| Parsons et al. (2016)1 |
Randomised, parallel, open-label trial |
Adults aged >50y at risk of malnutrition (Care homes) |
ONS ad libitum (range of styles, flavours, volume, energy density; 87% took ONS with energy density between 1.5-2.4kcal/ ml). Target provision 600kcal and 16g protein daily. ONS group also seen by dietitian (53) |
Dietary advice by dietitian with leaflet at baseline and at week 6 (51) |
12 weeks |
- Significantly higher scores in two out of the three QoL measures in intervention vs. control (EQ-5D TTO p = 0.005, VASr p = 0.006) in ITT analysis and significantly higher scores in all measures in intervention vs. control in per protocol analysis (EQ-5D TTO p = 0.002, VASr p = 0.004, Visual Analogue Scale p = 0.027) at 12 weeks.
- Responses to questions about appetite sensations did not differ between groups at any time points except for “fullness” which was experienced in a smaller proportion of subjects in the intervention vs. control group at week 12 (41% vs 70%; p < 0.05).
|
| Grootwagers et al, (2021)2 |
Randomised, open-label, standard-care controlled trial |
Older Adults aged >65y at risk of malnutrition (Care homes) |
12 weeks of a novel oral nutritional supplement (ONS) |
Standard care without ONS |
12 weeks |
- Both groups experienced significant increases in total body mass.
- No significant changes in lean body mass were observed within or between the groups.
- Fat mass increased significantly more in the standard supplement group compared to the novel supplement group (time × treatment effect P = 0.045).
- The novel supplement group showed greater improvements in walking performance:
- 4-meter walk (treatment × time interaction P = 0.048)
- 400-meter walk (treatment × time interaction P = 0.038)
- Gene sets related to mitochondrial function and oxidative phosphorylation were:
- Upregulated in the novel supplement group
- Downregulated in the standard supplement group
|
| Ng et al. (2015)3 |
RCT – 5 arms (49 ONS, 50 cognitive, 48 physical, 49 combination, 50 control) |
Frail older people, ≥ 65 y, able to ambulate without personal assistance, identified door-to door using cardiovascular health study (CHS) criteria for frailty (Community- free-living) |
ONS, (49) ONS with exercise and cognitive training (49) |
Usual care (50), Placebos identical in appearance to ONS and vitamin/mineral supplements. Artificially sweetened vanilla flavoured liquid made with water and non-dairy creamer |
24 weeks/
6 months |
- Significant reductions in frailty scores were seen in all groups 12 month follow up compared with baseline and control groups- nutritional (odds ratio (OR) 2.98), cognition (OR 2.89), physical (OR 4.05) and combination (OR 5.00) for intervention groups.
- Significant increase in levels of physical activity also seen in the nutritional intervention arm compared with baseline p <0.01 vs control at 6 and 12 months.
|
| Huynh et al. (2014)4 |
RCT- 2 arm |
Moderate and severely malnourished patients (Hospitals) |
ONS + DC (104) |
Standard diet + DC (103) |
12 weeks |
- Patients who were in the lowest tertile at baseline for handgrip strength score in the ONS group had a greater improvement at week 4 (p = 0.042) compared to the control group.
|
| Malaforina et al. (2021)5 |
Multicenter, prospective, observational, pragmatic study |
38 skilled nursing homes across Spain |
High-protein, high-calorie ONS |
|
12 weeks |
- Handgrip Strength: Significant improvements observed across all BMI categories
- Functional Status: Enhancements in Barthel Index, gait speed, and Short Physical Performance Battery (SPPB) scores
- Nutritional Status: Positive correlations between weight gain and functional improvements
- Adherence and Safety: High adherence (94.6%) with good tolerability and no major complications reported
|
| Kim and Lee (2012)6 |
RCT – 2 arms |
Frail older people, ≥ 65 y, low socioeconomic status (Community- free-living) |
ONS + DC? (43) |
Visited monthly – no placebo ONS/ counselling but a small gift given. Home healthcare services suspended during trial period (44) |
12 weeks |
- Short physical battery remained stable in the intervention group while decreasing by 12.5% in controls (p = 0.039).
- Usual gait speed decreased by 1.0% in the intervention group and decreased by 12.5% in controls (p = 0.039).
