Don't Disturb Me!

Asphalia for Natural Sleep

 
Clinical Trial
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Introduction PDF Print E-mail

Asphalia (Don't Disturb Me!) is a melatonin-containing food supplement derived entirely from the dried and powdered leaves of gramineous species (wheatgrass, oats, barley, fescue) Historically, the first grasses were grown for their grains, providing the staple diets of virtually every society; wheats, ryes and barleys in Europe, maize in the Americas, millets in Africa and rice in Asia. Recent studies of plants reveal that gramineous species contain more melatonin than most fruits and vegetables. Only a decade ago was it first discovered that melatonin is also present in the seeds, leaves and roots of plants, particularly in graminaceous species, and that plant melatonin is bioavailable to the animal kingdom. A 1995 study reported that among plants, the graminaceous species Festuca Arundinacea contained more melatonin than any other plant. It is this plant which forms the basic ingredient of Asphalia (Don't Disturb Me!). Studies at MIT concomitantly reported that pharmacological doses of melatonin (i.e. in the milligram range) were not as effective as physiological doses (i.e. in the micro/picogram range).

Accordingly, the rationale behind the unique development of Asphalia (Don't Disturb Me!) by Coghill Research Laboratories was that the natural plant-derived product is arguably more effective than the synthetic melatonin produced mainly as a by-product of chocolate manufacture, and when delivered in physiological doses would also prove to be more effective over time.

 
Brief literature review of melatonin clinical trials PDF Print E-mail
Scientific literature on melatonin has quickly grown to extend to more than ten thousand peer reviewed studies, so great is scientific interest in this hormone. Confining attention to clinical trials on sleep in normal healthy subjects following melatonin administration reveals at least 22 clinical trials in the last 20 years, of which nearly all report a positive effect of melatonin on various sleep parameters. In all cases, however, only synthetically produced melatonin was trialled. Our study is the first to report on the biological effects of melatonin derived from natural plant materials.
 
Method and Materials PDF Print E-mail

The study protocol is of randomized double blind placebo-controlled design.

The safety of short term melatonin administration was confirmed by reference to a recent meta-analysis which reported that 17 randomized controlled trials showed no adverse effects of melatonin with short term use of three months or less. The separate ingredients of Asphalia are all well established as non-toxic traditional ceral related foods or grazing forage for livestock. The variety of fescue seed supplied was of an endophyte-free strain and this was cultured for two years in organic soil. Only the air-dried leaf was used to mill the final powder and at a slow speed to avoid denaturing the protein content of the plant. When ground, the powder was maintained at 4 degrees Centigrade until posted to the subject for administration.

Candidates were recruited into the study via a heterogeneous population spread across the U.K. who identified themselves to a website (www.mastsanity.co.uk) advising the general public on health effects from chronic exposure to radiations emitted by cellphone masts. Candidates were provided with an informed consent form describing it as a meadowgrass powder similar to barley and wheatgrass powders. No mention was made that the aim of the study was to assess sleep improvement symptoms or minor ailments commonly associated with EMF exposure in epidemiological studies of radiation sickness.

Blindness was obtained by ensuring that the subjects were unaware whether they were receiving a placebo or a sample, anmd the analysis of questionaires were carried out by one of us (RWC) without knowing whether the response related to placebo or sample.

Successful candidates were asked to take one dose of the sample/placebo, allocated randomly between subjects so that though overall they underwent one fortnight period of taking the sample and one fortnight of taking the placebo, the order was randomly allocated.

Questionnaires were in three parts, the first to be completed before starting the four week course, the second two weeks into the course and the third at the end of the second two-week exposure levels.

 
Results PDF Print E-mail
Of the 22 candidates who completed Consent Forms, 16 people completed the test and their questionnaires. Of those 16, 8 were female and 8 were male. Average age was 48.4. 7 subjects reported improvement in sleep, 1 subject reported feeling calmer and 7 subjects reported no change or noticeable effect. No candidate reported deterioration in health conditions at the conclusion of the trial period, but 7 subjects reported improvement. Follow-up at six months established that this lack of deterioration had continued and that several of the subjects were now regular satisfied users of Asphalia (Don't Disturb Me!). We interpret the mean positive overall score to indicate a moderately successful sleep improvement trend overall during the active period compared with the placebo.
Last Updated ( Friday, 01 May 2009 01:49 )
 


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