explanation by Rik J. Deitsch on the Results
Presented on Cleveland Clinic Trial on BiosLife2®
Click here to download this
press release (.PDF)
An Over-the-Counter LDL-Lowering Product
Dennis L. Sprecher MD,1 Gregory L. Pearce,1 Anita M.Boddie RD, PhD,2 Nader
Fotouhi, PhD,2 Vicki Horiatis RN1
The Cleveland Clinic Foundation, Cleveland, Ohio
Rexall Sundown, Inc., Boca Raton, Florida
Patients (n=119) were randomized to either a fiber-blend treatment or placebo
99 participants (50 treatment, 49 placebo) completing the study. Fasting lipid
(including ApoB) and homocysteine concentrations were obtained at weeks 4 and 8.
Between group (Wilcoxon rank-sums test) and within group (paired t-tests)
were used to evaluate treatment effect.
A commonly used 90% soluble, fiber-blend product (Bios Life 2®) has not been
evaluated for lipid altering effect. Few data are available to describe the
fiber on serum ApoB levels. Further, as a fiber-vitamin combination agent, the
claim of folate/B6 benefit in the setting of fiber intake has not been examined.
Subjects in both groups showed similar baseline LDL levels (159mg/dl vs.
The treatment group showed a 7.9% +/- 11.0 reduction (p<0.001) over 8 weeks.
Placebo patients showed a slight increase in LDL over the same period (+2.4% +/-
11.7, p=0.16), for a 10.3% difference between groups (p<0.001). ApoB measured in
a subset (n=53) revealed a 20% reduction with treatment (p=0.004). Treatment
showed a reduction in homocysteine (9.8 mg/dl to 8.7 mg/dl, p=0.02), while
neither TG (p=0.95) nor HDL-c (p=0.54) changed.
Significant LDL- and ApoB-lowering effects are demonstrated. No adverse effects
triglyceride or HDL-c levels were noted, and folate/B vitamin-derived benefits
towards homocysteine reduction were preserved. This combination product could be
used to reduce the need for concomitant lipid lowering prescription therapy, as
as for advancing self-styled primary prevention strategies.
Bios Life 2® - Abstract explanation
The abstract explains the results of the controlled, randomized, double-blind
clinical trial on Bios Life 2®
that was accomplished by the Cleveland Clinic.
The abstract states that 119 patients were randomized for the trial. All of the
patients were required to eat.
Rik J. Deitsch
Before medications are approved for widespread use, they are typically tested in
a controlled clinical trial.
Controlled trials are considered necessary to show that a medication's effects
are not subjective (relying on the
patient's or physician's interpretation). Otherwise, a researcher might (perhaps
unintentionally) test the medication
only in patients who already show signs of responding well to treatment. Or a
patient, knowing that
the medication is supposed to have a specific effect, could experience that
effect due to some other factor but
attribute the relief solely to the new medication.
The preferred way to avoid subjectivity is to do a controlled study. In a
controlled study or trial, patients
in one group receive the investigational product while patients in another
group—the control group—receive
a placebo (an inactive substance that is indistinguishable from the
investigational product). This arrangement
allows researchers to compare the health of the group receiving the new product
with the control group. If the
group receiving the new product shows clear and measurable improvements in
symptoms, but the control
group does not, researchers can reasonably conclude that the new product was
responsible for improving the
health of the treatment group.
To ensure that comparisons between a treatment group and control group are
researchers select people for both groups who are similar in age, weight, health
status, and other factors. The
most common way to accomplish this is through randomization. Researchers first
gather a group of people
with similar characteristics. They then randomly assign each person to either
the treatment group or the control
group. This ensures that certain patients aren't "hand picked" for a group
because of their characteristics.
The final step in ensuring that a research study is objective is blinding.
Blinding is used to eliminate the
effects of personal beliefs and biases (on the part of both researchers and
patients). In a single-blind study, the
patients do not know whether they are in the treatment group or the control
group, but the researchers do
know. In a double-blind study, no one involved—not the patients, researchers, or
data analysts—know which
patients are receiving the new product and which are not.
