ObesityOXBIONCT03583281
Effects of Dietary Fatty Acids on Octadecanoid Production and Biological Actions in Obesity-induced Inflammation
A study testing Capsules containing flax oil and Capsules containing DHA-enriched fish oil in people with Obesity and Inflammation, run by University of Manitoba at 1 site in Canada.
Trial summary
This is a single site, double-blind, randomized, crossover study designed to compare the effects of dietary supplementation with flax oil rich in alpha-linolenic acid (ALA) and fish oil rich in docosahexaenoic acid (DHA) on oxylipin profiles over time (0 to 4 weeks) and among obese females varying in their… Read more about this study
- Who is it for?
- Ages 20 to 55 years, women only
- Conditions the study is for
- Obesity, Inflammation
- What is being tested?
- Capsules containing flax oil and Capsules containing DHA-enriched fish oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2018to 30 Apr 2021
- 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 20 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Non-pregnant, non-lactating premenopausal female, >20 and <55 years of age (females of child bearing potential must take adequate birth control measures through the trial, and if a female becomes pregnant during the study, they must immediately stop taking the study oil capsules and be withdrawn from the study);
- Fasting LDL-cholesterol ≤4.5 mmol/L and triglycerides ≤4.5 mmol/L (management with cholesterol-lowering and triglyceride-lowering medications is acceptable), plasma creatinine ≤265 µmol/L, AST <5× upper limit of normal (ULN) where the normal range is 10 - 32 U/L, ALT <5× ULN where the normal range is <25 U/L for females and <30 U/L for males, and glycated hemoglobin <6.5%;
- Blood pressure <160/100 (management with anti-hypertensive medications is acceptable);
- BMI ≥30, and waist circumference >94 cm for males and >80 cm for females of Asian ethnicity, and >102 cm for males and >88 cm for females of non-Asian ethnicity;
- Stable regime if taking vitamin and mineral/dietary/herbal supplements for the past 1 month and while participating in the study;
- Willing to maintain a stable level of activity while participating in the study;
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- Willing to maintain dietary routine and to refrain from consuming omega-3 supplements or omega-3 rich foods (>0.3 grams ALA/serving, or >0.1 grams EPA + DHA/serving), and to refrain from anti-inflammatory natural health products, from acceptance into the study until the final study visit;
- Females must have normal menses and can be on birth control;
- Agrees to not donate blood or blood products (e.g. platelets) while participating in the study and for 2 months after participation in the study;
- Willing to comply with the protocol requirements and procedures;
- Willing to provide informed consent.
Who cannot join
- Has experienced a cardiovascular event (e.g. heart attack, stroke) or had a surgical procedure for cardiovascular disease (e.g. bypass, stent), presence of diabetes, chronic renal disease, liver disease (with exception of fatty liver), rheumatoid arthritis, immune disorder or disease (e.g. multiple sclerosis, leukemia), cancer in the previous 5 years, neurological disorders, gastrointestinal disorders or gastrointestinal surgery or bariatric surgery, or liposuction, or experiences migraines;
- Taking medications for inflammation, pain or arthritis (e.g. cyclooxygenase (COX) inhibitors, steroids such as cortisone and prednisone), medications for blood glucose management, anti-coagulants/blood thinners, low dose acetylsalicylic acid, medication for erectile dysfunction (e.g. Viagra), within the last 3 months;
- Regular use (> one day per week during two or more weeks) of acetylsalicylic acid (e.g. Aspirin), ibuprofen (e.g. Advil) or over-the-counter anti-inflammatory products such as Naproxen (e.g. Aleve, Midol Extended Relief) or those containing steroids such as cortisone and prednisone, within the last 3 months or while participating in the study;
- Regular use (>three days per week during menstruation or >one day per week during two or more other weeks) of acetaminophen (e.g. Tylenol, Midol), within the last 3 months or while participating in the study;
- Allergy or sensitivity to any of the study product ingredients, such as flax oil or flaxseed, fish oil or its sources such as fish or shellfish;
- Cigarette/cigar smoking or use of tobacco products within the past 12 months or during the study;
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- Body weight has not been stable (plus or minus 3 kg) over the past 6 months;
- Consumption of >15 alcoholic beverages per week (according to Canada's Low-Risk Alcohol Drinking Guidelines, 2012) within the last 3 months or while participating in the study;
- Current (within the past 30 days) bacterial, viral or fungal infection;
- Unable to obtain blood sample at the screening, week 0 visit, or two consecutive study visits;
- Donated blood or blood products (e.g. platelets) or had blood collected in the 2 months prior to participation the study.
