Reports on tasks for scientific cooperation
(Scoop)
d(click link for complete SCOOP report)Click for complete scientific and medical data report
Report of experts participating in Task 7.3
September 2002
Collection of data on products intended for use in very-low-calorie-diets
Directorate-General Health and Consumer Protection
The report documents the extent of the problem of overweight and obesity in the EU and corrects a number of misconceptions ie. that slow, small weight loss is better maintained or that rapid weight loss is unsafe.When the SCOOP Task 76.3 was first announced, the VLCD European Industry Group asked to submit a report which had been prepared by Dr John Marks (one of the members of the SCOOP committee and one of the authors of the above SCOOP document) in March 1998. The SCOOP Committee, during the first plenary meeting in Maastricht, The Netherlands on March 15th and 16th 2000 accepted this report.
A request was made by the SCOOP Committee that those sections of the report which were concerned with scientific and medical data be updated to early 2000 and submitted as a discussion paper. Subsequently a series of further papers was requested by the Committee and submitted in the years 2000 and 2001 by Drs John Marks and Jaap Schrijver..
The document which is referred to in the SCOOP Report to the EU Commission of August 2001 as Marks J and Schrijver J (2001) is the summation of all these reports from March 2000 to July 2001. This very detailed and lengthy scientific paper can be found on Dr Mark's web pages (click here) Dr Marks has, however, provided the Food Education Society with a summary analysis of the highlights of his paper with links to the supporting section of the paper for those interested in the relevant research documentation.
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This report reviews over 400 published scientific and clinical studies to early 2000, undertaken on VLCDs, on over 50,000 people. Thus it is likely that VLCDs are the most widely studied of all weight reducing diets. In addition, it records the main findings in a series of audit studies undertaken during the routine use of VLCD.The vast majority of the studies identify the compositional standards and the length of administration and this document concentrates on those papers. In almost 20,000 people, use was for more than four weeks, giving good evidence on safety of long-term use.
In addition current formula VLCDs have been used by well over 25 million people in the international community over a period of over twenty years.In addition to this critical review of the available safety and efficacy data in clinical use, there have been a substantial number of recent experimental studies which have shown that some of the earlier research reached erroneous conclusions. This report reviews this data and highlights some important new scientific conclusions which have practical implications.
Overall conclusionsA modern nutrient-complete VLCD provides a highly effective and safe method of weight reduction. The use of VLCD has benefits on excess weight related disorders which appear to be superior to those of LCD or food based plans probably on the basis of the more rapid weight loss.
On the basis of monitored clinical experience coupled with recent body composition studies a scientifically based standard for composition and labelling can and should be established for VLCD.
In view of the undisputed need to help the very large number who need to lose weight, as many safe methods as possible should be made easily and readily available. This includes VLCDs, where the safety can be shown to be at least as good as diets in the >800kcal energy range. VLCDs should therefore be available on free sale on the same terms as diets of over 800kcals (see Commission Directive 93/5/EC).
Overweight and obesity are rapidly and substantially increasing problems in all European Union Member States
Excess
weight has reached epidemic
proportions with some 20% obese and a further 30% overweight
(Section1.1)
Morbidity increases
from a BMI of about 24 . The problems associated
with excess weight include not only serious physical diseases, but also
psychological and social ills
Excess weight is strongly correlated with increasing
mortality.
The economic cost of excess weight is substantial.
THE SAFETY OF VERY LOW CALORIE DIETS IN EXPERIMENTAL AND CLINICAL USE
The
need for strict attention to prime data is high. Years of misinformation has led
to a large catalogue of ex-cathedra pronouncements.
These studies show that products with an adequate macronutrient and micronutrient composition, with an energy content in the range 400-800kcals per day (VLCD) are at least as safe as any other weight reducing diet. The safety applies not only to those in the higher BMI range but also to those with starting BMI levels down to 25 and finishing BMI levels in the normal range (20 to 25).
