A high-calorie, high-protein, peptide-based oral nutritional supplement (ONS-PBD) improved the nutrition status in patients with gastrointestinal (GI) impairment and malnutrition, according to study results published in Nutrition.
For the analysis, researchers conducted a 12-week, prospective, single arm study, enrolling adult patients with GI impairment from 19 medical sites in Spain. Eligible patients were currently malnourished or at risk for malnutrition due to their GI symptoms. Patient underwent a baseline clinical examination, after which they were instructed to consume a liquid bottled formula of ONS-PBD twice daily for 12 weeks. The primary outcome was compliance with ONS-PBD intake, calculated as the percentage consumed of the total prescribed amount. Secondary endpoints included malnutrition status per the Malnutrition Universal Screening tool and gastrointestinal symptom improvement.
The baseline cohort comprised 90 adult patients of mean age 58.2±18.3 years, among whom 57.8% were men. The most common diagnoses were GI cancer (43.3%), functional GI disorders (18.9%), and Crohn disease (12.2%). A total of 64 patients completed the study. Among these patients, the mean compliance rate at 12 weeks was 78.8±24.5%. The majority of patients (78.1%) reported consuming 60% or more of the prescribed ONS-PBD each day. At 12 weeks, 73.4% of study completers gained or maintained weight compared to baseline. Per MUST scores, the proportion of patients at high risk for malnutrition decreased from 71.1% at baseline to 26.6% at 12 weeks. Patient-reported GI pain levels also decreased significantly over the study period. Health-related quality of life, mobility, activity levels, and anxious/depressive symptoms also improved significantly over the study.
In bivariate analyses, sex and malnutrition level were correlated with ONS-PBD compliance. Specifically, men had greater mean consumption levels compared with women (85.0±3.9% vs 70.3±4.5%; P =.0167). Additionally, patients who were considered severely malnourished at baseline consumed much more of the prescribed supplement than patients who were well-nourished (89.3±5.1% vs 56.1±9.4%; P =.0087). Patients with a cancer diagnosis were less likely to gain or maintain weight over the 12 weeks than patients with other GI disorders (54.2% vs 85.0%; P =.0096).
Results from this study support the feasibility of ONS-PBD use to improve nutritional status in patients with GI impairments. Study limitations included the absence of data on patients’ regular diets and the high drop-out rate, though the latter was often a result of the severity of patient conditions. Further research is necessary to better explore the efficacy of nutritional supplements for specific gastrointestinal conditions, the researchers noted
“The data presented in this study suggest a high level of ONS-PBD compliance in malnourished patients with GI symptoms that leads to a reduction of these symptoms together with an improvement of the subjects’ nutritional status,” the investigators wrote.
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
López-Medina JA, López-Rodriguez C, Estornell-Gualde MA, et al. Relationship between nutritional treatment compliance and nutritional status improvements in patients with gastrointestinal impairment taking an oral-peptide based supplement. Nutrition. Published online May 21, 2022. doi:10.1016/j.nut.2022.111734