Trial locations and contacts
1 site in 1 country.
Canada1 site
I.H. Asper Clinical Research Institute
Winnipeg, Manitoba, R2H 2A6
About this study
Official title: Effects of Dietary Fatty Acids on Octadecanoid Production and Biological Actions in Obesity-induced Inflammation: Implications for Dietary Requirements
This is a single site, double-blind, randomized, crossover study designed to compare the effects of dietary supplementation with flax oil rich in alpha-linolenic acid (ALA) and fish oil rich in docosahexaenoic acid (DHA) on oxylipin profiles over time (0 to 4 weeks) and among obese females varying in their inflammatory state. Additional assessments will include plasma fatty acid composition, adipokines, markers of adipocyte dysfunction and inflammation; immune cell/monocyte fatty acid composition, and functional properties including their metabolism and oxylipin production; and vascular function.
Read the detailed description
A single site, double-blind, randomized, cross-over study designed to compare the effects of flax oil and fish oil supplementation on the oxylipin profile in females with obesity (n=24). Eligible participants will complete two supplementation phases (flax oil and fish oil rich in DHA) and will be asked to attend 3 in-person clinic visits (0, 3, and 28 days) for blood and urine collection during each phase. In addition to oxylipin profiles, assessments will include plasma fatty acid composition, adipokines, markers of adipocyte dysfunction and inflammation; immune cell/monocyte fatty acid composition, and functional properties including their metabolism and oxylipin production; and vascular function. If participants sign an optional consent form, vaginal fluid samples will be obtained at 0 and 28 days of each Supplementation Phase and analyzed for oxylipin and immune cell profile.
- Conditions
- Obesity, Inflammation
- Being tested
- Capsules containing flax oil, Capsules containing DHA-enriched fish oil
- Medical subject headings
- Obesity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsules containing flax oilDietary supplement
Capsules containing flax oil to provide 4 grams ALA per day for 4 weeks
Capsules containing DHA-enriched fish oilDietary supplement
Capsules containing fish oil to provide 4 grams DHA per day and 0.8 grams EPA per day for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Flax oil | Active comparator | Participants will consume capsules containing flax oil (4 grams alpha-linolenic acid [ALA] per day) for 4 weeks Receives: Dietary Supplement: Capsules containing flax oil |
| Fish oil | Active comparator | Participants will consume capsules containing DHA-enriched fish oil (4 grams DHA per day + 0.8 grams EPA per day) for 4 weeks Receives: Dietary Supplement: Capsules containing DHA-enriched fish oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma oxylipin concentrations over time
A fasting venous blood sample will be obtained from participants on Days 0, 3 and 28 of each Supplementation Phase for the assessment of plasma oxylipin profile.
Measured: Baseline, 3 days, 28 days
Secondary outcomes (9)
Plasma fatty acid composition over time
A fasting venous blood sample will be obtained from participants on Days 0, 3 and 28 of each Supplementation Phase for the assessment of plasma fatty acid composition.
Measured: Baseline, 3 days, 28 days
Monocyte metabolism over time
A fasting venous blood sample will be obtained from participants on Days 0 and 28 of each Supplementation Phase Changes for isolation of monocytes and assessment of their metabolic characteristics evaluated by Seahorse.
Measured: Baseline, 28 days
Monocyte fatty acid composition over time
A fasting venous blood sample will be obtained from participants on Days 0 and 28 of each Supplementation Phase for isolation of monocytes and assessment of their fatty acid composition.
Measured: Baseline, 28 days
Peripheral blood mononuclear cell (PBMC) oxylipin and cytokine production over time
A fasting venous blood sample will be obtained from participants on Days 0, 3, and 28 of each Supplementation Phase Changes for isolation of PBMCs and assessment of oxylipin and cytokine production ex vivo
Measured: Baseline, 3 days, 28 days
Plasma adiponectin concentrations over time
A fasting venous blood sample will be obtained from participants on Days 0, 3 and 28 of each Supplementation Phase for the assessment of plasma adiponectin, an anti-inflammatory adipokine and marker of adipocyte dysfunction.
Measured: Baseline, 3 days, 28 days
Vascular function changes over time
Assessment of of vascular function using pulse wave velocity determined at Day 0 and 28 of each Supplementation Phase.
