Advances Volume 24 No.
5 Advances In Natural Therapy™
In Therapy® September/October 2007
The Effect of NeOpuntia®
on Blood Lipid Parameters—
Risk Factors for the Metabolic
Syndrome (Syndrome X)
Elodie Linarès, PhD
Catherine Thimonier, MSc
Michel Degre, MSc
BIO SERAE Laboratoires SA
Parc Technologique du Lauragais
Bram, France
ABSTRACT
Metabolic syndrome (syndrome X) causes millions of cardiovascular complications
and premature deaths every year. The aim of this study was to evaluate the effects
of NeOpuntia®, patented, dehydrated, Opuntia ficus-indica leaves, on blood lipid
parameters and metabolic syndrome. Opuntia ficus-indica leaves are traditionally
consumed as a vegetable. Participants in this monocentric, randomized, placebo-
controlled, double-blind, 6-wk study were 68 women, ages 20 to 55 y, with meta-
bolic syndrome and a body mass index between 25 and 40. Fifty-nine subjects
completed the study according to the study plan. All volunteers followed well-
balanced diets with controlled lipid input. NeOpuntia or placebo capsules were
taken at a dosage of 1.6 g per meal. All 5 syndrome X criteria were measured on
days 0, 14, and 42, including low-density lipoprotein cholesterol (LDL-C), high-
density lipoprotein cholesterol (HDL-C), and triglyceride levels. For the 42 females
above 45 y of age, we show a significant increase in HDL-C levels with NeOpuntia
and a tendency toward decreased triglyceride levels. At the same time, there was
a decrease in HDL-C levels with placebo. Overall, for the entire study population,
similar but less pronounced tendencies were demonstrated. Forty-two females tak-
ing NeOpuntia with no additional hypolipemic treatment, had a pronounced
reduction in LDL cholesterol, especially after day 14. At the study end, 39% of the
NeOpuntia group, but only 8% of the placebo group, were no longer diagnosed
with metabolic syndrome. Our results indicate an advantage of using NeOpuntia
in dietary supplements and functional foods because of improvement of blood
lipid parameters associated with cardiovascular risks.
Keywords: cholesterol; NeOpuntia®; HDL-C; metabolic syndrome;
syndrome X; cladodes; nopal; Opuntia ficus-indica
©
2007 Health Communications Inc Address correspondence to
Transmission and reproduction of this material in whole Mrs Elodie Linarès
or part without prior written approval are prohibited. BIO SERAE Laboratoires SA,
Parc Technologique du Lauragais
1192 1 av. de la Preuilhe
11150 BRAM France
Email: [Link]@[Link] 1115
INTRODUCTION
Traditionally, the leaves and fruit of the cactus Opuntia ficus-indica (also called
nopal) have been used for medicinal and cosmetic purposes.1 Historically, the leaves
of this cactus, called cladodes, have been consumed as a vegetable throughout Latin
America and Southern Europe.2,3 Wiese et al observed a reduction in alcohol hang-
over symptoms related to the consumption of an Opuntia ficus-indica extract, and
attributed this effect to the antioxidative properties of the plant.4
The consumption of fresh or dehydrated leaves of Opuntia ficus-indica has been
studied in animal models, in order to evaluate the effects on lipid metabolism. One of
the first studies was performed on laboratory rats, showing that consumption of nopal
induced a decrease in low-density lipoprotein cholesterol (LDL-C) levels of 34%, with-
out affecting high-density lipoprotein cholesterol (HDL-C) levels.5 A more recent
study demonstrated a significant reduction in cholesterol, LDL-C, and triglyceride
plasma levels in hypercholesterolemic rats following daily administration of lyophi-
lized leaves of Opuntia ficus-indica.6
A recent review summarizes the current knowledge of the chemical composition
of Opuntia cacti in relation to its use as a health food.7
NeOpuntia® is defined as leaves of the prickly pear cactus (Opuntia ficus-indica),
dehydrated according to a patented process (PCT/ FR 02/ 0125). After several stud-
ies on in vitro models, to examine the interaction of NeOpuntia with fats from food,
a preclinical study was conducted to evaluate the capacity of NeOpuntia to reduce
fat absorption.
