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Fatty Liver Study

Effective nutritional and
dietary modification can improve Fatty Liver – by Dr Sandra Cabot and
Simone Abaron ND.

Background

Dr Sandra Cabot, along with naturopaths and many other holistic doctors,
have implemented dietary and lifestyle changes as well as nutritional and
herbal supplements for over thirty years to assist their patients in the
reduction of fatty liver and weight excess.

This need for information regarding the reduction of fatty liver is a
result of the rising number of people being affected by it, together with
the limitations of medications for this type of liver injury. Dr Cabot
noticed the escalation of fatty liver in her private practice and from
feedback from the general public, which motivated her to do this
observation study.

The Medical Observer Journal of Australia in July 2004 published an
article titled Non-alcoholic fatty liver disease is the new epidemic
of liver disease facing the Western world
. Well it has been
gradually creeping upon us, but in reality it has been an epidemic for at
least a decade now!

Back in the 1980s fatty liver was mainly seen in alcoholics and rarely in
children. Today fatty liver is now recognised as the most
common cause of abnormal liver function tests
in the USA,
UK and Australia. Around 20-25% (or 1 in 4-5 persons in the general
population) in Australia and the USA has fatty liver disease.

Fatty liver occurs when fat accumulation is more than 5% of the liver
weight. Fatty liver is most commonly caused by incorrect diet, obesity,
alcoholism and diabetes. Other causes can include malnutrition
(especially protein deficiency), congenital metabolic disorders,
excessive use or toxicity of orthodox medications (such as
corticosteroids, valproic acid, tetracycline, salicylates or synthetic
oestrogens) or systemic illnesses with fever.

Aim

The aim of this observation study was to illustrate the result of a
specific supplemental and dietary regime on liver tests that indicated
fatty liver over a 5 to 6 month period.

Hypothesis

We were hoping to demonstrate:

  • Improvement in liver function
  • A reduction in clinical symptomatology
  • A reduction in obesity – This was going to be challenging as 50% of
    participants could be classified as obese by their BMI and furthermore,
    it is traditionally thought that those with a fatty liver find it more
    difficult to lose weight.
  • A reduction in the amount of the fatty infiltration of the liver.
  • Improvement in the quality of life and general health

Because this study period was conducted over a relatively short time
(between 5 to 6 months), we were not expecting to completely reverse the
condition of fatty liver, which is generally thought to take many years to
develop. We do not claim that damage to the liver will always be completely
reversed by the program outlined in our study.

Study Design

This study was designed as an investigative initial clinical study.

Participant Recruitment and Selection

Participants were recruited by replying to advertisements placed on
health websites, by word of mouth and from patients in Dr Cabot’s
clinics. Applicants were then asked to complete a questionnaire, which
was consequently analyzed and compared with a set of predetermined
selection criteria. Participants’ suitability was then determined
according to this.

Applicants needed to fit into the following selection criteria:

  • Had a previous medical diagnosis of Fatty Liver
  • Had a positive ultrasound confirming the diagnosis of Fatty Liver
  • Did not have advanced cirrhosis of the liver or liver failure
    indicated by symptomatology and/or pathology
  • Did not have other pre-existing, serious, medical conditions such as
    kidney failure, heart failure, cancer, psychotic illness etc
  • Was not a smoker at time of application
  • Did not drink more than 4 alcoholic beverages per week at time of
    application
  • Did not use recreational drugs at time of application
  • Was not taking orthodox medication (or was willing to stop medication
    after discussion with their doctor) which may have hepatotoxic effects
    (eg. statins and long term antibiotics)
  • Was willing to terminate the use of all dietary supplements known to
    have any effect on liver function
  • Was motivated and enthusiastic to change their diet
  • Was willing to comply with various demands of study executives
  • Was willing to have specific tests required such as blood tests and
    abdominal ultrasound
  • Was willing to have their results published and allow medical
    professionals to view results to vindicate results of study
  • Must have filled in and signed a consent form

Once the applicant was deemed suitable, they were then called into Dr.
Cabot’s Holistic Health Clinic in Camden, Sydney Australia for an initial
consultation with Dr Cabot and Naturopath Simone Abaron, the study’s
project director. Successful applicants were accepted in either the first
or second round of inlets which commenced 3 months apart from one
another.

