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Trial record 22 of 34 for:    alpha | linolenic acid

Effects of Dietary Fatty Acids on Octadecanoid Production and Biological Actions in Obesity-induced Inflammation (OXBIO)

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ClinicalTrials.gov Identifier: NCT03583281
Recruitment Status : Recruiting
First Posted : July 11, 2018
Last Update Posted : August 29, 2019
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University of Manitoba

Brief 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 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.

Condition or disease Intervention/treatment Phase
Obesity Inflammation Dietary Supplement: Capsules containing flax oil Dietary Supplement: Capsules containing DHA-enriched fish oil Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Obese females
Masking: Double (Participant, Investigator)
Masking Description: Double-blinded
Primary Purpose: Treatment
Official Title: Effects of Dietary Fatty Acids on Octadecanoid Production and Biological Actions in Obesity-induced Inflammation: Implications for Dietary Requirements
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Fish oil

Arm Intervention/treatment
Active Comparator: Flax oil
Participants will consume capsules containing flax oil (4 grams alpha-linolenic acid [ALA] per day) for 4 weeks
Dietary Supplement: Capsules containing flax oil
Capsules containing flax oil to provide 4 grams ALA per day for 4 weeks

Active Comparator: Fish oil
Participants will consume capsules containing DHA-enriched fish oil (4 grams DHA per day + 0.8 grams EPA per day) for 4 weeks
Dietary Supplement: Capsules containing DHA-enriched fish oil
Capsules containing fish oil to provide 4 grams DHA per day and 0.8 grams EPA per day for 4 weeks




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Plasma fatty acid composition 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 fatty acid composition.

  2. Monocyte metabolism over time [ Time Frame: Baseline, 28 days ]
    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.

  3. Monocyte fatty acid composition over time [ Time Frame: Baseline, 28 days ]
    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.

  4. Peripheral blood mononuclear cell (PBMC) oxylipin and cytokine production 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 Changes for isolation of PBMCs and assessment of oxylipin and cytokine production ex vivo

  5. Plasma adiponectin 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 adiponectin, an anti-inflammatory adipokine and marker of adipocyte dysfunction.

  6. Vascular function changes over time [ Time Frame: Baseline, 28 days ]
    Assessment of of vascular function using pulse wave velocity determined at Day 0 and 28 of each Supplementation Phase.

  7. Plasma lipid profile, alanine aminotransferase (ALT), aspartate aminotransferase (AST), and creatinine 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 lipid profile, ALT, AST and creatinine

  8. Vaginal fluid oxylipin profile over time [ Time Frame: Baseline, 28 days ]
    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.

  9. Vaginal fluid immune cell composition and function over time [ Time Frame: Baseline, 28 days ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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);
  2. 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× 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%;
  3. Blood pressure <160/100 (management with anti-hypertensive medications is acceptable);
  4. 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;
  5. Stable regime if taking vitamin and mineral/dietary/herbal supplements for the past 1 month and while participating in the study;
  6. Willing to maintain a stable level of activity while participating in the study;
  7. 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;
  8. Females must have normal menses and can be on birth control;
  9. 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;
  10. Willing to comply with the protocol requirements and procedures;
  11. Willing to provide informed consent.

Exclusion Criteria:

  1. 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;
  2. Taking medications for inflammation, pain or arthritis (e.g. 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;
  3. 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;
  4. 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;
  5. 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;
  6. Cigarette/cigar smoking or use of tobacco products within the past 12 months or during the study;
  7. Body weight has not been stable (plus or minus 3 kg) over the past 6 months;
  8. 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;
  9. Current (within the past 30 days) bacterial, viral or fungal infection;
  10. Unable to obtain blood sample at the screening, week 0 visit, or two consecutive study visits;
  11. Donated blood or blood products (e.g. platelets) or had blood collected in the 2 months prior to participation the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03583281


Contacts
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Contact: Carla G Taylor, PhD 204-258-1361 ctaylor@sbrc.ca
Contact: Peter Zahradka, PhD 204-235-3507 pzahradka@sbrc.ca

Locations
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Canada, Manitoba
I.H. Asper Clinical Research Institute Recruiting
Winnipeg, Manitoba, Canada, R2H 2A6
Contact: Carla G Taylor, PhD    204-258-1361    ctaylor@sbrc.ca   
Contact: Peter Zahradka, PhD    204-235-3507    pzahradka@sbrc.ca   
Principal Investigator: Carla G Taylor, PhD         
Sub-Investigator: Peter Zahradka, PhD         
Sub-Investigator: Harold M Aukema, PhD         
Sub-Investigator: Ruey-Chyi Su, PhD         
Sponsors and Collaborators
University of Manitoba
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Carla G Taylor, PhD St Boniface Research Centre

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Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT03583281     History of Changes
Other Study ID Numbers: H18926
First Posted: July 11, 2018    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Inflammation
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Pathologic Processes