- Timed up and go improved by 7.2% in the intervention group but decreased by 3.4% in controls (p = 0.038)
|
| Neelemaat et al. (2012)7 |
RCT |
Malnourished elderly (> 60 years) patients, various conditions. (Community – post hospital discharge) |
ONS (105) |
Usual care (105) |
3 months |
- Significant decrease in functional limitations (mean difference -0.72, 95% CI -1.15 to -0.28) with no difference in costs
|
| Feldblum et al. (2011)8 |
RCT- 3 arm |
Older medical patients
(hospital + follow-up post discharge) |
Individualised
DC + ONS in hospital and post discharge (78) |
Individualised
DC + ONS in hospital (73)
Routine care (108) |
6 months |
- Significantly lower mortality in group 1 (3.8%) vs groups 2 and 3 (11.6%, p = 0.046). No significant differences in other functional cognitive parameters
|
| Rufenacht et al. (2010)9 |
RT |
Undernourished patients (hospital) |
Individualised DC + ONS (18)
ONS (18) |
|
10-15 days |
- Both groups demonstrated improved QOL parameters from baseline to discharge (NT group p < 0.001, ONS group p < 0.003). No significant differences between groups. NT group showed further significant improvement in QOL 2 months post discharge (p = 0.016)
|
| McMurdo et al. (2009)10 |
RCT |
Older people, malnourished. (Community-dwelling, admitted to hospital with acute illness. Residents of care homes excluded. ONS provided upon discharge) |
ONS (126) |
Control supplement (127) |
4 months |
- Significant improvement in hand-grip strength in ONS group compared with controls
- Significantly more vector movement (objective measure of physical activity using accelerometry) in the ONS group compared with controls
|
| Matheson et al. (2021)11 |
Double-blind, randomised, placebo-controlled trial (NOURISH study) |
Older adults (≥65 years) hospitalised for cardiovascular or pulmonary events (e.g., congestive heart failure, acute myocardial infarction, pneumonia, COPD exacerbation) and identified as malnourished using the Subjective Global Assessment (SGA) |
Participants received standard care plus a specialised high-protein ONS containing β-hydroxy-β-methylbutyrate (HMB), administered twice daily during hospitalisation and for 90 days post-discharge |
Placebo supplement alongside standard care |
90 days post hospital discharge |
- The intervention group exhibited significantly higher HGS compared to the placebo group across all post-discharge time points (e.g., at day 90: 23.25 ± 0.25 kg vs. 22.63 ± 0.25 kg; p = 0.043).
- A significant positive association was found between HGS and nutritional status (SGA) improvements. 49% of participants with increased HGS from discharge had improved nutritional status versus 31% with unchanged or decreased HGS (p = 0.003). HGS and the scores on the Katz index of independence in activities of daily living (ADL) were positively associated at all visits, including all ITT subjects (Pearson’s r range: 0.24 to 0.34, all p < 0.0001).
|
| Chew et al. (2021)12 |
Randomised, controlled trial |
Community-dwelling older adults in Singapore 811 adults aged ≥65 years at medium or high risk of malnutrition (per MUST) |
Daily intake of 2 servings of oral nutritional supplement (ONS) containing HMB + dietary counselling |
2 servings/day of placebo supplement + dietary counselling |
180 days |
- Primary Outcome: Achieved by 33.4% in the intervention group vs. 8.7% in placebo (P < 0.001), driven mainly by weight gain (36.2% vs. 9.4%, P < 0.001)
- Body Composition: Significant improvements in weight, BMI, and mid-upper arm circumference in the intervention group at days 30, 90, and 180 (all P < 0.05)
- Nutritional Status: Better outcomes in intervention group (MUST risk OR = 2.68; vitamin D status OR = 4.23; both P < 0.001)
- Dietary Intake: Higher energy, protein, fat, and carbohydrate intake in the intervention group (all P ≤ 0.017)
- Functional Outcomes:
- Leg Strength: Significantly higher at day 90 (P = 0.030)
- Handgrip Strength: Higher in females at day 180 (P = 0.048)
- Calf Circumference: Greater in low-appendicular skeletal muscle index (ASMI) subgroup at days 90 and 180 (both P ≤ 0.0289)
|
| Norman et al. (2008)13 |
RCT |
Adult malnourished SGA B or C, benign GI disease (post hospital) |
HP ONS + DC (38) |
DC (42) |
3 months |
