Weight Management

Nutri Pharma's Very Low Energy Diet (VLED) and Low Energy Diet (LED) products have been extensively tested in a large number of clinical and pre-clinical studies. Highlights from this research are :

Preservation of muscle mass
Nutri Pharma’s VLED, Nutrilett®, has been shown to help preserve muscle mass in a study on 127 overweight volunteers[ 2]. In this 8 week study, the mean reduction in body weight was 12.7kg, of which 75% was fat.

In a trial involving 19 overweight patients with Rheumatoid arthritis[ 7], the conclusion reached was that “a high-protein-low-energy diet combined with exercise is capable of promoting a significant weight loss in patients with RA while at the same time preserving BCM (Body Cell Mass) and muscle function, and is without adverse clinical effects”.

A trial involving 32 obese women in a 12 week weight reduction programme[ 10], showed an average weight loss of 13.0kg. Different methods for measuring body fat were compared, and the recommended method calculated that the weight loss was 88% fat.

54 obese patients using a Nutrilett® VLED for 2 months[ 11] showed a 18.9 kg weight loss, compared to a 7.2 kg loss for a control group on a balanced hypocaloric diet of 1600 kcal/day. The weight loss of the VLED group was 68% fat.

Compliance with the Nutrilett® VLED
In a trial involving 253 obese volunteers, Nutrilett® was taken 5 times a day for 8 consecutive weeks[ 5]. Only 13% of volunteers failed to complete the trial, for various reasons, which demonstrated that Nutrilett® has a high level of acceptability. The few side effects noted by participants at the beginning of the trial rapidly diminished after the first 2 weeks. Average weight loss was 13.2kg.

Use of a VLED as part of a long term weight management programme
A one year long trial on 22 obese patients[ 6] studied the use of an 8 week intense weight loss programme using Nutrilett® followed by a balance hypocaloric diet (1600kcal/day) for the rest of the year. The patients achieved both an average weight reduction of 16kg and a final weight that remained stable over the final weeks of the trial.

In another study, 62 patients undertook a 17 week programme of weight reduction using Nutrilett® in conjunction with behaviour therapy[ 8]. Follow up visits were made at 1 and 2 years after the programme to assess the long term benefit of the programme.
 
After the 17 week programme, the average weight loss was 14.9kg. At the 2 year follow up, the average was 5.8kg. After 2 years, 71% of patients succeeded in maintaining a lower weight than at the start of the trial.

Comparison between VLED and LED
In a study of 93 obese patients, Nutrilett® VLED was compared to the Nutri Pharma LED formulation, using daily intakes of 420, 530 and 880 kcal[ 9]. In this 1 year trial, 6 weeks of meal replacements was followed by a balanced hypocaloric diet (1600 kcal/day), and then a further period of 2 weeks meal replacements after 6 months. The results showed no significant difference in weight loss between the VLED and LED approaches, and an average weight loss of 8-15% of initial body weight.

Use of VLED by patients with eating disorders
The conclusion of a trial involving 18 obese female patients with eating disorders[ 12] was “we found that by adding dietary treatment and exercise to bulimic patients treated with long-term psychotherapy, it seems possible to achieve a substantial weight reduction, improvement of self esteem and good compliance”.

Comparing continuous vs intermittent use of a VLED
A trial comparing a continuous 6 week VLED programme against use of 3, 2 week periods spaced a month apart showed no significant difference in overall weight loss[ 13]. Some patients found the intermittent approach easier to manage, and the use of a VLED for 2 week periods does not require medical supervision (in Sweden).

Reduction in cardiovascular risk factors
In a trial using 29 moderately obese women, a 17 week weight loss programme was followed up after one year to see if improvements in cardiovascular risk factors were maintained[ 14]. The average weight loss at the end of the programme was 15.1kg and, after a year, 10.7kg. At the one year mark, improvements in serum triglycerides, glucose level, waist circumference and HDL cholesterol level were maintained.

Use of a VLED with nicotine gum in smoking cessation
This trial[ 16] looked at whether use of a VLED helped 287 female smokers who had previously abandoned attempts at smoking cessation due to weight gain. At 16 weeks, 50% of the VLED group had given up smoking, compared to 35% of the control group. After one year, 28% of the VLED group compared to 16% of the control group were still not smoking.

Use of a VLED by patients with Asthma
Although obesity and asthma are not known to be causally associated, obesity may affect lung function and so cause worsening of the asthma. In this trial[ 17], weight reduction through the use of an 8 week Nutrilett® VLED was shown to improve lung function, symptoms, morbidity and health status in 19 obese patients with asthma.

Nutri Pharma’s LED product
This product, which was launched in the USA as Scan Diet®, was tested in a trial involving 100 obese volunteers[ 19], where the control group were advised to follow a diet according to the American Dietetic Association.
 
After 12 weeks, the LED group lost significantly more weight than the control group (7.1kg vs 2.9kg) and had greater losses of both total and LDL cholesterol.

Effect of rapid weight loss on diabetic patients
Nutrilett® was used in a trial on 11 obese patients with type 2 Diabetes[ 20]. The programme used was an LED rather than VLED, taken for 8 weeks at 850 kcal/day. The mean weight loss was 10.9kg and there were significant changes in plasma cholesterol (-20%), LDL cholesterol (-17%) and triglycerides (-39%), and a marked improvement in glycemic control.

Comparison between Nutri Pharma’s LED and a milk-based LED
This trial used Scan Diet® in comparison to the Slim.fast® milk-based LED using 90 overweight or obese patients on 1200 kcal/day for 12 weeks[ 21]. Average weight loss was 9.0% of body weight for the Nutri Pharma LED group and 7.9% for the milk-based group.
The reductions in serum cholesterol and LDL cholesterol were significantly greater with the Nutri Pharma LED at 6 weeks. At 12 weeks there was a significant reduction in serum cholesterol, LDL cholesterol and triglycerides with the Nutri Pharma LED but not the milk-based LED.