July 2006 : MOODCAPS™: INFORMAL Trial

PROTOCOL (PARTIAL):

INTRODUCTION:
MOODCAPS™ is a precursor formula (based on international literature and known metabolic pathways) for utilization by the body in the production of its own natural substance S-Adenosylmethionine ( SAMe). SAMe is known in the body as a "Methyl donor" which is responsible in the body for increasing the levels of the body's neurotransmittors; serotonin, dopamine and norepinefrine et. al.

In the process of metabolizing SAMe, the independent coronary artery disease risk factor Homocysteine, which is a breakdown product of amino acid metabolism, is produced. Fortunately this Homocysteine is remethylized back into the "core" (Essential) amino acid Methionine. In this same cycle the body's major antioxidant Glutathione is produced by means of a process known as "Trans-sulphuration" and is mainly stored in the liver, hence the major antioxidant properties of SAMe.

Functions of SAMe in the body: (main)*
1.Major antidepressant.
2.Liver detoxification (Glutathione effect).
3.Mild osteoarthritic symptom relief, reputed to improve the quality of cartilage.
4.Also used for fibromyalgia.
* for further information read the marketing brochure and the "Consumer information leaflet" or contact info@fusionformulations.com

Object of the "Trial"

This is simply to show that MOODCAPS™ are imitating, what the body's own SAMe is doing naturally (very unstable and expensive in the chemically produced form. See also "Optimum Nutrition for the Mind" page 116).

It is, in this limited study, basically a threefold enquiry:

1. Are Moodcaps™ raising the levels of Serotonin in the body and thereby an aid in the treatment of Clinical Depression and thereby also explaining the already known and observed properties?( the other previously mentioned brain neurotransmittors are not being assessed in this trial)

2. Homocysteine levels: are they static, or perhaps even decreased by the use of MOODCAPS™?

3. Glutathione levels in the serum: are they static or being raised by the use of MOODCAPS™?
Note: The obvious 4th product for testing, SAMe cannot be tested for in South Africa at this stage. Dependant on what the outcome of this trial is, this is obviously what we would want to test for in the future.

MOODCAPS™ ingredients and some of their sources
1.Methionine, an essential amino acid, which means that the body does not produce it's own, is found in high protein foods such as meat, fish and eggs.
2.Folic acid, found in green leafy vegetables, dried yeast, liver and mushrooms.
3.Vitamin B6 (pyridoxine), fish, whole-grain cereals, organ meats, liver and dried yeast.
4.Betaine: Which has an independent controlling effect on Homocysteine levels;
found in fish, beet and legumes.
5.Vit B12 is not included. Pernicious anaemia patients need to supplement (normal levels) for the optimum effect.

OTHERS:
Magnesium, phosphates and calcium.

HISTORY OF MOODCAPS™
MOODCAPS™ first came onto the South African Nutritional market in September 2000 as an all new locally researched and formulated product (Precursor formula) for use as an aid in the treatment of Depression. There are no known equivalents.

From the very outset the product proved to be very effective and without any reported side effects. The only contra-indication being Bipolar (Manic) Depression. This CI has been arbitrally made because of the postulate that if MOODCAPS™, as is the case with SSRI medicines, raise serotonin levels in the body, this in turn could also heighten the "Manic" phase of Bipolar (Manic) Depression.

Early marketing created the misunderstanding that MOODCAPS™ and SAMe were one and the same. This was corrected by changing the labelling (Jan 2002) and has since been known as (what it in fact has always been) merely a precursor formula package, which the body can utilize to produce natural SAMe. Proposed future testing hopes to show this.

The prime motivation for using the product was Depression, but the very strong second leg of its indications needs to be acknowledged i.e.

Liver Detoxification
Liver detoxification refers to its use in patients that have the after-effects of Viral Hepatitis and liver damage due to chronic or acute alcoholism and during and after drug misuse rehabilitation. Its usefulness in "Binge" drinking is obvious. If Glutathione levels are seen to be increased or normalised by the use of MOODCAPS™, then this quality will have further significance in Heavy metal/element (eg. mercury, cobalt et al) detoxification, with industrial implications. The product is safe in pregnancy and breast-feeding and can be used concurrently with any medicines. For the purpose of this trial the product will not be offered to patients already on antidepressants (This can and has been done successfully in clinical practice).

EFFICASY
As in the case of refined, chemically produced ( if still active*), SAMe (unstable despite the enteric coated tablet form that has to be used), MOODCAPS™ can be expected to show its antidepressant properties within the first 3 weeks of usage (if effective for the particular person). They will not work any better or faster than the Allopathic medicines, but thus far there are no reported Side Effects, unlike the effect that some Pharmaceuticals have on patients. However, the product has been seen to work as well as Tricyclic antidepressants and the SSRI drugs. Another advantage is the safety profile especially when compared to Tricyclic antidepressants.

Because of the product's stability beyond its expiry date, the possibility of an extension of the expiry date is being investigated in contrast to chemically produced SAMe.

* Ref. Patrick Holford's latest book "Optimum Nutrition for the mind" pg.116 where he refers to commercially available SAMe on the shelves which may be inactive by the time the consumer buys it off the shelf. "A lot of SAMe sold in health food shops is pretty ineffective." Now costing +/- R438.00 for a month's supply when used correctly at 400mg/day in South Africa.

DURATION of the Trial
Each Patient will be evaluated over at least a three (3) month period.

All tests will have to be done twice.

BLOOD TESTING
1.Serotonin
2.Homocysteine and
3.Glutathione

MATERIAL used

ZUNG test questionnaires and assessment pages. This quick assessment test was developed by the American Psychiatrist Dr William W. K. Zung and first published in 1974 and modified in 1989. It is recommended and used by the American Society of Family Physicians.

SIZE OF The Trial

At least a complement of 24 patients will be required to complete the trial in order for the results to be of any statistical value.

GENERAL

(A) MOODCAPS™

Please note that the patient needs to be informed that MOODCAPS™ are a Nationally "Branded" product and have been on the South African market for over 5 years. They are therefore not being asked to use an unknown new product or a product with unknown characteristics. The product has been successfully used in private medical practice without any reported Side Effects.
For the sake of repetition, the motivation for this trial is to hopefully illustrate that MOODCAPS™ are doing what the International literature has intimated SAMe does for Depression via Serotonin, homocysteine control and by the raising of Glutathione levels as measured in the serum.

WE ARE NOT TRYING TO SHOW THAT MOODCAPS™ WORK, THIS WE KNOW. RATHER, WE WANT TO SHOW WHY THEY WORK SO WELL

However, it must be reiterated that the trial also hopes to show that MOODCAPS™ will be successful as an aid in lifting the depression score levels of up to 70% of patients on this trial.

The associated odour when opening the container is normal.

(B) DEPRESSION per se.

Patients with an index score of 55 and below should be encouraged to start up an exercise programme as well as to modify their Life Styles. They should especially give attention to their eating patterns. "You are what you eat" or in many cases, "You are what you don't eat". The environment in which they become depressed will also have to be modified in order to have a long term sound prognosis. Smoking and excessive amounts of coffee must be excluded. The above is of course relevant to all depressed patients, whatever their level of depression may be.

All patients will be supplied with a marketing brochure referring to the known beneficial uses of SAMe, some of which, (Depression, Liver detoxification, Fibromyalgia) MOODCAPS™ have thus far been seen to emulate.