Dataset Information

A Nutritionally Complete Oral Nutritional Supplement Powder Improved Nutritional Outcomes in Free-Living Adults at Risk of Malnutrition: A Randomized Controlled Trial.

ABSTRACT:

Background

This randomized controlled trial investigated the effectiveness of an oral nutritional supplement (ONS) on nutrition-related outcomes over 12 weeks in Chinese adults with or at risk of malnutrition.

Methods

88 Chinese adults ≥18 years living independently in Hong Kong with Mini Nutritional Assessment-Short Form (MNA-SF) score ≤11 were randomly assigned to (1) 2 servings/day of nutritionally complete ONS powder made with water (Fresubin^® Powder (Fresubin Kabi Deutschland GmbH, Bad Homburg, Germany), 600 kcal, 22.4 g protein) for 12 weeks (intervention group) or (2) no treatment (control group). The primary outcome was increase in body weight (BW) over 12 weeks. Secondary outcomes included improvement in body mass index (BMI), mid-arm circumference (MAC), calf circumference, MNA-SF score, quality of life, self-rated health, frailty, and diet quality.

Results

The intervention group showed a significantly higher mean increase in BW compared with the control group (1.381 kg, intervention vs control, p < 0.001). The intervention group also showed significantly higher mean increases in BMI, MAC, calf circumference, intake of energy, protein, vitamin D, and calcium compared with the control group. No group differences in the changes of other outcomes were observed.

Conclusions

For Chinese free-living adults at risk of malnutrition, daily consumption of a nutritionally complete ONS powder improved nutritional outcomes compared with the control group.

SUBMITTER: Yeung SSY

PROVIDER: S-EPMC9517313 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature

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Publications

A Nutritionally Complete Oral Nutritional Supplement Powder Improved Nutritional Outcomes in Free-Living Adults at Risk of Malnutrition: A Randomized Controlled Trial.

Yeung Suey S Y SSY Lee Jenny S W JSW Kwok Timothy T

International journal of environmental research and public health 20220909 18

<h4>Background</h4>This randomized controlled trial investigated the effectiveness of an oral nutritional supplement (ONS) on nutrition-related outcomes over 12 weeks in Chinese adults with or at risk of malnutrition.<h4>Methods</h4>88 Chinese adults ≥18 years living independently in Hong Kong with Mini Nutritional Assessment-Short Form (MNA-SF) score ≤11 were randomly assigned to (1) 2 servings/day of nutritionally complete ONS powder made with water (Fresubin<sup>®</sup> Powder (Fresubin Kabi ...[more]

PMID: 36141627

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Project description:BackgroundThe global aging population is expanding rapidly and many individuals have a particularly higher risk of malnutrition. Malnutrition can lead to impaired body function, morbidity, and mortality. Meeting nutritional requirements is a key strategy to minimize multiple debilitating adverse outcomes associated with malnutrition in the elderly. Oral nutritional supplements (ONS) have been widely used as a dietary intervention for malnutrition in older adults. These supplements provide additional nutrients and calories to support nutritional requirements and have been shown to improve nutritional status, physical function, and quality of life in malnourished older adults.MethodsThis is an open-label, randomized controlled, parallel-group study including 50 institutionalized older adults (aged > 60 years) with malnutrition or at risk of malnutrition, living in a selected elderly care institution in Colombo, Sri Lanka. The aim is to assess improvement in healthy body weight gain and body composition in older adults with malnutrition at risk of malnutrition by using an ONS. Older adults will be screened for malnutrition using the Mini Nutrition Assessment (MNA) tool and eligible participants randomized using the simple random sampling technique to intervention and control groups (1:1 allocation ratio). The intervention group will consume 200 mL of ONS before bed continuously for 12 weeks. The primary outcome is the percentage who achieved at least 5% weight gain in the intervention group compared to the control group. Nutritional status (anthropometric, biochemical, clinical, and dietary), body composition (dual-energy X-ray absorptiometry), frailty, functional capacity (hand grip strength, knee extension, and Barthel index) cognitive status (Montreal Cognitive Assessment), and physical activity will be assessed as secondary outcomes at baseline and at the end of the 12-week intervention. Some measurements (anthropometry, dietary, and functional assessments) will also be performed at the end of the 4th week. Data will be analyzed using SPSS V-23.DiscussionThis study will determine whether the use of an ONS is effective in promoting healthy weight gain in older adults with malnutrition or at risk of malnutrition. In addition, investigating the impact of an ONS on multiple outcomes via clinical, nutritional, functional, and cognitive function will provide a more comprehensive understanding of the potential benefits of these supplements.Trial registrationSri Lanka Clinical Trail Registry SLCTR/2022/021. Oct. 6, 2022.

