Study: Medical food with omega-3, leucine and probiotic an effective sarcopenia treatment

By Nikki Hancocks

- Last updated on GMT

getty | deagreez
getty | deagreez

Related tags Inflammation Probiotic Muscle Healthy ageing

A new randomised clinical trial of a medical food composed of omega-3, leucine, and probiotic Lactobacillus paracasei PS23 has concluded that this could be considered as a treatment for sarcopenia in the elderly.

Sarcopenia - an age-related condition characterized by decreased muscle mass, strength, and structural alteration, with increased fat mass - is estimated to affect 5-20% of individuals aged 60–70 years, as many as half of those aged 80 or above.

Nutritional treatment currently recommended is based on adequate dietary protein and amino acid intake with vitamin D supplementation.

However, supplementation with branched amino acids, including leucine - well known for their anabolic effect - has shown promising results in treating sarcopenia​. Omega-3 fatty acids have also been shown as effective in supporting muscular performance​.

And probiotics have shown promise in the prevention of age-related health decline. Animal studies have found the probiotic Lactobacillus paracasei PS23 (LPPS23)​ can decelerate age-related muscle loss​ and age-related cognitive decline​.

The current RCT therefore aimed to evaluate the effectiveness of a 2-month administration of a medical food composed of omega-3 fatty acids (500 mg), leucine (2.5 g), and probiotic Lactobacillus paracasei PS23 (LPPS23)​, on appendicular lean mass (ALM), muscle performance, inflammatory status, and amino acid profile in sarcopenic patients.

The placebo-controlled study, involving 60 participants, concludes that ALM increased significantly in the intervention group (p < 0.05), with no discernible change in the placebo group. Similarly, significant differences were also observed for the Tinetti scale (+2.39 points, p < 0.05), the SPPB total score (+2.22 points, p < 0.05), and the handgrip strength (4.09 kg, p < 0.05).

Visceral adipose tissue significantly decreased in the intervention group compared to the placebo group at 60 days −0.69 g (95% CI: −1.09, 0.29) vs. 0.27 g (95% CI: −0.11, 0.65), groups difference −0.96 (95% CI: −1.52, 0.39, p = 0.001).

A statistically significant increase in levels of valine, leucine, isoleucine, and total amino acid profiles was observed in the intervention group compared with the placebo group at 60 days (p = 0.001).

The researchers conclude: "The findings of this study indicate that the administration of a food for special medical purposes based on omega-3 polyunsaturated fatty acids, leucine, and the probiotic LPPS23 appears to be a valid strategy to counteract the progression of sarcopenia and sarcopenia-defining parameters in older adults."


A total of 60 participants (aged 79.7 ± 4.8 years) were enrolled and randomly assigned to either intervention (n = 22) or placebo group (n = 28).

A personalised nutritional schedule was prepared for patients in both groups that provided 1.5 g of protein per kg of body weight per day. Calorie intake was evaluated by a trained dietitian. The dietary scheme consisted of about 55% of carbohydrates and 30% of lipids.

In addition, weight history was evaluated by observing any weight loss compared to the usual weight and during the six months prior to the baseline visit.

The compliance with the dietary intervention was assessed through the 24 h-dietary recall once a month for three months.

Moreover, during follow-up calls conducted by study dietitians and the in-person dietitian consultation once a month, all participants were asked: “How well have you been following your diet plan?”.

Similarly, the same questions were asked for adherence to physical activity prescriptions. Self-rated adherence scores assisted with identifying participants’ barriers to change and setting personal diet and physical activity goals to achieve by the next follow-up call.

Subjects were randomly allocated to receive once daily the experimental formula: omega-3 fatty acid (500 mg, consisting n 64.71% EPA, 29.41% DHA and the remaining 5.88% omega-3 in general), leucine (2.5 g), probiotic LPPS23 (“30 Billion”, freeze dried) (OLEP), or the control formula: isocaloric placebo with the same flavour. 

All-in-all, assessed measures included: Anthropometric, body composition, muscle strength, functional status, physical performance, quality of life, mood, blood pressure, and biochemical parameters.

Source: Nutrients

"Effectiveness of a Novel Food Composed of Leucine, Omega-3 Fatty Acids and Probiotic Lactobacillus paracasei PS23 for the Treatment of Sarcopenia in Elderly Subjects: A 2-Month Randomized Double-Blind Placebo-Controlled Trial"

Authors: Rondanelli, M.; Gasparri, C.; Barrile, G.C.; Battaglia, S.; Cavioni, A.; Giusti, R.; Mansueto, F.; Moroni, A.; Nannipieri, F.; Patelli, Z.; Razza, C.; Tartara, A.; Perna, S. 

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