Supplement Protocol

Participants were instructed to take 2 capsules twice daily of a
specialized liver tonic called LivaTone Plus. These were provided to the
participants at no charge for the duration of the study period.

No other nutritional/ herbal supplements with known effects on liver
function were permitted to be taken during the study period. Orthodox
medications prescribed to participants before the commencement of the
study by their pre-existing medical practitioner, were permitted to be
continued during the study, provided they did not have known hepatotoxic
activity.

Dietary & Lifestyle Protocol

Participants had to carry out all dietary modifications suggested by the
research team. The dietary protocol for participants was similar to that
outlined in Dr. Cabot’s book
Can’t Lose Weight? Unlock the Secret that KEEPS you FAT
. In this
program, carbohydrate intake is limited and the importance of eating
complete protein and fresh vegetables, high in antioxidants, on a regular
basis is emphasised.

Participants were expected to make and drink raw vegetable juices at
least 4 times a week. Suggested recipes were outlined in Dr Cabot’s book
Raw
juices can save your life
Appropriate recipes included the Liver
Tonic, Liver Cleansing, Fatty Liver and Weight loss juices.

All participants were permitted to have a maximum of 4 alcoholic
beverages weekly. Complete exclusion of smoking and recreational drug use
was imperative. Exercise was strongly encouraged however it was not a
fundamental modification.

Compliance

Because this program was very demanding on participants, it was
imperative to ensure enough contact was maintained between participants
and the study’s management, in order to ensure compliance was maintained.
As a result, it was necessary for all participants to attend fortnightly
follow-up consultations at Dr Cabot’s Holistic Health Clinic with
naturopath Simone Abaron. In addition, participants were required to
complete a daily diet diary for the duration of the study, which was
reviewed at their fortnightly follow up consultations.

Patients were provided with the necessary supplements, health books and
an excellent Samson juice extractor machine free of charge, so as to make
their compliance as easy as possible. If a participant did not comply
with suggestions made by study executives they may have been excluded
from the study process at any time.

Study Method

Monitoring of specific tests known to be indicative of, or associated
with, the liver damage caused by fatty liver was organised at accredited
pathology laboratories. In some cases, these measurements may also
predict the degree of fatty infiltration of the liver. These tests were
done at the commencement and conclusion of the study.

These included:

  • Abdominal ultrasound scan
  • Liver function enzymes
  • Lipid studies including HDL
  • Fasting blood glucose
  • Fasting insulin

Clinical history and measurements were taken at the commencement,
conclusion and at all fortnightly consultations over the study period.
These included:

  • Fatigue levels
  • Digestive discomfort
  • Mental and physical wellbeing
  • Room for individuality of presentation was allowed with one symptom
    possibly related to liver dysfunction being monitored throughout the
    length of the program
  • Body weight
  • Body Mass Index
  • Waist circumference
  • Blood pressure

Discontinuation of the Study

Foot injury in week 10, resulting in inability to stand and prepare
food for herself. Husband assumed the responsibility of preparing meals,
which was not conducive to complying with the program.

Patient Reason for discontinuation
Fatty Liver Mr. C Emotional hardship- at the entrance into the study, this patient
was suffering with emotional issues and severe depression, which
had been a problem for this patient for many years. By week 12,
this patient found he was no longer able to comply because of these
psychological factors.
Fatty Liver Ms. E Foot injury in week 10, resulting in inability to stand and prepare food for herself. Husband assumed the responsibility of preparing meals, which was not conducive to complying with the program.
Fatty Liver Ms. G Developed an extreme lack of motivation in week 18 after being
employed on a full-time basis.