- Significant improvement in hand-grip strength and peak expiratory flow in ONS group, unchanged in DC group
- Significant improvement in all 8 scales of QOL in ONS group, whereas improvement in 3 scales in DC group only. Significantly higher increases in physical functioning, role physical, vitality and general health scales in ONS group
- Change in hand-grip strength correlated with the change in 2 physical scales (physical functioning and physical role)
|
| Sim et al. (2022)14 |
Randomised controlled trial |
Adult GI cancer patients |
200 mL of omega-3 enriched oral nutritional supplements (ONS), twice daily |
Routine care (no ONS) |
8 weeks |
- Nutritional status: Significant improvement in PG-SGA scores in the intervention group (p < 0.01)
- Quality of life:
- Physical and role functioning declined only in the control group (role functioning p < 0.001)
- Fatigue scores significantly improved in the intervention group (p < 0.02)
|
| Meng et al. (2021)15 |
Randomised controlled trial |
Adult patients’ post-gastrectomy nutritional risk NRS-2002 ≥3 |
ONS (~370 mL/day) + dietary advice for 3 months |
Dietary advice alone |
8 weeks |
- Primary Outcomes:
- Less weight loss, higher BMI, and higher skeletal muscle index (SMI) in the ONS group (p < 0.05)
- Lower incidence of sarcopenia in the ONS group (p < 0.05)
- Secondary Outcomes:
- Fewer chemotherapy modifications (delay, dose reduction, termination; p <0.05)
- No difference in 90-day readmission rate
- Better QOL: less fatigue and appetite loss
|
| Rabadi et al. (2008)16 |
RDB Trial |
Undernourished (2.5% weight loss in 2 weeks) (patients admitted to a stroke rehabilitation unit) |
Intensive ONS |
Standard ONS |
From within 72 hours of arrival on unit to discharge |
- Significant improvement in the Intensive ONS group in total FIM score, FIM motor sub-score, 2-minute walk and 6-minute walk
|
| Gariballa & Forster (2007)17 |
RDBP± CT |
Acutely ill older people (hospital and post discharge) |
NHD + HP ONS (106) |
NHD + placebo (119) |
6 weeks |
- Significant increase in number of patients with no symptoms of depression and decrease in those with symptoms of mild or severe depression among ONS group compared with placebo group
|
| Gariballa & Forster (2007)18 |
RDBP± CT |
Acutely ill older people (hospital and post discharge) |
NHD + HP ONS (106) |
NHD + placebo (119) |
6 weeks |
- Significantly better QOL scores in the ONS group compared with placebo group at 6 months but not at 6 weeks. Effect of supplementation was seen in higher physical function, role physical and social function scores
|
| Persson et al. (2007)19 |
RCT |
Older acutely ill/trauma patients at risk of malnutrition MNA-SF (on hospital discharge to home/nursing home) |
ONS + DC (29) |
Brief written DA (25) |
4 months |
- Treated-as-protocol analyses showed Katz ADL index improved in the ONS + DC group
|
| Price et al. (2005)20 |
RCT |
Undernourished* older people (on hospital discharge to community) |
ONS (70) |
Usual care (66) |
8 weeks |
- Improvement in hand-grip strength in both groups, but ONS group showed significantly greater increase over 12 weeks compared with controls Intention-to-treat analysis showed a 13.9% increase in the ONS group compared with 7.2% in the control group
|
| Edington et al. (2004)21 |
RCT |
Older malnourished** patients (community) |
ONS (51) |
Standard care (49) |
8 weeks |
- Significant improvement in hand-grip strength during supplementation but not sustained from week 8 to week 24
- No difference between groups in QOL utility score or health status; however, ONS group scored significantly higher on the mobility score at week 24 than controls, possibly indicating an improvement in strength
|
| Payette et al. (2002)22 |
RCT |
Frail older people at high nutritional risk (community)*** |
ONS + DC (41) |
Visited monthly, no advice/ONS (42) |
16 weeks |
- When results analysed by gender, significant reduction in the meantime to execute ‘up and go’ test was seen in women in the ONS group, and knee extensor strength increased in men in the ONS group
- The number of days subjects had to stay in bed significantly increased in the control group over the course of the study compared with baseline; in contrast, no change in bed disability days seen in the ONS group
|
