RCT backs targeted medical nutrition drink for muscle-wasting benefits

The randomised controlled trial (RCT), published in the Journal of Cachexia, Sarcopenia and Muscle, included 45 individuals aged over-50 suffering from Chronic Obstructive Pulmonary Disease (COPD) and who were experiencing either cachexia or pre-cachexia.

Cachexia is characterised by involuntary weight loss, skeletal muscle wasting and undernourishment. It is common in patients with COPD.

Participants who consumed Remune, a targeted medical nutrition (TMN) drink developed by Smartfish AS, Norway, twice daily for 12 weeks significantly improved fat mass, lowered systolic blood pressure and improved blood lipid and metabolic biomarkers, compared with the control group.

After adjusting for COPD severity, the intervention group also showed a significant reduction in fatigue and breathing difficulties (dyspnoea), reported the multi-institutional research team from the Universities of Southampton, Rome, and Maastricht plus the Karolinska Institute, Stockholm.

The formulated nutrition drink is juiced-based with plant antioxidants and high levels of omega-3, vitamin D, whey protein and polyphenols. It has been specifically designed as a nutrition support vehicle for patients with cachexia.

“TMN containing high-dose omega-3 fatty acids, vitamin D, and high-quality protein is well tolerated with a good safety profile and has positive effects on blood pressure and blood lipids,”​ wrote first author Philip Calder from the University of Southampton.

“Dyspnoea and fatigue that was measured pre and post walk (particularly post walk) was statistically significantly lower in the treatment group,”​ commented Maria Öhlander, Chief Scientific Officer at Smartfish AS, who worked with the university-based researchers on the study.

The intervention group also benefitted from a clinically relevant improvement in activity-related quality of life, as measured by the St. Georges Respiratory Questionnaire (SGRQ). Quality of life is a very important factor in cachexia patients, explained Öhlander. 

“What is interesting about the study is that it ​[the benefit] is translated into the quality of life. A clinically significant change is a four point change on the scale and we had an 8 point change over   12 weeks,”​ she commented.

Safety and tolerability​

Although the study displayed promising results with respect to efficacy, safety and tolerability of the beverage was the researchers prime concern

“Because this was a new drink, we did not know the magnitude of effects to expect,”​ explained Maria Öhlander, Chief Scientific Officer of Smartfish AS.​

Rather than having efficacy as the key endpoint, “we did this as a safety and tolerability study which was our primary objective,”​ continued Öhlander.

“It is completely safe and tolerable, we had good compliance and very few side effects in both groups,”​ she added.

Placebo design​

The design of the placebo (or comparator) product was a particular strength of the study, the researchers proposed. The comparator was not only isocaloric to the treatment product, but it also contained a relatively similar macronutrient composition, substituting sunflower oil for omega-3 and milk protein for whey.

The future​

Remune may have potential applications in other chronic illnesses where cachexia is present. These include cancer, AIDS, congestive heart failure and rheumatoid arthritis.

The TMN beverage may eventually be of benefit in improving energy levels and patient quality of life in all of these conditions, advocated Öhlander.

“What we are hoping to be able to say is that Remune is a beneficial treatment for patients with cachexia regardless of underlying disease,” ​concluded Öhlander.

Öhlander hinted that Smartfish may reveal further interesting developments at the Society on Sarcopenia, Cachexia and Wasting Disorders (SCWD) conference in Rome in December.

Source:  Journal of Cachexia, Sarcopenia and Muscle​

Published online ahead of print.   DOI: 10.1002/jcsm.12228​​

“Targeted medical nutrition for cachexia in chronic obstructive pulmonary disease: a randomized, controlled trial”​

Authors:  Philip C. Calder, Alessandro Laviano, Fredrik Lonnqvist, Maurizio Muscaritoli, Maria Öhlander, Annemie Schols