The metabolic syndrome (syndrome X) is considered to be the sum of all non-
pathologic disorders that constitute cardiovascular risk factors. The clinical definition
of metabolic syndrome, as defined by the International Diabetes Federation,8 is based
on 5 parameters: fasting glucose (≥1 g/L), abdominal obesity (waist circumference
≥80 cm for women and ≥94 cm for men), blood pressure (≥130/85 mm Hg), blood
triglycerides (≥1.5 g/L), HDL-C (≤0.50 g/L for women and ≤0.40 g/L for men).
Abdominal obesity is a mandatory criterion of the metabolic syndrome. The presence
of 3 out of the 5 parameters is sufficient for a positive diagnosis. The objective of the
present clinical study was to examine the ability of NeOpuntia to regulate the 5 para-
meters associated with metabolic syndrome.
SUBJECTS AND METHODS
This was a monocentric, randomized, double-blind, placebo-controlled study in
a parallel-group design. It was conducted in France, between May and June 2006, by
Proclaim (Parc d’affaires de la Bretèche, 35760 Saint-Gregoire, France).
Subjects
The inclusion criteria were females, aged 20 to 55 y, with a body mass index (BMI)
between 25 and 40, diagnosed with metabolic syndrome, as defined by the Interna-
tional Diabetes Federation in 2005.8
From 88 preselected volunteers, 68 were included in this study (intention-to-treat
[ITT]-population), as the others did not meet the inclusion criteria. Fifty-nine volun-
E. Linarès, et al
NeOpuntia and Blood Lipid Parameters
1116
teers completed the study according to the study plan, the rest dropped out or missed
examinations, mainly due to personal reasons. The data evaluation is based on the ITT
population. The age distribution was as follows: 10.29% <35, 27.94% 35 to 45, 41.18%
45 to 55, and 20.59% >55. All volunteers were informed of the trial duration and goal,
and gave their voluntary consent to participate.
Study Material
For 6 wk, 35 women consumed 1.6 g of NeOpuntia capsules 1/2 to 1 h after each
meal (3 times daily) with a glass of water. Thirty-three women took placebo capsules
in the same manner. During the study, it was recommended that volunteers follow
a balanced diet, with at least 30 min of physical activity per day. The balanced diet was
characterized by an average caloric input of 2000 kcal with an intake limitation of 38%
lipids, 17% protein, and 45% carbohydrates.
Data Analysis
Several blood lipid parameters were examined at the start of the study, as well as
on days 14 and 42 (D0, D14, D42), in particular, development of LDL-C, HDL-C,
triglycerides, and metabolic syndrome diagnosis. The development of these para-
meters was evaluated according to a variance analysis, to allow comparison of aver-
ages and to determine if differences in each group were statistically significant. The
intra-group developments were evaluated by a Student t test. Statistical significance
was defined as P<.05, and a significant tendency by a P value between .05 and .10.
RESULTS
A total of 68 subjects were included in this study, 59 of whom completed it accord-
ing to the study plan. The average age of the study participants was 47.3 ±10.1 y and
they presented the following profiles at the inclusion: glycemia of 1.06 g/L ± 0.37,
LDL-C of 1.42 g/L ± 0.47, HDL-C of 0.67 g/L ± 0.2, total cholesterol of 2.29 g/L ±
0.50, triglycerides of 1.11 g/L ± 0.71, and average waist circumference of 101.41 cm
± 13.37. Several of the volunteers fulfilled the inclusion criteria of metabolic syn-
drome with only 3 of the 5 syndrome parameters. A slight improvement could there-
fore result in a patient no longer being diagnosed with syndrome X.
Regardless of their group, 91% of the participants followed the dietary recom-
mendations and approximately 80% of the participants followed the physical activi-
ty recommendations. Approximately 10% of the participants had compliance
irregularities, 90% regularly took NeOpuntia or placebo. The relatively high compli-
ance can be explained with the thorough volunteer instruction and relatively high
volunteer motivation.