A controlled, randomized, double-blind clinical trial therefore produces the
most objective and scientifithe
same low-fat diet for the six weeks leading up to the trial and then continue on
a controlled diet throughout
the trial. This isolated the variable. In other words, the patients' diet would
not have been the cause of any
difference in serum cholesterol as all of the patients had been following the
Ninety-nine patients completed the trial (50 on the Bios Life 2® and 49 on the
placebo). Blood work was
done at the fourth and the eighth week of the trial. The values obtained from
the blood work were then statistically
analyzed. Accepted methods of mathematical analysis can determine whether a
difference in treatment
outcomes is statistically significant. A statistically significant difference
means that the result is very unlikely to
be due to chance alone. Researchers represent the degree of certainty in a
result as what is called a "p value."
A p value of less than 0.05 indicates that the results of the study are
statistically accurate and did not occur by
chance. Achieving a significant p value is heavily dependent on the number of
people in the groups that are
LDL is "Low Density Lipoprotein." A lipoprotein substance (combination of a fat
and a protein) acts as
a carrier for cholesterol and fats in the bloodstream. High levels of low
density lipoprotein (LDL) are considered
a positive risk factor for the development of coronary artery disease. Less than
130 mg/dl is desirable, 130
to 159 mg/dl is borderline high, over 160 is considered high. The results showed
that there was an average
difference in LDL levels of 10.3% between the groups. This is statistically
significant (p<0.001) and shows
the difference being solely attributable to the Bios Life 2®.
ApoB is "Apolipoprotein B." Apolipoproteins are proteins on the surface of the
lipoprotein complex that
bind to specific enzymes or that transport proteins on the cell membranes; this
directs the lipoprotein to the
proper site of metabolism. ApoB is in LDL (low density lipoprotein). Unlike HDL
and LDL measurements
(which are indirect), apolipoprotein levels can be measured directly. Knowing a
patient's ApoB levels may give
a much more accurate picture of his or her health, including the risk for heart
disease. The results showed a
20% reduction in ApoB with treatment. This value showed statistical significance
Homocysteine is an amino acid produced by the body by altering another amino
acid, methionine. In a
healthy system, homocysteine is usually converted into other amino acids.
Elevated levels of homocysteine in
the blood appear to make for an elevated risk of cardiovascular (heart and
vessel) disease. Homocysteine can
damage blood vessels in several ways. It injures the cells that line arteries
and stimulates the growth of smooth
muscle cells. Homocysteine can also disrupt normal blood clotting mechanisms,
increasing the risk of clots that
can bring on a heart attack or stroke. The results showed an 11.2% reduction in
homocysteine levels in the
patients taking Bios Life 2®. This value has lower statistical significance
(p=0.02), and the changes cannot be
wholly attributed to the product.
TG represents "triglycerides." These are the storage units for fat in the body.
Elevations of the triglyceride
level (particularly in association with elevated cholesterol) have been
correlated with the development of atherosclerosis,
an underlying cause of heart disease and stroke. The results showed a reduction
that was not statistically significant (p=0.95). As such, the article will
represent that "triglycerides were
unchanged." Even that is important as many other methods for lowering serum
cholesterol may increase
HDL is "High Density Lipoprotein." Raised high density lipoprotein levels have
been correlated with a
lower risk for heart disease. Less than 35 mg/dl is considered a positive risk
factor for coronary artery disease,
while over 60 mg/dl is considered a negative risk factor (reduces your risk of
heart disease). The results showed
an increase in HDL that was not statistically significant (p=0.54). As such, the
article will represent that "HDL
levels were unchanged." Again, even that is important as many other methods for
lowering serum cholesterol
may decrease HDL levels.
The most encouraging part of the abstract lies in the conclusion. Almost every
study that is completed on
complementary therapies states an ambiguity in the conclusion. Usually something
to the effect of "these
results suggest that more study is warranted." Dr. Sprecher never states
anything like that. His simple conclusion
is that Bios Life 2® was effective in the clinical trial. He even states that
Bios Life 2® should be used for
primary prevention of hypercholestremia.
website at www.BL2.info
Click here to download this
press release (.PDF)