Measured: Baseline, 28 days
Plasma lipid profile, alanine aminotransferase (ALT), aspartate aminotransferase (AST), and creatinine over time
A fasting venous blood sample will be obtained from participants on Days 0, 3, and 28 of each Supplementation Phase for the assessment of plasma lipid profile, ALT, AST and creatinine
Measured: Baseline, 3 days, 28 days
Vaginal fluid oxylipin profile over time
If participants sign an optional consent form, vaginal fluid samples will be obtained at 0 and 28 days of each Supplementation Phase for assessment of the concentrations of oxylipins.
Measured: Baseline, 28 days
Vaginal fluid immune cell composition and function over time
If participants sign an optional consent form, vaginal fluid samples will be obtained at 0 and 28 days of each Supplementation Phase for characterization of immune cells by cell type and by functional assays for susceptibility to infection ex vivo.
Measured: Baseline, 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2018
- Study start1 Jun 2018
- Primary completion30 Apr 2020
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Obese females
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Carla G Taylor, PhD, Principal investigator, St Boniface Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03583281
- Sponsor's protocol ID
- H18926
- Acronym
- OXBIO
- Status last verified
- Jun 2021
- First submitted
- 15 Jun 2018
- Last updated
- 2 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pauls SD, Rodway LR, Sidhu KK, Winter T, Sidhu N, Aukema HM, Zahradka P, Taylor CG. Oils Rich in alpha-Linolenic Acid or Docosahexaenoic Acid Have Distinct Effects on Plasma Oxylipin and Adiponectin Concentrations and on Monocyte Bioenergetics in Women with Obesity. J Nutr. 2021 Oct 1;151(10):3053-3066. doi: 10.1093/jn/nxab235.
PubMed 34293124
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dietary Fatty Acids on Octadecanoid Production and Biological Actions in Obesity-induced Inflammation: Implications for Dietary Requirements
- ClinicalTrials.gov ID
- NCT03583281
- Acronym / sponsor ID
- OXBIO / H18926
- Conditions
- Obesity, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 11 Jul 2018 (actual)
- 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.
This is a single site, double-blind, randomized, crossover study designed to compare the effects of dietary supplementation with flax oil rich in alpha-linolenic acid (ALA) and fish oil rich in docosahexaenoic acid (DHA) on oxylipin profiles over time (0 to 4 weeks) and among obese females varying in their inflammatory state. Additional assessments will include plasma fatty acid composition, adipokines, markers of adipocyte dysfunction and inflammation; immune cell/monocyte fatty acid composition, and functional properties including their metabolism and oxylipin production; and vascular function.
Detailed description
A single site, double-blind, randomized, cross-over study designed to compare the effects of flax oil and fish oil supplementation on the oxylipin profile in females with obesity (n=24). Eligible participants will complete two supplementation phases (flax oil and fish oil rich in DHA) and will be asked to attend 3 in-person clinic visits (0, 3, and 28 days) for blood and urine collection during each phase. In addition to oxylipin profiles, assessments will include plasma fatty acid composition, adipokines, markers of adipocyte dysfunction and inflammation; immune cell/monocyte fatty acid composition, and functional properties including their metabolism and oxylipin production; and vascular function. If participants sign an optional consent form, vaginal fluid samples will be obtained at 0 and 28 days of each Supplementation Phase and analyzed for oxylipin and immune cell profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Obese females
| Arm | Type | Receives |
|---|---|---|
| Flax oil | Active comparator | Dietary Supplement: Capsules containing flax oilParticipants will consume capsules containing flax oil (4 grams alpha-linolenic acid [ALA] per day) for 4 weeks |
| Fish oil | Active comparator | Dietary Supplement: Capsules containing DHA-enriched fish oilParticipants will consume capsules containing DHA-enriched fish oil (4 grams DHA per day + 0.8 grams EPA per day) for 4 weeks |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Non-pregnant, non-lactating premenopausal female, >20 and <55 years of age (females of child bearing potential must take adequate birth control measures through the trial, and if a female becomes pregnant during the study, they must immediately stop taking the study oil capsules and be withdrawn from the study);
- Fasting LDL-cholesterol ≤4.5 mmol/L and triglycerides ≤4.5 mmol/L (management with cholesterol-lowering and triglyceride-lowering medications is acceptable), plasma creatinine ≤265 µmol/L, AST <5× upper limit of normal (ULN) where the normal range is 10 - 32 U/L, ALT <5× ULN where the normal range is <25 U/L for females and <30 U/L for males, and glycated hemoglobin <6.5%;
