule with foodTwo room temperature fish oil capsules (300 mg EPA/DHA per capsule) by mouth three times daily with 8 ounces of water with food but no dairy products |
| Capsule without food | Active comparator | Dietary Supplement: Capsule without foodTwo room temperature fish oil capsules (300 mg EPA/DHA per capsule) by mouth three times daily with 8 ounces of water with no food or dairy products |
| Capsule with milk | Active comparator | Dietary Supplement: Capsule with milkTwo room temperature fish oil capsules (300 mg EPA/DHA per capsule) by mouth three times daily with 8 ounces of milk with no food or additional dairy products |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients 18-65 years of age
- Minimal medication usage and controlled chronic health conditions
Key exclusion criteria (4 listed)
- Patients with significant renal, hepatic, autoimmune or gastrointestinal tract disease
- Patients with uncontrolled chronic health conditions (e.g., diabetes, high blood pressure, high cholesterol or hypothyroidism)
- Receiving prescription anti-coagulation, prescription anti-platelet, prescription anti-inflammatory drugs, biologics, chronic steroids, chemotherapy, or otherwise excessive medication regimens
- Pregnant/nursing women, <18 years of age, prisoners, or the mentally ill
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 |
|---|---|---|
| Frozen capsuleAlso: Fish Oil Concentrate, Natural Fish OilTwo frozen fish oil capsules (300 mg EPA/DHA per capsule) by mouth three times daily with 8 ounces of water without food or dairy products. | Dietary supplement | Frozen capsule |
| Capsule with foodAlso: Fish Oil Concentrate, Natural Fish OilTwo room temperature fish oil capsules (300 mg EPA/DHA per capsule) by mouth three times daily with 8 ounces of water with food but no dairy products | Dietary supplement | Capsule with food |
| Capsule without foodAlso: Fish Oil Concentrate, Natural Fish OilTwo room temperature fish oil capsules (300 mg EPA/DHA per capsule) by mouth three times daily with 8 ounces of water with no food or dairy products | Dietary supplement | Capsule without food |
| Capsule with milkAlso: Fish Oil Concentrate, Natural Fish OilTwo room temperature fish oil capsules (300 mg EPA/DHA per capsule) by mouth three times daily with 8 ounces of milk with no food or additional dairy products | Dietary supplement | Capsule with milk |
Primary outcome
Adverse Effects
Time frame: 4 weeks
Subjective survey based patient reported adverse effects
1 secondary outcome
Compliance
Time frame: 4 weeks
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 28 Jul 2014.
- Background: PubMed 21924882Oelrich B, Dewell A, Gardner CD. Effect of fish oil supplementation on serum triglycerides, LDL cholesterol and LDL subfractions in hypertriglyceridemic adults. Nutr Metab Cardiovasc Dis. 2013 Apr;23(4):350-7. doi: 10.1016/j.numecd.2011.06.003. Epub 2011 Sep 15.
- Background: PubMed 18774613Eslick GD, Howe PR, Smith C, Priest R, Bensoussan A. Benefits of fish oil supplementation in hyperlipidemia: a systematic review and meta-analysis. Int J Cardiol. 2009 Jul 24;136(1):4-16. doi: 10.1016/j.ijcard.2008.03.092. Epub 2008 Sep 6.
- Background: PubMed 12438303Kris-Etherton PM, Harris WS, Appel LJ; American Heart Association. Nutrition Committee. Fish consumption, fish oil, omega-3 fatty acids, and cardiovascular disease. Circulation. 2002 Nov 19;106(21):2747-57. doi: 10.1161/01.cir.0000038493.65177.94. No abstract available.
- Background: PubMed 10465168Dietary supplementation with n-3 polyunsaturated fatty acids and vitamin E after myocardial infarction: results of the GISSI-Prevenzione trial. Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto miocardico. Lancet. 1999 Aug 7;354(9177):447-55.
- Background: PubMed 21502576Miller M, Stone NJ, Ballantyne C, Bittner V, Criqui MH, Ginsberg HN, Goldberg AC, Howard WJ, Jacobson MS, Kris-Etherton PM, Lennie TA, Levi M, Mazzone T, Pennathur S; American Heart Association Clinical Lipidology, Thrombosis, and Prevention Committee of the Council on Nutrition, Physical Activity, and Metabolism; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular Nursing; Council on the Kidney in Cardiovascular Disease. Triglycerides and cardiovascular disease: a scientific statement from the American Heart Association. Circulation. 2011 May 24;123(20):2292-333. doi: 10.1161/CIR.0b013e3182160726. Epub 2011 Apr 18. No abstract available.
- Background: PubMed 20303787Zabel R, Ash S, King N, Bauer J. Adherence to fish oil intervention in patients with chronic kidney disease. J Ren Nutr. 2010 Sep;20(5):329-33. doi: 10.1053/j.jrn.2010.01.003. Epub 2010 Mar 19.
- Derived from this study: PubMed 30637118Malinowski SS, Barber KE, Kishk OA, Mays AA, Jones SR, Turner AL, Riche DM. Effect of fish oil supplement administration method on tolerability and adherence: a randomized pilot clinical trial. Pilot Feasibility Stud. 2019 Jan 8;5:3. doi: 10.1186/s40814-018-0387-0. eCollection 2019.
Related trials for Adverse Effects
Active, not recruitingPhase 2
A Study of Anakinra to Prevent or Treat Severe Side Effects for Patients Receiving CAR-T Cell Therapy
B Cell ALL, B-Cell Lymphoma
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
Not yet recruitingPhase 2
The CARDIOPROTECT Trial
Diffuse Large B-cell Lymphoma (DLBCL), Cardiotoxicity
RecruitingPhase 4
Hematological Safety of Dipyrone Versus Paracetamol After Dental Extractions
Hematologic Test, Agranulocytosis
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
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.
Daniel M Riche, Pharm.D. principal investigator
University of Mississippi Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Frozen capsule, Capsule with food and Capsule without food in people with Adverse Effects, run by University of Mississippi, Oxford 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 2 inclusion and 4 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 28 Jul 2014. 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?
Adverse Effects (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01471366, which also lists 7 linked publications.
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 28 Jul 2014.