Table 1: Reasons for participant discontinuation

Considering the demands this study required, the overall abandon rate was
surprisingly low. This could be attributed to the level of compliance
assurance measures undertaken such as the daily diet diaries and the
level of support the participants received on a fortnightly basis. It may
have also been attributed to the significant improvements in fatigue
levels, overall wellbeing and other concerning symptoms.

The study commenced with 9 participants being included. Of those, 6
participants completed the program. Therefore the overall abandon rate was
33%.

It should be pointed out that during the course of this clinical study,
no patients experienced significant side effects from the treatment
protocol.

Considerations

During the course of this investigative observation study, certain
unavoidable problems were presented, which should be considered when the
results are being viewed and conclusions made. Fatty liver is generally
considered to be a chronic problem, with most of the participants
commencing to develop it many years before the study.

We did try to recruit 12 study participants but found this difficult for
unknown reasons. Diagnosis of fatty liver is often overlooked, even
though it affects around 20-25% of the general population. This low
detection rate has allowed for the unnecessary progression of the
condition. As a result of the comparatively short time frame this study
was conduced over, significant changes in liver pathology were not
expected. In addition, because of the length of time fatty liver had
presumably developed over, difficulty was experienced in evaluating
initial clinical symptoms because the participants had developed them
very slowly. As a result, clinical measurements were, in many cases, not
quantitatively significant, however qualitative description revealed
there were significant benefits found.

Abdominal ultrasound scans were used to detect the presence or absence of
increased echogenicity caused by fatty infiltration of the liver. An
abdominal ultrasound scan is able to detect the presence of fatty liver
and grade it as mild, moderate or extensive.

Results

Symptom 1: Fatigue Fatigue was measured on a scale of
1 – 10. A value of 10 describes a severe degree of fatigue that affects all
aspects of the patient?s life. Overall, 83 % of participants had fatigue
levels, which had either reduced or remained consistent throughout the
study period. 17% of participants were more fatigued at the conclusion of
the study than they were initially. There was a general reduction of
fatigue by 6.7%. Symptom 2: Digestive Discomfort

Digestive discomfort was measured on a daily basis per week. That is, the
participant was asked how many days over the previous week they had
experienced digestive discomfort. Digestive discomfort may encompass
symptoms such as bloating, nausea, constipation, diarrhea, excessive
flatulence or burping, abdominal cramping or halitosis. 100% of the
participants received significant reductions in digestive discomfort. In
fact, on average, participants had a 70% improvement in their digestive
symptoms. Chart 1 illustrates the degree of change each participant found
from the commencement of the study period to the conclusion.

Chart 1: Digestive Discomfort

Symptom 3: Mental and Physical Wellbeing.

Mental and physical wellbeing was measured on a sliding scale of 1 -10.
The value of 10 represents a feeling of extreme mental and physical
wellness. Positive mental and physical wellness describes a feeling that
the participants? diagnosis with fatty liver was not impacting on their
wellbeing either mentally or physically. On average, mental and physical
wellbeing had improved by 13%. Chart 2 represents the participant’s
overall feeling of mental and physical wellbeing from the commencement of
the study period to the conclusion.

Chart 2: Wellbeing

Symptom 4: Individual symptom related to liver
dysfunction.

Because this clinical study was designed to acknowledge individual
presentations of the same disease process, this symptom allowed for
uniqueness of presentation. Participants were asked to describe their
most troubling symptoms at their initial consultation. Any symptom that
the study executives attributed to compromised liver function was then
monitored as symptom 4 throughout the length of the program. This was
measured on a daily basis per week. That is, the participant was asked
how many days over the previous week they had experienced their
particular individual symptom. Chart 3 illustrates the changes noted in
the frequency that participants experienced their individual symptom.

Patient 1 experienced uncomfortable bowel movements, patient 2 had severe
halitosis, patient 3 found their sleep quality was poor, patient 4
suffered with red itchy eyes, patient 5 experienced severe nausea and
patient 6 found he had problems with concentration and mental clarity.