- Blood pressure <160/100 (management with anti-hypertensive medications is acceptable);
- BMI ≥30, and waist circumference >94 cm for males and >80 cm for females of Asian ethnicity, and >102 cm for males and >88 cm for females of non-Asian ethnicity;
- Stable regime if taking vitamin and mineral/dietary/herbal supplements for the past 1 month and while participating in the study;
Key exclusion criteria (11 listed)
- Has experienced a cardiovascular event (e.g. heart attack, stroke) or had a surgical procedure for cardiovascular disease (e.g. bypass, stent), presence of diabetes, chronic renal disease, liver disease (with exception of fatty liver), rheumatoid arthritis, immune disorder or disease (e.g. multiple sclerosis, leukemia), cancer in the previous 5 years, neurological disorders, gastrointestinal disorders or gastrointestinal surgery or bariatric surgery, or liposuction, or experiences migraines;
- Taking medications for inflammation, pain or arthritis (e.g. cyclooxygenase (COX) inhibitors, steroids such as cortisone and prednisone), medications for blood glucose management, anti-coagulants/blood thinners, low dose acetylsalicylic acid, medication for erectile dysfunction (e.g. Viagra), within the last 3 months;
- Regular use (> one day per week during two or more weeks) of acetylsalicylic acid (e.g. Aspirin), ibuprofen (e.g. Advil) or over-the-counter anti-inflammatory products such as Naproxen (e.g. Aleve, Midol Extended Relief) or those containing steroids such as cortisone and prednisone, within the last 3 months or while participating in the study;
- Regular use (>three days per week during menstruation or >one day per week during two or more other weeks) of acetaminophen (e.g. Tylenol, Midol), within the last 3 months or while participating in the study;
- Allergy or sensitivity to any of the study product ingredients, such as flax oil or flaxseed, fish oil or its sources such as fish or shellfish;
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 |
|---|---|---|
| Capsules containing flax oilCapsules containing flax oil to provide 4 grams ALA per day for 4 weeks | Dietary supplement | Flax oil |
| Capsules containing DHA-enriched fish oilCapsules containing fish oil to provide 4 grams DHA per day and 0.8 grams EPA per day for 4 weeks | Dietary supplement | Fish oil |
Primary outcome
Plasma oxylipin concentrations over time
Time frame: Baseline, 3 days, 28 days
A fasting venous blood sample will be obtained from participants on Days 0, 3 and 28 of each Supplementation Phase for the assessment of plasma oxylipin profile.
9 secondary outcomes
Plasma fatty acid composition over time
Time frame: Baseline, 3 days, 28 days
Monocyte metabolism over time
Time frame: Baseline, 28 days
Monocyte fatty acid composition over time
Time frame: Baseline, 28 days
Peripheral blood mononuclear cell (PBMC) oxylipin and cytokine production over time
Time frame: Baseline, 3 days, 28 days
Plasma adiponectin concentrations over time
Time frame: Baseline, 3 days, 28 days
Vascular function changes over time
Time frame: Baseline, 28 days
Plasma lipid profile, alanine aminotransferase (ALT), aspartate aminotransferase (AST), and creatinine over time
Time frame: Baseline, 3 days, 28 days
Vaginal fluid oxylipin profile over time
Time frame: Baseline, 28 days
Vaginal fluid immune cell composition and function over time
Time frame: Baseline, 28 days
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 2 Jul 2021.
- Derived from this study: PubMed 34293124Pauls SD, Rodway LR, Sidhu KK, Winter T, Sidhu N, Aukema HM, Zahradka P, Taylor CG. Oils Rich in alpha-Linolenic Acid or Docosahexaenoic Acid Have Distinct Effects on Plasma Oxylipin and Adiponectin Concentrations and on Monocyte Bioenergetics in Women with Obesity. J Nutr. 2021 Oct 1;151(10):3053-3066. doi: 10.1093/jn/nxab235.
- Individual participant dataSharing planned: No
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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.
Carla G Taylor, PhD principal investigator
St Boniface Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capsules containing flax oil and Capsules containing DHA-enriched fish oil in people with Obesity and Inflammation, run by University of Manitoba at 1 site in Canada.
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 11 inclusion and 11 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 2 Jul 2021. 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 Canada. 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?
Plasma oxylipin concentrations over time (time frame: Baseline, 3 days, 28 days). 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 NCT03583281, which also lists 1 linked publication.
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 2 Jul 2021.