Safety
During the treatment, no severe adverse effects were observed with the ingested
dosage of NeOpuntia or placebo. Two cases of gastric disorder, resulting in nontol-
erance of the preparation, were reported after NeOpuntia intake; however, there
also were 2 reports of nontolerance in patients in the placebo group, 1 with abdom-
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Volume 24 No. 5, September/October 2007
1117
inal pain and flatulence, and the other, insomnia. Other even milder adverse events,
including digestive problems, constipation, etc, were described by 7 volunteers in
the NeOpuntia group and 5 patients in the placebo group.
Efficacy in the Total Population
LDL-C, HDL-C, total cholesterol, and triglyceride levels were measured at D0, D14,
and D42 (Table 1).
Table 1. Development of Blood Lipid Parameters in the Total Population
of Placebo and NeOpuntia Groups
Development From Development From
Day 0 to Day 14 Day 0 and Day 42
Placebo % P Value % P Value
LDL-C 6.6% 0.060 –9.2% 0.050
HDL-C –4.4% 0.346 –7.2% 0.137
Total cholesterol –4.7% 0.041 –7.0% 0.035
Triglycerides 1.6% 0.767 0.3% 0.963
Development From Development From
Day 0 to Day 14 Day 0 and Day 42
NeOpuntia % P Value % P Value
LDL-C –2.9% 0.673 –2.9% 0.429
HDL-C +4.3% 0.090 +3.2% 0.256
Total cholesterol –2.7% 0.156 –2.9% 0.082
Triglycerides –5.2% 0.388 –8.0% 0.435
Even in the placebo group, a decrease in LDL-C and total cholesterol levels was
observed. These changes could be attributed to the application of dietary advice
(balanced diet and physical activity); however, there was also a downward trend for
HDL-C levels in the placebo group, whereas with the consumption of NeOpuntia,
increased HDL-C levels were observed at D14 with a significant trend, which was
still visible at D42.
The triglyceride levels remained elevated in the placebo group, and decreased
slightly in the NeOpuntia group, without statistical significance.
We analyzed the number of study participants still classified as having metabolic
syndrome (a clustering of abnormalities including waist circumference, HDL-C, blood
triglycerides, fasting glucose, and blood pressure) during and at the end of the study.
E. Linarès, et al
NeOpuntia and Blood Lipid Parameters
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At the end of the study, 92% of participants in the placebo group still had metabolic
syndrome, whereas only 61% of the NeOpuntia group still had metabolic syndrome
(Table 2). According to the definition of metabolic syndrome from the International
Diabetes Federation,8 the waist circumference is a mandatory criterion. Consequently,
a person with a waist circumference lower than 80 cm is no longer considered to have
metabolic syndrome, independent of the other criteria. In the NeOpuntia group,
2 females were not considered to have metabolic syndrome because their waist
circumferences decreased below 80 cm. This phenomenon was not observed in the
placebo group.
Table 2. Percentage of Volunteers With Metabolic Syndrome at Days 0, 14, and 42
Development From Day 0 to Day 42
Day 0 Day 14 Day 42
Placebo group, % 100 76 92
NeOpuntia group, % 100 52 61
To determine the parameters responsible for release from the metabolic syn-
drome, we analyzed the number of participants still affected by a single metabolic
syndrome criterion (Table 3). In the NeOpuntia group, improved parameters were
HDL-C, triglycerides, blood pressure, and waist circumference. In the placebo
group, the principal parameter showing an improvement was blood pressure. These
results show that more criteria improved with NeOpuntia consumption than with
placebo consumption.
