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. 2016 Dec 20;2016(12):CD009840. doi: 10.1002/14651858.CD009840.pub2
  Endpoints quoted in trial document(s)
 (ClinicalTrials.gov, FDA/EMA document, manufacturer's website, published design paper)a Trial results/
 publications available
 in trials register Endpoints quoted in publication(s)b,c Endpoints quoted in abstract of publication(s)b,c
Bouillanne 2013 Source:NCT00135590
Primary outcome measure(s):
  • lean mass (dual energy X‐ray absorptiometry (dexa) and bioelectrical‐impedance analysis (bia)) ‐ time frame: 42 days

No/Yes
(last verified: November 2004)
Primary outcome measure(s):
  • lean mass (total lean soft‐tissue mass (LM) index, appendicular muscle mass (ASMM) index or body cell mass (BCM) index, which is the metabolically active compartment))

Primary outcome measure(s):
  • body composition ((lean mass (LM), appendicular skeletal muscle mass (ASMM), and body cell mass (BCM) indices, measured by X‐ray absorptiometry combined with bioelectrical impedance analysis)

Secondary outcome measure(s):
  • immune functions ‐ time frame: 42 days

  • hand‐grip strength ‐ time frame: 42 days

  • biological nutritional parameters ‐ time frame: 42 days

  • mortality and morbidity (infections and bedsores) ‐ time frame: 42 days

  • ADL ‐ time frame: 42 days

  • plasmatic amino acid levels ‐ time frame: 42 days

Secondary outcome measure(s):
  • hand grip strength

  • ADL score

Secondary outcome measure(s):
  • hand grip strength

  • ADL score

Other outcome measure(s): ‐ Other outcome measure(s):
  • albumin

  • transthyretin

  • C‐reactive protein

  • prognostic inflammatory and nutritional index (PINI)

Other outcome measure(s): ‐
History of changes: 6 documented changes
Faxen‐Irving 2011 Source:NCT01042340
Primary outcome measure(s):
  • to detect a significant difference in energy intake of 48 kj/200 kcal between the groups at 5% significance level and with 80% power ‐ time frame: 5 days to 3 weeks intervention

No/Yes
(last verified: December 2009)
Primary outcome measure(s): ‐ Primary outcome measure(s): ‐
Secondary outcome measure(s):
  • effects on serum lipids and appetite ‐ time frame: 5 days to 3 weeks treatment

Secondary outcome measure(s):
  • acceptance and compliance of the concept by the participants at the ward

Secondary outcome measure(s): ‐
Other outcome measure(s): ‐ Other outcome measure(s):
  • sample size calculation was performed: to detect a significant difference in energy intake of 200 kcal between the groups at 5% significance level and with 80% power, 27 participants in each group were needed. To allow for dropouts this was increased to 35 participants in each group

  • nutritional assessment, by the Nutritional Risk Screening (NRS‐2002) form: evaluation of BMI, weight loss, reduced dietary intake, age 70 and presence of severe illness and a sum score (0‐7 points) was calculated

  • biochemical indicators of nutritional status serum levels of albumin, transthyretin and insulin‐like growth factor‐1 (IGF‐1)

  • C‐reactive protein (CRP)

  • total cholesterol, high‐density lipoprotein (HDL) and low‐density lipoprotein (LDL) cholesterol, fasting serum triglyceride concentrations

  • fatty acid (FA) profiles were measured in serum phospholipids

  • function as determined by ADL according to the Katz ADL index

Other outcome measure(s):
  • food intake and self‐rated appetite

  • Nutritional risk screening (NRS) 2000

  • serum lipids and fatty acid profiles

History of changes: 1 documented change
Holyday 2012 Source:NCT01179321
Primary outcome measure(s): length of stay
No/No
(last verified: March 2006)
Primary outcome measure(s): ‐ Primary outcome measure(s): ‐
Secondary outcome measure(s): ‐ Secondary outcome measure(s): ‐ Secondary outcome measure(s): ‐
Other outcome measure(s): ‐ Other outcome measure(s):
  • pre‐study power analysis based on the average length of stay (LOS) of the trial population (11 d) with 0.80 power using a test with significance of 0.05, would require at least 50 participants in each group to detect a reduction in LOS of 20%

  • the number of participants seen by a clinical dietitian, number of consults per participant and total consultation time per participant was captured from the hospital’s computerised dietitians’ statistics system

  • timeliness of intervention was counted as days between date of admission to the ward and the date seen by the clinical dietitian

  • weight change over the course of admission was calculated from the weight on admission and the weight at discharge

  • deaths during admission

  • number of presentations to emergency and number of hospital readmissions

  • cost of hospital admission, additional costs of a screening and nutritional intervention programme

Other outcome measure(s):
  • length of stay LOS)