Click
the link for a summary of the
available published data on diets under 800kcals and for the
data reclassified according to energy and carbohydrate content.
A
full listing of these studies is given as Appendix I
and a full
bibliography for them is given as Appendix II.
Side effects of VLCD: A relatively
small proportion of those taking VLCD experience side effects. The risk of side
effects is greater if the dieter does not follow the directions given on the
diet pack or by any adviser (particularly of strict compliance to the diet and
to drink substantial quantities of water while taking the VLCD).
Gall Stones:( Cholelithiasis) Examination
of the literature shows that, with very rare exceptions, claims of increased
incidence of cholelithiasis with rapid weight loss are American. The European
literature is devoid of such reports and conversations with those European
experts who have used VLCD extensively confirm that gallstone formation has not
been a problem. Perhaps even more importantly, in those papers in which the
details of the weight loss programme are recorded, the majority stem from two
commercial weight loss products widely used in the USA but not in Europe.
Bone density: It is clear that, as could be logically expected, there is
a direct relationship between bone density and body weight. It is largely the
strains on the bones that determines their density. That is why elephants have
thick bones and orthodontists are able to move teeth. Whether weight is lost
intentionally (by whatever means) or unintentionally, the bone density is
reduced roughly in proportion to the loss of weight. Bone density is increased
with increasing weight and reduced proportionately with weight loss.
Eating Disorders: There is not one iota of data to support a causitive
relationship with dieting.
Resting Metabolic Rate: The initial reduction in resting metabolic rate (around 15%) is a physiological response to reduced food intake within the first few days of dieting and is not related directly to the actual energy intake or to the amount of weight loss. The subsequent long term reduction in the resting metabolic rate depends on the extent of the weight loss irrespective of the method and energy levels by which it is achieved
Continuous versus intermittent use: There is no
scientific reason for short term interruption of use, indeed from the point of view of
experience it is highly undesirable and de-motivating.
The weight maintenance results with VLCD are as good, if not better than with the use of other methods of dieting Weight cycling:(Yo-Yo dieting): Weight cycling does not lead to increased fat stores, reduced metabolic rate, and less effective weight loss with each cycle as was previously suggested
Body Composition Changes associated with dieting. Virtually all of the
resistance to the use of VLCD has centered on the allegation that VLCD might cause excessive loss of lean body mass in comparison with
other diets.
A vast amount of modern research has been dedicated to determining whether these concerns were warrented. It has been proved that there is no excessive loss of body lean, however for those interested in the scientific detective story resulting in understanding the reasons why the concerns were misguided, the next sections will prove illustrative.
Although
many older studies used Kjeldall nitrogen determinations for estimating protein
changes, the technique requires unusually great attention to detail to achieve reliability.
Conclusions from studies without validation controls (rarely used) should be avoided .
A
thorough examination of body composition estimation has indicated that there was
substantial lack of reliability and reproducibility in most of the methods that
have been used for weight loss studies.
Re-examination
of the old data and further new observations support the view proposed by Garrow
and others in the 1970s, that at all pre-dieting BMI levels between about 60 and
20, FFM represents about 25% of the weight loss (range about 20-30% probably
depending on genetic factors). This is true for any energy value diets
containing appropriate macronutrient levels including VLCD
On the
basis of the extensive amount of data reviewed the following compositional
criteria are proposed which would provide the following minimum daily intake:
Micronutrients: Internationally agreed levels should be adopted.
There is substantial medical and
scientific justification for modern nutrient complete formula diets with an
energy value less than 800kcals per day (VLCD)
There is recent convincing evidence that the rapidity
of weight loss confers additional positive health benefits independent of the
weight loss in, for example, non-insulin dependent diabetes mellitus and
hypertension.
The precautions
for VLCD use should be those which apply to any method for losing weight.
Having studied the
draft of the SCOOP Report on VLCD the authors of the discussion paper (Marks and
Schrijver) drew attention to some inconsistencies and contraindications within
the SCOOP Report.