Table 3. Development of Volunteer Numbers for Each Parameter of Syndrome X
Placebo Group NeOpuntia group
(33 volunteers) (35 volunteers)
Metabolic Syndrome Criteria Inclusion Day 42 Inclusion Day 42
HDL-C ≤0.5 g/L 15 16 8 7
Triglycerides ≥1.49 g/L 9 8 6 4
Blood pressure ≥130/85 mm Hg 19 5 18 8
Fasting glucose ≥0.95 g/L 20 22 15 15
Waist circumference ≥80 cm 33 33 35 33
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Effect on LDL-C in the Subgroup Without Hypolipemic Treatment
In the total population, inclusion criteria integrated volunteers with hypolipemic
treatment who were randomized in both groups (placebo and NeOpuntia). In view
of the proven fat-binding capabilities of NeOpuntia9-11 and the comparatively indif-
ferent effect of NeOpuntia on LDL-C in both the NeOpuntia and placebo groups, we
further analyzed the data of a subgroup consisting of females not receiving addi-
tional hypolipemic treatment. Table 4 shows the effect of NeOpuntia consumption
on the blood lipid parameters in this subgroup. Although no effect was identified in
the total population, the consumption of NeOpuntia decreased the LDL-C level with
a significant trend, especially at day 14: the reduction in LDL-C level was 10% in the
NeOpuntia group but only 3% in the placebo group.
One of the aims of hypolipemic treatment is the regulation of LDL-C and total
cholesterol levels. Although no additional effect was observed with the consump-
tion of NeOpuntia in the total population, an analysis of the subgroup without
hypolipemic treatment showed an additional improvement in LDL-C levels in the
NeOpuntia group. This result is in accordance with other scientific studies performed
on laboratory rats.5,6
Table 4. Development of Blood Lipid Parameters in the Subgroup Without
Hypolipemic Treatment
Development From Development From
Day 0 to Day 14 Day 0 and Day 42
Placebo % P Value % P Value
LDL-C –3.00% 0.491 –5.40% 0.345
HDL-C –4.97% 0.746 –7.78% 0.694
Total cholesterol –2.40% 0.145 –3.37% 0.184
Triglycerides –3.49% 0.184 +2.18% 0.553
Development From Development From
Day 0 to Day 14 Day 0 and Day 42
NeOpuntia % P Value % P Value
LDL-C –10.00%1 0.063 –5.60% 0.197
HDL-C +0.90% 0.641 +1.31% 0.462
Total cholesterol –3.52% 0.086 –2.69% 0.108
Triglycerides –4.55% 0.464 –15.81% 0.330
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NeOpuntia and Blood Lipid Parameters
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Efficacy in Other Subgroups
In order to identify the populations with the highest sensitivity to NeOpuntia con-
sumption, we performed a statistical analysis on different subgroups. Table 5 presents
the development of lipid parameters for 4 subgroups, defined by a glycemia level
higher than 0.95 g/L, blood pressure higher than 130/85 mm Hg, total cholesterol
higher than 2.40 g/L, or females older than 45 y.
Table 5. Development of the Lipid Parameters in 3 Subgroups Defined by Glycemia,
Blood Pressure, or Age. Mean Development in the NeOpuntia Group
Versus the Placebo Group Between Days 0 and 42
LDL-C HDL-C Total Triglycerides
Subgroup NeOpuntia Placebo NeOpuntia Placebo NeOpuntia Placebo NeOpuntia Placebo
Total study NS +0.0217 –0.0470 NS NS
population +3.2% –7.2%
(N=68) P=.058
Glycemia NS +0.0429 –0.0837 NS NS
>0.95 g/L +6.5% –13%
(n=33) P=.055
Blood pressure –0.0917 –0.2861 +0.0211 –0.0972 –0.1239 –0.3644 NS
>130/85 mm Hg –6.9 –17.4% +2.9% –14.4% –5.6% –14.3%
P=.097 P=.066 P=.062
Total cholesterol NS +0.0544 –0.0133 NS NS
≥2.40 g/L +7.1% –1.9%
(n=24) P=.041
Age >45 y NS +0.0495 –0.0709 NS –0.1545 +0.0586
+7.1% –10.7% –13.9% +5.6%
P=.029 P=.103
NS=No significant difference between the NeOpuntia group and the placebo group.
P values are group difference P values.
