Huynh 2015.
Methods | Randomised clinical trial, India | |
Participants | 212 hospitalised adults admitted within 36 hours to either the medical or the surgical wards, and who were diagnosed with moderate or severe malnutrition based on the modified Subjective Global Assessment were eligible for inclusion. The participants were at nutritional risk due to being malnourished according to SGA. Male:Female = 115:92 (5 participants not included in this assessment) Mean age = 40 years Exclusion criteria: being less than 6 weeks post‐partum,active tuberculosis, acute hepatitis B or C, or HIV, diabetes type I and II, dementia, brain metastases, active malignancy, severe renal or liver failure, burn injury covering ≥ 15% of the body, clinically significant ascites, severe oedema, eating disorders or psychological conditions that might interfere with dietary intake, severe nausea, dysphagia, vomiting, active gastritis and gastrointestinal bleeding. Other exclusion criteria included taking progestational agents, steroids and growth hormone. |
|
Interventions | Experimental group: 2 servings of ONS a day for 12 weeks. The ONS was a commercially‐available powder product (Ensure; Abbott Healthcare Private Limited, Mumbai, India). For this study, the ONS was packaged in single serving sachets (53 g each) and labelled as clinical study product. When given twice daily, the ONS provided 432 kcal, 16 g of high‐quality protein, 60 g of carbohydrate, 14 g of fat and 28 micronutrients. (n = 106)
Control group: No intervention (n = 106) Co‐interventions: 3 sessions of dietary counselling administered at baseline, weeks 4 and 8. During the hospital stay, participants from both groups consumed hospital‐prepared foods as prescribed by the dietitians. |
|
Outcomes | Weight, BMI, modified SGA score, pre‐albumin, albumin, haemoglobin, total protein and C‐reactive protein, changes in dietary intake and functionality using hand‐grip strength | |
Study dates | Not stated | |
Notes | The participants started the intervention during hospitalisation but received some of the intervention as outpatients. We only used the assessment at 4 weeks, due to the nature of the intervention. We contacted the author on 08th February 2016 by email: dieu.huynh@abbott.com. We received an initial reply but no further information. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation was performed using SAS. |
Allocation concealment (selection bias) | Low risk | The envelopes were described as sealed and opaque. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | The oral supplements were labelled as study supplement. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described |
Incomplete outcome data (attrition bias) All outcomes | High risk | There were > 5% dropouts and the trial did not use proper methodology to account for the missing data for participants. |
Selective reporting (reporting bias) | Low risk | The trial reported the outcomes in the pre‐published protocol (NCT01641770). |
For‐profit bias | High risk | |
Other bias | Low risk |