Omega MonoPure® DHA EC (30 Softgels)

Scientific Information/Data

Discussion
The two most well-researched omega-3 polyunsaturated fatty acids (PUFAs) are
docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA). DHA is an essential
structural component of the central nervous system, and EPA plays a role in
supporting healthy cardiac and circulatory systems. Omega MonoPure DHA EC
features MaxSimil DHA. This particular form of the highly absorbable, patented
MaxSimil monoglyceride fish oil contains 1,350 mg of concentrated DHA and
236 mg of EPA.*
Absorption
Studies conducted by the manufacturer of MaxSimil provide promising results
suggesting better absorption than other fish oils. An unpublished, double-blind,
crossover, pharmacokinetic study was performed in healthy overnight-fasted
male and female subjects (N = 20) ages 19 to 60. Each subject was administered
a single dose of six softgels (containing ~2000 mg EPA and ~1500 mg DHA) of
either ethyl ester (EE) fish oil or MaxSimil. Compared to the EE form, MaxSimil
EPA and DHA reached a peak concentration more than three times higher than
that reached by EE fish oil. Moreover, MaxSimil not only reached maximum
concentration faster but also maintained plasma levels longer. Additional peerreviewed research related to bioavailability is warranted.*[1-3]

Early Brain and Eye Development
Polyunsaturated fatty acids (PUFAs) play a critical role in the normal development
of the eye, brain, and central nervous system, and DHA is the most abundant
structural fatty acid in these tissues. DHA is transferred directly from mother
to fetus during pregnancy, especially during the last trimester, and is available
to infants through breast milk. This fatty acid plays a vital role in both prenatal
and postnatal brain development. Based on recommendations made by various
organizations, pregnant and nursing women should consume 100-300 mg of DHA
daily to meet basic fetal and infant needs.*[4,5]
Research indicates that DHA-supplemented and breastfed infants score significantly
better on mental and psychomotor development tests and that PUFAs may support
normal activity levels and learning capacity during preschool years.[4,6] A study of
infants (N = 229) enrolled in three randomized controlled trials suggested that a
dose of 0.36% of total fatty acids as DHA (a concentration representative of human
breast milk) contributed to favorable problem-solving performance, a parameter
found to correlate with later IQ and vocabulary development.[7] However, the
outcome of a systematic review and meta-analysis showed that although omega-3
supplementation does appear to improve childhood psychomotor and visual
development, more studies are needed to confirm these conclusions and to explore
the significance of IQ later in childhood.*[8]
DHA has also been researched for its role in developing and maintaining eye health
and function during early life. A randomized trial of healthy formula-fed infants
(N = 244) suggested that infants who were not given DHA had poorer visual acuity
than those who were supplemented with DHA amounting to 0.32% of total fatty
acids.[9] Optimal retinal and visual cortex maturation was understood to depend
upon dietary DHA during development, and visual acuity and mental development
were “seemingly improved by extra DHA.”*[6]

Nervous System, Brain, Eye, and Cell Membrane Function
Functioning via cell membranes and anchored by phospholipid molecules, DHA
helps to optimize signal transmission in the tissues of the brain, eyes, and the
overall nervous system.[10] Levels of this fatty acid decline with aging. DHA
supplementation may play a role in maintaining myelin and neuronal health,
supporting healthy eicosanoid metabolism in the brain, and exerting pleiotropic
effects to support healthy metabolism and aging throughout the lifespan.*[6,11,12]
A study of healthy community volunteers (N = 280), ages 35-54, showed that
higher DHA levels were significantly associated with performance improvement
in the areas of nonverbal reasoning, mental flexibility, working memory, and
vocabulary.[13] Other research has focused on neuroprotectin D1 (NPD1), an
important mediator derived from DHA through the action of 15-lipoxygenase-1.
This mediator appears to have a positive effect on neurotrophic cell signaling,
normal cell-life cycles, beta-amyloid neurobiology, and prostaglandin formation.
A systematic review and meta-analysis suggested that omega-3 supplements
play a role in improving cognitive development in infants. Although the research
summarized in those studies indicated a functional role of DHA in brain health and
an effect on attention domain, additional research is needed to further define DHA’s
role in cognitive function for groups other than infants.*[14,15]
DHA is also required for the functional integrity of retinal pigment epithelium (RPE) cells
and may play an ongoing role in eye health and function throughout life.[10,16] Studies
on human RPE cells suggest that NPD1 orchestrates cell-protective mechanisms
(including inhibition of caspase-3 activation and COX-2 expression) and thus promotes
a healthy response after cellular insult.*[16,17]

