Download Effects of the Dietary Supplement, FOCUSfactor®, on Memory and

Effects of the Dietary Supplement,
FOCUSfactor®, on Memory and
Concentration
Bridgette Heiner
Biology 493
Dr. Gold and Dr. Day
04 June 2009
Abstract
In 1994, a United States law was passed that effectively deregulated the dietary supplement market and
removed most natural herbs, essential oils, enzymes and glandular products from government oversight. The
law requires that the product makes no specific claims to treat disease; accordingly, nearly any natural product
can be sold as a dietary supplement with no requirement for proof of efficacy (FDA 1995). Since 1994, the
market for dietary supplements has experienced dramatic growth; worldwide sales of dietary supplements were
approximately $53.4 billion in 2007 (Zambetti 2008). Among the most popular dietary supplements are those
that promise to enhance memory and improve concentration. FOCUSfactor® has become one of the leading
companies in the development of a memory enhancing supplement (MediZine 2009). The FOCUSfactor®
formulation includes a diverse mixture of ingredients but only a few have been shown to have a direct affect on
cognitive function (Levant 2006, Higdon et al. 2009, Durga et al. 2007, Wang et al. 2006). Docosahexaenoic
acid (DHA) has been shown to associate with phospholipids in the brain and retina and to play a crucial role in
neurological development (Blaylock 2008). Vitamins B6, B9 (folic acid) and B12 are involved in pathways
associated with brain function assisting in synthesis of important chemical components (Schaeffer et al. 1998,
Moretti et al. 2004). Huperzine A (HupA), an alkaloid, has been found to improve memory, cognitive skills, and
daily life abilities of Alzheimer’s disease patients (Wang et al. 2006).
While some research suggest a link between these individual constituents and various neurological and
cognitive functions, no published studies have specifically investigated the efficiency of FOCUSfactor® in
improving memory. The purpose of this research was to gauge the effects of FOCUSfactor® on memory
among college-aged young adults, 20-30, in a double-blind format. Validated memory exams (Poppenk 2007)
were scored and used to compare the significant difference of treatment and non-treatment exams. Data was
compared using ANOVA and Paired T-Tests. It was found that there was no significance within the placebo
group (P=0.38) nor within the FOCUSfactor® group (P=0.15) when comparing test 3 and test 4. If the placebo
group is compared to the FOCUSfactor® group there is a significant difference that should considered.
Statically FOCUSfactor® is significant compared to the placebo though not compared internally, due to the
difference in how test 1 was taken.
Introduction
Dietary supplements have been used medicinally and in various successful attempts to proactively
improve health, increase vitality, and improve the perceived quality of life. In 1994, a United States
law was passed that effectively deregulated the dietary supplement market and removed most natural
herbs, essential oils, enzymes, and glandular products from government oversight. The law requires
that the product makes no specific claims to treat disease. Nearly any natural product can be sold as a
dietary supplement with no requirement for proof of efficacy (FDA 1995). Since 1994, the market
for dietary supplements has experienced dramatic growth (Noonan and Noonan 2006) and by 2007
worldwide sales hit approximately $53.4 billion (Zambetti 2008).
Among the ever-growing market
are supplements promising to enhance memory and improve concentration. FOCUSfactor® has
become one of the leading companies in the development of a dietary supplement for improved
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memory and concentration (MediZine 2009). FOCUSfactor® is sold as a pill containing forty
different vitamins and minerals, including Docosahexaenoic acid (DHA), vitamin B6, vitamin B12,
folic acid, and huperzine A (Factor Nutrition Labs 2009, MediZine 2009).
Docosahexaenoic acid (DHA) is an omega-3 fatty acid which is naturally extracted from fatty fresh
water fish (Blaylock 2008) and some plants such as seaweed (UMMC 2008). Researchers suggest
that DHA associates with phospholipids in the brain and retina, playing a crucial role in neurological
and visual development in infants (Blaylock 2008, UMMC 2008).
Further research found
improvements of brain function in adults that take daily supplements (Blaylock 2008) and reduce the
effects of depression (Levant 2006).
Vitamin B6 (pyridoxal-5-phosphate) has been identified as a coenzyme for the synthesis of serotonin
from the amino acid, tryptophan in the brain (Schaeffer et al. 1998). A controlled study of 38 healthy
elderly men found that vitamin B6 supplementation improved memory, though not mental
performance (Higdon et al. 2009).
Vitamin B12 and Folic acid (Vitamin B9) are both required in the methylation of homocysteine, and
a deficiency of B9 and B12 leads to a build-up of homocysteine which has been linked with dementia
and Alzheimer’s disease (Moretti et al. 2004). Researchers have tied low levels of B9 and B12 to
depressive disorders and congenital defects in the enzymes involved in pathways associated with
brain function (Moretti et al. 2004). Another study performed by Durga et al. (2007) found that a
daily intake of 800 µg of folic acid for three years beneficially affected cognitive function, more
specifically memory and information processing.