According to the International Diabetes Federation 2005,8 for people older than
40 y, type 2 diabetes correlates with a high cardiovascular risk. For this reason, the
results obtained from the subgroup with glycemia higher than 0.95 g/L at the inclu-
sion (D0) are very interesting. Compared with placebo, NeOpuntia consumption
induced a highly significant tendency to increase HDL-C levels by 6.5%, whereas
a decrease of 13% was observed in the placebo subgroup.
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The volunteers who took NeOpuntia whose blood pressure was higher than
130/85 mm Hg, showed a tendency to have an increase in HDL-C comparable with
the complete study population (+2.9%). In addition, a decrease in LDL-C and total
cholesterol levels was observed with a significant trend (–6.9% and –5.6%, respective-
ly). Volunteers with blood pressure higher than 130/85 mm Hg who were taking
placebo had an even stronger decrease in their LDL-C and total cholesterol values
(–17.4% and –14.3%, respectively); however, their HDL-C also decreased (–14.4%).
The subgroup of 24 volunteers with total cholesterol higher than 2.40 g/L showed
a significant increase in HDL-C levels with NeOpuntia consumption in spite of the
rather small size of the subgroup.
Interestingly, NeOpuntia consumption had the most significant effect on mea-
sured blood parameters in people over the age of 45 y: The volunteers taking
NeOpuntia had a statistically significant beneficial development in their HDL-C lev-
els of +7.1%. At the same time, their triglyceride levels decreased with an almost sig-
nificant tendency.
We also examined the triglyceride >1.49 g/L (N=15), age >40 (N=53), IMC >28
(N=38), and waist circumference ≥60 cm subgroups. Except for the triglyceride sub-
group, there were also significant trends towards increased HDL-C with NeOpuntia
consumption versus placebo in these subgroups, whereas the other blood fat para-
meters showed no significant changes.
DISCUSSION AND CONCLUSIONS
This clinical study is one of the first to evaluate the physiological effects of Opuntia
ficus-indica in humans. Prior studies were generally carried out with animals. Only
1 pilot study was performed with Opuntia robusta on 24 human males.9
Increased HDL-C levels are closely associated with reduced cardiovascular risk.
According to the Lipid Research Clinics Coronary Primary Prevention Trial on
hypercholesterolemic men followed for 7 to 10 y, each 0.01 g/L increment in HDL-C
was associated with a 5.5% decrement in risk of “definitive” coronary heart dis-
ease.10 In the Framingham Heart Study, the associated decrease in cardiovascular
risk was 2% for men and 3% for women, and the epidemiological data generally
support an independent inverse association of HDL-C levels and cardiovascular dis-
eases, in which the coronary heart disease risk decreases by 2% to 3% for each 0.01 g/L
increment in HDL-C levels.11
An increase in HDL-C gives cardiovascular protection by supporting reverse cho-
lesterol transportation from atherosclerotic lesion macrophages to the liver, followed
by excretion of cholesterol in the bile.12 Other mechanisms of cardiovascular protection
by HDL-C involve anti-inflammatory, antioxidative, antithrombotic, and endothelial
stabilizing properties.13 General recommendations for decreasing obesity traditionally
include increased physical activity coupled with low total fat intake; however, low-fat,
high-carbohydrate diets have been found to contribute to increasing triglyceride and
decreasing HDL concentrations.14 In fact, this is what is found for these parameters in
the placebo group. The quality of carbohydrates has been studied in relation to car-
diovascular disease and metabolic disease risk.15,16 The glycemic index and dietary
fiber appear to play an important role in cardiovascular disease.15 No negative effects
were observed on HDL-C and triglyceride levels when an increase in carbohydrate
E. Linarès, et al
NeOpuntia and Blood Lipid Parameters
1122
intake is associated with low glycemic index food. Dietary recommendations based on
low fat and high carbohydrates, especially as defined by a low glycemic index, should
improve blood lipid parameters.