  • weight change

  • frequency of readmission to hospital

History of changes: 0 documented changes
Munk 2014 Source:NCT01415635
Primary outcome measure(s):
  • Percentage of participants reaching > 75% of their calculated energy and protein requirements

No/No
(last verified: December 2012)
Primary outcome measure(s):
  • Percentage of participants reaching > 75% of their calculated energy and protein requirements

Primary outcome measure(s):
  • Percentage of participants reaching > 75% of their calculated energy and protein requirements

Secondary outcome measure(s):
  • handgrip strength

  • daily energy and protein intake

  • use of tube feeding

  • use of parenteral nutrition

  • length of stay

  Secondary outcome measure(s):
  • Mean daily energy and protein intake

  • body weight

  • handgrip strength

  • Length of stay

  • number of participants receiving enteral or parenteral feeding

Secondary outcome measure(s):
  • Mean daily energy and protein intake

  • body weight

  • handgrip strength

  • Length of stay

Other outcome measure(s): none provided   Other outcome measure(s): number of participants receiving ONS Other outcome measure(s): ‐
History of changes: 1 documented change
Nijs 2006 Source:NCT00114582
Primary outcome measure:
  • nutritional status, quality of life, physical performance

No/Yes
(last verified: February 2009)
Primary outcome measure(s):
  • quality of life

Primary outcome measure(s): ‐
Secondary outcome measure(s): ‐ Secondary outcome measure(s): ‐ Secondary outcome measure(s): ‐
Other outcome measure(s): ‐ Other outcome measure(s):
  • physical performance

  • body weight

  • energy intake

Other outcome measure(s):
  • quality of life (perceived safety; autonomy; and sensory, physical, and psychosocial functioning)

  • gross and fine motor function

  • body weight

History of changes: 4 documented changes
Salva 2011 Source:NCT00479843
Primary outcome measure(s):
  • evaluation of the effectiveness of the intervention ‐ the main evaluation criteria which would allow the effectiveness of this intervention to be evaluated were the reduction in the loss of autonomy measured by the ADL/iADL scale ‐ time frame: baseline, 6 months, 12 months

No/Yes
(last verified: January 2014)
Primary outcome measure(s): ‐ Primary outcome measure(s):
  • main outcome measure was the reduction in the loss of autonomy ((ADL/IADL) scales) assessed at 6 and 12 months

Secondary outcome measure(s):
  • improvement in the participant's state of nutrition ‐ reducing the burden on carers with the Zarit scale

  • evaluation of the use of healthcare and social resources with the RUD scale

  • improvement of medical practice regarding nutrition


(time frame: baseline, 6 months, 12 months)
Secondary outcome measure(s):
  • improvement in nutritional state of the participant evaluated by their change in weight, BMI and MNA

  • reduction in burden on caregiver (ZARIT scale)

  • reduction in the use of healthcare and social resources (RUD scale)

Secondary outcome measure(s):
  • improvement in nutritional status (Mini Nutritional Assessment (MNA), BMI, and weight changes)

  • caregiver burden (Zarit scale)

Other outcome measure(s): ‐ Other outcome measure(s):
  • our primary hypothesis was that participants in the intervention group would achieve a lower level of dependency compared with participants in the usual care‐control group at 12 months. We considered a significant benefit in the intervention group to be a reduction of 30% in the proportion of participants who lost more than 0.5 points according to the ADL score (loss of autonomy) over one year

Other outcome measure(s)‐
History of changes: 2 documented changes
Van den Berg 2015 Source:NTR2535
Primary outcome measure(s): proportion of participants who received their treatment goal. The treatment goal was to receive at least 75% of the prescribed volume of ONS during admission
No (last verified 19 Nov 2010) Primary outcome measure(s):the percentage of participants who reached the treatment objective of at least 75% of the prescribed volume of ONS during admission Primary outcome measure(s):
The percentage of participants who consumed at least 75% of the prescribed volume of ONS
Secondary outcome measure(s):
intake (mL of ONS) (nurses and food assistants read the amount of ONS left in the bottle)
Secondary outcome measure(s):
Mean intake of ONS per day in mL and energy and protein
Not stated
Other outcome measure(s):‐ Other outcome measure(s): length of hospital stay, hospital readmissions, time to intervention, duration of intervention, mortality Median time of taking ONS
History of changes: No documented changes
'‐' denotes not reported
aTrial document(s) refers to all available information from published design papers and sources other than regular publications (e.g. FDA/EMA documents, manufacturer's websites, trials registers)
 bPublication(s) refers to trial information published in scientific journals (primary reference, duplicate publications, companion documents or multiple reports of a primary trial)
 cOther outcome measures refer to all outcomes not specified as primary or secondary outcome measures
ADL: activities of daily living; BMI: body mass index; EMA: European Medicines Agency; FDA: Food and Drug Administration (US); mo: month(s); N/A: not applicable; N/T: no trial document available; yr: year(s); wk: week(s); ONS oral nutritional supplement