Huperzine A (HupA) is an alkaloid isolated from Huperzia serata (Qian Ceng Ta), which has been
used in Chinese folk medicine for centuries in the treatment of contusions, strains, swelling, and
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schizophrenia (Zhang et al. 2008). Recent research has suggested that HupA improves memory,
cognitive skills and daily life abilities of Alzheimer’s disease patients (Wang et al. 2006).
The recommended daily amounts of folic acid, vitamin B12 and vitamin B6 are exceeded in the
recommended dosage of FOCUSfactor®.
While some research suggests a link between these
vitamins and cognitive functions, no published studies have specifically investigated the efficiency of
FOCUSfactor® in improving memory.
The purpose of this study was to gauge the effects of
FOCUSfactor® on memory among college-aged young adults in a double-blind format.
Methods
Twelve males and ten females, aged 20-30, were recruited from the BYU-Hawaii campus to
participate in a double-blind study.
A proposal was submitted and approved by BYU-Hawaii
Institutional Review Board (IRB). Volunteers were surveyed to determine current usage of dietary
supplements and asked to refrain from those until the end of the study. Each student was informed of
the risks and the possible benefits of FOCUSfactor
®
(Factor Nutrition Labs, LLC, Portland, ME)
before the first dose. The volunteers took one FOCUSfactor® pill orally every four hours throughout
the day, starting at 0730. The placebo consisted of HY-C pills (Solgar Vitamin and Herb, Leonia, NJ),
containing 20mg of calcium and 600mg vitamin C, per day. Placebo and treatment were administered
daily for 30 days, with dosage adherence and physical symptoms surveys administered weekly.
A validated memory test (Poppenk 2007) was administered to each volunteer day zero, fifteen, thirty,
and thirty-seven. Each memory test consisted of 25 phrases shown one at a time for five seconds
each. Exam one was administered slightly different then the following three, a list of 50 phrases, only
half being correct, was shown on the screen and it was required to write out the original 25 phrases.
Due to time conflicts, the method of testing was switched for the remainder of the study: after seeing
25 phrases a list of 50 phrases was handed to each participant, and the volunteers were required to
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circle as many of the original 25 phrases as they could recall. The results of all four exams were
compared for each individual participant and analyzed by ANOVA and a Paired T-Test.
Results & Conclusions
All validated memory tests were evaluated, counting each correctly circled or written phrase;
incorrect answers were not counted against the total score.
Placebo
Test 1
Test 2
Test 3
Test 4
2
22
23
23
19
17
21
22
24
24
20
22
25
21
24
23
18
24
23
17
25
19
20
15
12
26
13
18
23
20
6
8
19
21
23
1
9
23
23
21
15
18
22
21
23
22
24
24
24
25
11
13
20
17
18
Treatment
Test 1
Test 2
Test 3
Test 4
24
13
12
19
17
28
20
21
22
18
27
20
20
20
23
15
14
20
8
21
22
21
19
3
20
20
22
22
19
12
17
21
17
10
19
18
21
21
9
12
16
20
20
4
18
20
21
25
29
15
12
16
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Figure 1 The table above indicates the individual scores from each of the participants.
ANOVA was used to determine the significant difference between all four scores of each
individual. The results, when comparing FOCUSfactor® scores to the placebo scores, showed a
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significant difference in the FOCUSfactor® group (P=0.000) but no significant difference in the
placebo group (P=0.079). The data included two participants that completed treatment but did not
take all the exams, which should not affect the overall comparison of the two groups. This significant
difference showed that FOCUSfactor® was significant even with differences in the test taking
methods.
To clarify the results further, Paired T-Tests were completed comparing test one with test
three internally for each group. The Paired T-Test was taken twice to determine how the two
participants that did not complete the memory exams affected the data of the FOCUSfactor® group.
The fist Paired T-Test was compared including the blank memory test scores.
This gave the
following mean values for the FOCUSfactor® group: 15.5 and 19; P=0.32. The second Paired TTest removed the two participants completely to find the significant difference: μ1=16.7 and μ3=20.3;
P=0.01. Removing the two individuals gave a significant difference within the FOCUSfactor® group.
Using the same comparison of test one to test three for the placebo group gave the following data:
μ1=17 and μ3=21.4; P= 0.04. This indicates a significant difference within the placebo group. The
significant difference in the placebo group is assumed to be caused by the change in how memory test
one was conducted compared to how the last three memory tests were conducted. The determination
of treatment vs. non-treatment tests could also be compared by looking at test three with test four: the
peak of the treatment vs. the washout. This gave the following mean values for the FOCUSfactor®
group, comparing within the group itself: μ3=20.6 and μ4=19.0; P=0.15. With the following mean
values for the placebo group: μ3=21.4 and μ4=20.5; P=0.38. Using the last two test scores as a
comparison shows no significant difference for either group. Based on the data found, the results of
the study showed no significant difference in the memory tests for FOCUSfactor® when compared
internally but the results are significant when the two groups (FOCUSfactor® vs. placebo) are
compared.
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