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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 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.

A 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 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.

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:  

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.