Eicosanoid Metabolism, Heart Health, and Immune Health
In addition to the functional effects discussed above, research has established
that omega-3 fatty acids antagonize arachidonic acid-induced eicosanoid
formation. They also help generate resolvins and protectins known as specialized
pro-resolving mediators (SPMs)—EPA and DHA metabolites that are naturally
produced in vivo through enzymatic conversion of EPA and DHA—to promote
a healthy response to the arachidonic acid cascade. Omega-3s have also been widely researched for their promotion of cardiovascular health, including
maintaining healthy lipid levels already within the normal range and supporting normal
resistance to oxidative stress.[10] Although not excluding similar benefits of EPA and
docosapentaenoic acid (DPA), DHA may have a direct or indirect benefit of keeping
the heart rhythm healthy and consistent. In multivariable-adjusted cross-sectional
analyses among older adults (N =~3000), plasma phospholipid DHA—but not EPA or
DPA—was inversely associated with resting heart rate and a trend toward lower blood
pressure (BP).[18] In one short trial, DHA reduced 24-hour ambulatory BP and heart
rate[19]; in another small trial (n = 59), the effect was not seen. Researchers speculated
that statistical power may have been limited by the size of the latter study.[20] This may
have been the case since in another, larger study (N = 224) in healthy men receiving
4 g/day each of EPA and DHA, lower heart rate and blood pressure was achieved. In
this study, plasma phospholipid analysis revealed that only DHA was responsible for
lowering heart rate.[21] Additionally, due to the preponderance of findings that EPA and
DHA can help moderate blood pressure, the FDA has approved a qualified health claim
with regard to this function.[22] Specifically for Omega MonoPure DHA EC: Research
shows that consuming EPA and DHA combined may be beneficial for moderating
blood pressure, a risk factor for CHD (coronary heart disease). However, the FDA has
concluded that the evidence is inconsistent and inconclusive. One serving (2 softgels)
of Omega MonoPure DHA EC provides 1.58 grams of EPA and DHA.*
Omega-3 fatty acids may also have immunomodulatory effects.[10] It has been
suggested in several human studies that supplementing with a DHA-rich oil appears
to decrease the activation of T lymphocytes and mononuclear cells and decrease
levels of inflammatory mediators.[23,24] The immune-altering effects may be due to
the composition of the cell membrane as well as to the activity of the DHA-derived
resolvins.*[25]

References

1. Unpublished, internal data. Ingenutra.
2. Fortin S, inventor; Centre de Recherche sur les Biotechnologies Marines, assignee.
Compositions comprising polyunsaturated fatty acid monoglycerides or derivatives
thereof and uses thereof. US patent 8,198,324. June 12, 2012.
3. Brunet S, Chamoun R, Fortin S, et al. MaxSimil®: A novel, patented natural platform for
enhanced absorption of omega-3s. Single dose, double-blind, 2-way crossover pilot
pharmacokinetic study on healthy subjects under normal diet. Sherbrooke (Québec),
Canada: Ingenutra; 2018. [Unpublished]
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20. Woodman RJ, Mori TA, Burke V, et al. Effects of purified eicosapentaenoic and
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Center for Food Safety and Applied Nutrition Constituent Update, US Food and Drug
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*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.