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

NCT03583281 | Completed

• 1 other identifier: H18926
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Inflammation

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 3 days, 28 days

Secondary Outcomes (9)

• Plasma fatty acid composition over time

  Baseline, 3 days, 28 days

• Monocyte metabolism over time

  Baseline, 28 days

• Monocyte fatty acid composition over time

  Baseline, 28 days

• Peripheral blood mononuclear cell (PBMC) oxylipin and cytokine production over time

  Baseline, 3 days, 28 days

• Plasma adiponectin concentrations over time

  Baseline, 3 days, 28 days

Study Arms (2)

Flax oil

ACTIVE COMPARATOR

Participants will consume capsules containing flax oil (4 grams alpha-linolenic acid \[ALA\] per day) for 4 weeks

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

Dietary Supplement: Capsules containing DHA-enriched fish oil

Interventions

Capsules containing flax oil DIETARY_SUPPLEMENT

Capsules containing flax oil to provide 4 grams ALA per day for 4 weeks

Flax oil

Capsules containing DHA-enriched fish oil DIETARY_SUPPLEMENT

Capsules containing fish oil to provide 4 grams DHA per day and 0.8 grams EPA per day for 4 weeks

Fish oil

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• University of Manitoba: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

I.H. Asper Clinical Research Institute

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Related Publications (1)

• 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.

  PMID: 34293124 DERIVED

MeSH Terms

Conditions

Obesity; Inflammation

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Carla G Taylor, PhD

  St Boniface Research Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blinded
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Obese females

Study Record Dates

• First Submitted: June 15, 2018
• First Posted: July 11, 2018
• Study Start: June 1, 2018
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2021
• Last Updated: July 2, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)