Cardiovascular Disease, Inflammation Clinical Trial
— n3Official title:
Impact of EPA and DHA Supplementation on Plasma Biomarkers of Inflammation in Men and Women With Metabolic Syndrome
| Verified date | February 2018 |
| Source | Laval University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Subclinical inflammation is now indisputably recognized as a key etiological factor in the
development of atherosclerosis and subsequent cardiovascular disease. Obesity and related
dysmetabolic states including metabolic syndrome (MetS) are highly prevalent causes of
subclinical inflammation. Obesity and MetS are both diet and lifestyle-related and there is a
growing body of literature suggesting that specific nutrients, such as long chain omega-3
polyunsaturated fatty acids (LCn-3PUFA), may attenuate the pro-inflammatory state associated
with these conditions. However, careful review of existing literature on this topic reveals
important gaps in knowledge, the purported anti-inflammatory effects of LCn-3PUFA even being
questioned by many. Significant confounding attributable to study design, sample size and
biomarker selection may be responsible in part for inconsistencies in the literature on
LCn-3PUFA and inflammation. We also found that evidence available to date (for and against)
is based primarily on secondary analyses, as most of the studies published were not primarily
designed to investigate inflammation as a primary outcome. It remains unclear whether the
different LCn-3PUFA, primarily docosahexaenoic acid (DHA, 22:6n-3) and eicosapentaenoic acid
(EPA, 20:5n-3), have similar effects on pro-inflammatory processes as almost all studies were
undertaken using a mix of LCn-3PUFA. Whether efficacy of EPA and DHA is influenced by
sex/gender is also unknown. Finally, a better understanding of the systemic and
tissue-specific mechanisms underlying the anticipated anti-inflammatory effects of different
LCn-3PUFA in MetS would also be of great value. Addressing these gaps has important public
health implications, considering that LCn-3PUFA supplements are broadly and indiscriminately
recommended for the prevention of cardiovascular disease.
The overarching objective of the proposed research is to compare the anti-inflammatory
effects of EPA and DHA in men and women with MetS.
| Status | Completed |
| Enrollment | 170 |
| Est. completion date | December 2017 |
| Est. primary completion date | July 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility |
Inclusion Criteria: - Men and women aged between 18 and 70 years with abdominal obesity as defined by the International Diabetes Federation criteria and a measure of plasma CRP >1 mg/L - Stable body weight for at least 3 months prior to randomization. - Pre-menopausal women with regular menstrual cycle (25-35 days) Exclusion Criteria: - Plasma CRP > 10 mg/L at screening - Extreme dyslipidemias such as familial hypercholesterolemia - Previous history of cardiovascular disease (coronary heart disease, cerebrovascular disease or peripheral arterial disease) - Subjects taking medications known to affect inflammation (e.g. steroids, binging alcohol) - Subjects taking LCn-3PUFA supplements within 2 months of study onset. |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Institute of Nutrition and Functional Foods (INAF), Laval University | Quebec |
| Lead Sponsor | Collaborator |
|---|---|
| Laval University | Canadian Institutes of Health Research (CIHR) |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in plasma biomarkers of inflammation (CRP, Interleukin (IL)-6, IL-18 and Tumor necrosis factor-a) | Change between treatments based on post-treatment values, adjusting for treatment-specific baseline values | At the beginning and the end of each 10-week period | |
| Secondary | Change in lipid concentrations (LDL-C, HDL-C, TG) | Change between treatments based on post-treatment values, adjusting for treatment-specific baseline values | At the beginning and the end of each 10-week period | |
| Secondary | Change in blood pressure | Change between treatments based on post-treatment values, adjusting for treatment-specific baseline values | At the beginning and the end of each 10-week period | |
| Secondary | Change in endogenous production and clearance rate of CRP (in a subsample of the entire study population) | Change between treatments based on post-treatment values | At the end of the three 10-week periods | |
| Secondary | Change in expression of inflammation genes in peripheral blood cells (in a subsample of the entire study population) | Change between treatments based on post-treatment values | At the end of the three 10-week periods | |
| Secondary | Change in anthropometric measures (waist and hip circumference) | Change between treatments based on post-treatment values, adjusting for treatment-specific baseline values | At the beginning and the end of each 10-week period |