In contrast, our study demonstrates an increase in HDL-C levels due to
NeOpuntia consumption. This effect shows the highest significance in females older
than 45 y, with an HDL-C improvement of 7.1% (P=.029). Therefore, women in this
age group appear to benefit most from NeOpuntia. The consumption of NeOpuntia
induced a 0.0495 g/L increment in HDL-C levels, which can be associated with
a 14% decrease in cardiovascular risk. Improved HDL-C levels are especially impor-
tant for postmenopausal women, as women’s HDL-C levels generally decline after
menopause.17 In addition, the subgroup comparison shows an almost significant
trend towards a decrease in triglycerides in women over 45 y of age.
One mechanism by which NeOpuntia causes an HDL-C increase could be a pos-
sible intervention of the fibers of Opuntia ficus-indica with lipid absorption or bile
acids.9 Ziai et al18 showed a significant beneficial effect of dietary fibers derived from
Plantago ovata seeds on glycaemic control in diabetic patients, including significant-
ly increased HDL-C levels. In both cases, NeOpuntia and the soluble fibers derived
from Plantago spp. are defined by a low glycaemic index, which could be involved
in the observed beneficial effect on HDL-C levels.
The benefits of reducing LDL-C levels are well documented. Because LDL-C trans-
ports cholesterol to the arteries and can be retained there by arterial proteoglycans
starting the formation of plaques, increased levels are associated with atherosclero-
sis, and, thus, heart attack, stroke, and peripheral vascular disease. This is why cho-
lesterol inside LDL lipoproteins is called “bad cholesterol.” It is not the cholesterol
that is bad, however; rather, it is how and where it is being transported, and in what
amounts over time.
Increasing evidence has revealed that the concentration and size of the LDL par-
ticles more powerfully relates to the degree of atherosclerosis progression than the
concentration of cholesterol contained within all the LDL particles.19 The healthiest
pattern, though relatively rare, is to have small numbers of large LDL particles and
no small particles. Having small LDL particles, though common, is an unhealthy
pattern; high concentrations of small LDL particles (even though potentially carry-
ing the same total cholesterol content as a low concentration of large particles) cor-
relates with much faster growth of atheroma, progression of atherosclerosis, and
earlier and more severe cardiovascular disease events and death.
Analyzing the effect of NeOpuntia on the reduction of LDL-C in the total popu-
lation and comparing that result with the LDL-C–reducing effect on the subgroup
without other hypolipemic treatment, shows an inexplicable difference, especially at
D14 of the study: We can observe a significant trend demonstrating NeOpuntia’s
ability to reduce LDL-C (10% [P=.063] in verum against 3% [P=.491] for placebo).
The pronounced difference between the total population and the subgroup, the
apparent reduction in efficacy at D42 within the subgroup, as well as any potential
effect of NeOpuntia on LDL-C particle size, including any effect different particle
sizes can have on the accuracy of standard LDL-C determination, warrant further
investigation.
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Volume 24 No. 5, September/October 2007
1123
Oxidative stress may play a role in the pathophysiology of diabetes and cardio-
vascular disease20,21: The study of circulating antioxidant concentrations, in adults
with or without metabolic syndrome, showed a significantly lower concentration
of carotenoids for the participants with metabolic syndrome. Opuntia ficus-indica
contains antioxidant components in its leaves,1,4 especially carotenoids and lutein.22
Even if the effects of the cactus are generally attributed to the high fiber content of
the leaves, other active compounds, such as antioxidants, could be involved.7
In conclusion, the observed effect of NeOpuntia on HDL-C levels, as well as other
blood lipid parameters, shows a clear advantage for this nutritional supplement, com-
pared with placebo, for the management of metabolic syndrome. At the end of the
study, 39% of the NeOpuntia group, but only 8% of the placebo group, were no longer
diagnosed with metabolic syndrome. The impact of carbohydrate quality, coupled
with antioxidants in order to improve the protection against metabolic syndrome,
is in accordance with recommendations of high fruit and vegetable intake.14
ACKNOWLEDGMENT
This work was funded by BIO SERAE Laboratoires SA, Bram, France.
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