AdNut study: effectiveness of a high calorie and protein oral nutritional supplement with β-hydroxy-β-methylbutyrate in an older malnourished population in usual clinical practice

Abstract

ObjectiveTo evaluate the effectiveness of a high calorie and protein, β-hydroxy-β-methylbutyrate containing oral nutritional supplement (HP-HMB-ONS), on nutritional status, activities of daily living and quality of life (QoL) in old malnourished subjects.MethodsWe conducted an observational, prospective, open label, multicenter study. Participants were > 65 years, undernourished or at nutritional risk [Nutrition Risk Score (NRS) ≥ 3] and had been included on an ONS (HP-HMB-ONS twice daily for 12 weeks) per standard of care. Visits at baseline (V1), 6 weeks (V2) and 12 weeks (V3) were performed. The primary endpoints were gain of body weight, change in body mass index (BMI) and NRS 2002 index. Data from QoL (EQ-5D-3L) and activities of daily living (Katz index) were also collected.ResultsA total of 235 participants were included in the study. Of these 148 took at least a 75% of the HP-HMB-ONS and were included in the analysis (per protocol); median age was 80.0 (SD:8.3) years, 65.5% (n = 97) were female, 67.6% (n = 100) had 2 or more diseases. At V3, a statistically significant increase in weight (2.1 kg; SD: 3.8) (p < 0.001) and BMI (0.8 kg/m2; SD: 1.45) were found compared to V1, whereas NRS 2002 values decreased by 0.9 (SD: 1.2). A significant (p < 0.001) improvement in Katz index (mean change = 0.3; SD:1.4) and EQ-5D scoring (mean change = 0.5; SD:1.9) compared to V1, were also reported.ConclusionsThe results suggest that administration of a HP-HMB-ONS improve the nutritional status and may led to a significant improvement in patients’ activities of daily living and QoL, independent of baseline BMI.

Effects of β‐hydroxy β‐methylbutyrate (HMB) supplementation on muscle mass, function, and other outcomes in patients with cancer: a systematic review

“…Of these, one trial 59 prescribed HMB/Arg/Gln in combination with HMB‐enriched ONS for patients with mild or severe protein‐energy malnutrition. The effects of supplementation with HMB‐enriched ONS alone were also evaluated in two cohort studies 57,58 . Most studies administered HMB supplements orally 49–53,57,58 and two via tube feeding 49,53 .…”

“…Incidence of gastrointestinal adverse events was ≤15%, with two studies reporting a probable relationship between these events and HMB/Arg/Gln supplementation 51,55 . No serious adverse events related to the nutrition intervention were recorded in three studies 51,57,59 . Despite not separating data for each clinical condition, the safety data from de Luis et al 57 was included in this analysis as no patients presented with serious adverse events.…”

“… 44 , 45 Therefore, 15 unique studies involving 943 individuals were included. Studies were conducted in Japan, 46 , 47 , 48 , 49 , 50 Turkey, 51 , 52 , 53 , 54 the USA, 44 , 55 , 56 Spain, 57 , 58 and Italy. 59 …”

“…The effects of supplementation with HMB‐enriched ONS alone were also evaluated in two cohort studies. 57 , 58 Most studies administered HMB supplements orally 49 , 50 , 51 , 52 , 53 , 57 , 58 and two via tube feeding. 49 , 53 A multimodal intervention composed of nutrition plus exercise programme was administered in two studies.…”

“…Absolute number or percentage of adverse events were described in three RCTs 44 , 46 , 55 and seven NRSIs 48 , 49 , 50 , 51 , 53 , 57 , 59 ( Supporting Information S3 ). Incidence of gastrointestinal adverse events was ≤15%, with two studies reporting a probable relationship between these events and HMB/Arg/Gln supplementation.…”