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CLINICAL
ABSTRACT
Most
people do not eat enough fruits and vegetables and thus have less than optimal
levels of the vitamins, minerals and phytochemicals that have been associated
with healthy longevity.1–2 Because of this, medical
authorities recommend that all healthy adults consume a daily serving of
a multivitamin.3–6 However, more research is needed
to verify whether findings from test tube or population studies also apply
to people actually consuming a given multisupplement as intended - information
that can only be gathered by means of clinical trials.7
The challenge of clinical research on dietary supplements is that there's
no disease to treat, cure or prevent: How can one hope to find an improvement
if everybody's already healthy to begin with? But health now, of course,
doesn't necessarily reflect health in the future. Between any two people
of apparently equivalent good health, there may be an unsuspected difference
in risk factors.
With this background, the DOUBLE X™ 2005 reformulation
study was designed to test the benefits of consuming the recommended daily
serving of DOUBLE X™ on two levels: first,
by analysing the levels in the bloodstream of the health promoting nutrients
contained in DOUBLE X™ ; second, by analysing
the levels of selected risk factors.
For this Independent Review Board-Approved Study, 120 healthy men and women
were recruited, gave their written informed consent to participate in the
clinical trial, and had a medical exam by the physician Principal Investigator.
All subjects then gave blood samples before and after consuming either
DOUBLE X™ or placebo (three tablets, twice a day) for six weeks.
At week six, these samples were analysed for nutrients and risk factors.
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In the
realm of nutrient levels, as expected, plasma levels of vitamins B6, B12,
and folate increased significantly in the DOUBLE X™
group but showed no change in the placebo group. These three nutrients are
important factors in the recycling of homocysteine, a harmful by-product
of protein metabolism.8-10
Beta-carotene, which can be converted to vitamin A in the body,11
and vitamin E, another important antioxidant,12
were both also significantly increased in the DOUBLE
X™ group but not in the placebo group. In the realm of risk
factors, homocysteine reduced to a large extent in the DOUBLE
X™ group relative to the placebo group. Homocysteine is the
by-product of protein metabolism via methionine; it is known to induce DNA
strand breakage, oxidative stress, and apoptosis (cell death). Insufficient
recycling of homocysteine into cysteine by B6 or back into methionine by
folic acid and B6 leads to elevated plasma homocysteine levels and increased
risk for age-related health issues.
Last in this list of positive outcomes from this study, but perhaps first
in importance, the Micronucleus Assay, a measure of DNA damage in dividing
cells, showed significantly reduced DNA damage in subjects who had consumed
DOUBLE X™ for six weeks, but no significant
change in subjects who had consumed placebo. DNA damage, as indicated by
the Micronucleus Assay, is believed to be a sensitive early marker of risk
of chronic health conditions.
This controlled clinical study thus demonstrates benefi cial nutrients in
DOUBLE X™ are absorbed by the body, and
that functional benefits - in lowered homocysteine levels, and protected
DNA - are detectable in healthy adults, which suggests that DOUBLE
X™ helps maintain healthy ageing.
To learn more about this and other research, visit us at
www.nutrilite.com
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