Project description:IntroductionPatient compliance with oral nutritional supplements (ONS) is not optimal for meeting energy and nutritional requirements in a high proportion of patients with disease-related malnutrition (DRM). Energy density or prescribed volume of ONS may impact compliance.MethodsA randomized, open-label crossover trial was conducted in outpatients with DRM to compare compliance with a high energy-dense ONS (edONS, 2.4 kcal/mL) and a reference ONS (heONS, 2.0 kcal/mL; NCT05609006). Patients were randomly assigned to two 8-week treatment sequences of four-weeks periods: edONS + heONS (sequence A) or heONS + edONS (sequence B). Patients daily reported the amount of product left over gastrointestinal tolerance and satisfaction with ONS. A non-inferiority analysis was performed to compare the compliance rate (percentage of consumed energy over the prescribed) for each period and sequence.ResultsFifty-three patients were assigned to sequence A and 50 to sequence B (55.7 ± 13.9 years, 37.0% female, 67.1% oncology patients). In sequence A, the compliance rates were 88.6% ± 14.3% vs. 84.1 ± 21.8% (p = 0.183), while in sequence B, they were 78.9% ± 23.8% vs. 84.4% ± 21.4% (p < 0.01). In both sequences, the lower range of the confidence interval for compliance with edONS was greater than the non-inferiority threshold (for sequence A ΔCompA was 4.5% [95% CI, -2.0% to 10.0%], and for sequence, B ΔCompB was 5.6% [95% CI, -3.0% to 14.0%]). The total discarded cost for each ONS was higher for heONS than edONS, being the difference statistically significant in sequence B. BMI increased slightly and not significantly in both sequences, and the percentage of patients with severe malnutrition was reduced. The frequency of gastrointestinal symptoms was low for both sequences, and satisfaction with ONS was slightly higher for edONS.ConclusionOur 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.

Project description:BackgroundSmall randomized trials of early postoperative oral nutritional supplementation (ONS) suggest various health benefits following colorectal surgery (CRS). However, real-world evidence of the impact of early ONS on clinical outcomes in CRS is lacking.MethodsUsing a nationwide administrative-financial database (Premier Healthcare Database), we examined the association between early ONS use and postoperative clinical outcomes in patients undergoing elective open or laparoscopic CRS between 2008 and 2014. Early ONS was defined as the presence of charges for ONS before postoperative day (POD) 3. The primary outcome was composite infectious complications. Key secondary efficacy (intensive care unit (ICU) admission and gastrointestinal complications) and falsification (blood transfusion and myocardial infarction) outcomes were also examined. Propensity score matching was used to assemble patient groups that were comparable at baseline, and differences in outcomes were examined.ResultsOverall, patients receiving early ONS were older with greater comorbidities and more likely to be Medicare beneficiaries with malnutrition. In a well-matched sample of early ONS recipients (n = 267) versus non-recipients (n = 534), infectious complications were significantly lower in early ONS recipients (6.7% vs. 11.8%, P < 0.03). Early ONS use was also associated with significantly reduced rates of pneumonia (P < 0.04), ICU admissions (P < 0.04), and gastrointestinal complications (P < 0.05). There were no significant differences in falsification outcomes.ConclusionsAlthough early postoperative ONS after CRS was more likely to be utilized in elderly patients with greater comorbidities, the use of early ONS was associated with reduced infectious complications, pneumonia, ICU admission, and gastrointestinal complications. This propensity score-matched study using real-world data suggests that clinical outcomes are improved with early ONS use, a simple and inexpensive intervention in CRS patients.

Dataset Information

A Nutritionally Complete Oral Nutritional Supplement Powder Improved Nutritional Outcomes in Free-Living Adults at Risk of Malnutrition: A Randomized Controlled Trial.

Background

Methods

Results

Conclusions

Publications

A Nutritionally Complete Oral Nutritional Supplement Powder Improved Nutritional Outcomes in Free-Living Adults at Risk of Malnutrition: A Randomized Controlled Trial.

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