Chart 3:
Individual Symptom

Weight

Weight gain is a sign which is commonly associated with the development
of fatty liver. Furthermore, weight gain is further accelerated by the
progression of fatty liver. Weight loss is therefore a great predictor of
a reduction in the degree of fatty infiltration. 100% of the participants
experienced a significant weight loss with the average weight loss being
14.5 kg.

Chart 4:
Weight Loss per participant in kilograms

Body Mass Index (BMI)

Body mass index describes an individual’s body weight compared with
their height. It is useful in determining whether one fits into the normal
healthy weight range or not. BMI brackets are as follows: Underweight =
< 18.5 Normal = 18.5 – 24.9 Overweight = 25 – 29.9 Obese = > 30 100%
of the participants had a reduction of their BMI. The average reduction for
participants? BMI was 4.9%

Chart 5:
Body Mass Index (BMI)

Abdominal Ultrasound

Abdominal ultrasounds are an effective tool in determining the
presence or absence of fatty liver. 83% of participants’ abdominal
ultrasounds showed some degree of reduction of fatty infiltration. Figure 1
illustrates the degree of change noticed in abdominal ultrasounds of
participants.

Figure 1:
Abdominal ultrasound changes

Pathology Tests

The pathology tests were chosen to evaluate liver function and fat and
sugar metabolism. Fatty liver may or may not cause abnormal liver
function tests, however an elevation of liver enzymes is indicative of
liver inflammation. Fatty liver is often associated with an abnormal
lipid profile and impaired glucose tolerance and insulin resistance.
Table 2 provides the average levels of the pathology parameters tested at
the commencement and conclusion of the study. Table 2 also provides the
average change over the period of the study.

Pathology Test Reference
Range
Average level at
commencement
Average level at
conclusion
Average
Difference
ALT (U/L)
0 – 40
43
28
- 15
AST (U/L)
0 – 40
30
23
- 6.3
GGT (U/L)
0 – 45
42
30
- 11.8
ALP (U/L)
30 – 115
74
64
- 10.1
Total Cholesterol (mmol/L)
3.9 – 5.5
4.7
5.4
+ 0.67
HDL (mmol/L)
0.8 – 1.7
1.2
1.4
+ 0.23
LDL (mmol/L)
1.7 – 3.5
3
3.3
+ 0.30
Triglycerides (mmol/L)
0.5 – 1.7
1.1
1.4
+ 0.28
Fasting Blood Sugar (mmol/L)
3.6 – 6.0
5.52
5.38
- 0.13
Fasting Insulin (mU/L)
0 – 20.0
15.68
11.18
- 4.53

Table 2: Pathology tests

Conclusion

This investigative observation study has provided clinical and laboratory
evidence that indicates liver injury caused by fatty liver, and fatty
infiltration in itself, may be significantly reduced, when effective
dietary, supplemental and lifestyle modifications are implemented.

Considering that:

  • At present, there is no orthodox medical treatment, apart from weight
    loss, that is proven to effectively treat or manage fatty liver or its
    consequences.
  • Fatty liver is associated with diseases such as obesity and diabetes.
  • Fatty liver and especially the more insidious form of NASH may
    progress to severe liver disease. There is an urgent need for proven,
    effective complementary medical protocols that cause no harm.

Nutritional medicine is increasingly recognized by many health workers as
being an extremely useful tool in achieving a reduction in morbidity and
mortality rates for the epidemic of degenerative diseases and obesity now
facing the developed world.

Although this study only involved a very small sample of people,
we consider the treatment outlined in this observation study to be
effective in reducing fatty infiltration of the liver and enhancing
weight loss.

Furthermore, throughout this observation study, no noteworthy
side effects were noted.

These statements have not been evaluated by the FDA and are not intended
to diagnose, treat or cure any diseases.