High-protein energy-dense oral nutritional supplements trialled in patients

By Matt Chittock

- Last updated on GMT

getty | kdshutterman
getty | kdshutterman

Related tags Protein Malnutrition

A new Spanish trial suggests that, for patients with disease-related malnutrition, high energy-dense oral nutritional supplements (edONS) could be more efficient for patients than a reference supplement (heONS).

Currently, compliance for patients with disease-related malnutrition isn’t optimal for meeting their energy and nutritional needs. The authors of this new study note this may be because “energy-density or prescribed volume of ONS may impact compliance.”

The study, which received funding from Danone Specialized Nutrition, concludes: “Our findings highlight that edONS was non-inferior to heONS in terms of consumed energy over the prescribed, with a lower amount of edONS discarded, which suggests a higher efficiency of edONS.”

Background research

Disease-related malnutrition affects between 20% and 50%​ of hospital patients. It leads to poorer prognosis, longer hospital stays and poor quality of life, among other problems.

Oral nutritional supplements can be an effective treatment for malnutrition​. However, intake compliance is important to reduce waste and help patients reach their health goals. Product factors like energy density and volume should be looked at when considering compliance.

Currently, there’s no funding by the Spanish health system for high energy-density supplements. Yet previous research​ suggested consumption of energy-dense ONS (2.4 kcal/mL) results in a higher total energy and protein intake than standard hypercaloric ONS (1.5–2.0 kcal/mL). However, that study featured a small sample and a short follow-up period, so the authors believe more evidence is needed.

The study

The authors hypothesised that compliance with high energy-density ONS would be at least non-inferior to compliance with lower energy density ONS, with less product waste in the former.

So they carried out a randomised, open-label crossover trial in outpatients with disease-related malnutrition. They compared compliance between a high energy-dense ONS (edONS; Fortimel Compact Protein®; Nutricia, Danone, Madrid, Spain; 2.4 kcal/mL) and a reference ONS (heONS, Fortimel Extra®; Nutricia, Danone, Madrid, Spain; 2.0 kcal/mL).

Patients were randomly assigned to two eight-week treatment sequences of four-week periods: edONS + heONS (sequence A) or heONS + edONS (sequence B). Fifty-three patients were assigned to sequence A and 50 to sequence B. To reduce “taste fatigue”, patients had ONS with two different flavours – strawberry and vanilla. 

Patients recorded the amount of ONS left after they’d taken it on their smartphones. They were asked to collect the residue in a measuring cup and provide a photograph. They were also asked to share their satisfaction levels with the ONS, and any gastrointestinal symptoms.

The authors performed a non-inferiority analysis to compare the compliance rate (percentage of consumed energy over the prescribed) for each period and sequence.

The results

The trial found compliance with edONS was non-inferior to hEONS, confirming the authors’ hypothesis.

The author noted that as the amount of product discarded versus prescribed was higher with heONS, “this had a direct impact on cost, with the cost of discarded product being higher in this case, suggesting that edONS is more efficient, providing adequate caloric intake with a lower amount of product discarded because of higher compliance.”

The authors also noted that starting nutritional treatment with a low-volume ONS could reduce intake fatigue during treatment and that further studies were needed to test this.


The authors recorded several limitations. The trial was conducted in 2020 during the Covid-19 pandemic which meant patient enrolment suffered. Plus, both ONS study bottles featured different volumes – making a blind trial impossible. Patients were also weighed on different scales which could lead to small variations.

Source: Frontiers in Nutrition


"Compliance with a high-protein and energy-dense oral nutritional supplement in patients with disease-related malnutrition: a randomized open-label crossover trial"

Leon-Sanz. M., et al

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