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Oral nutritional supplements and dietary advice versus dietary advice alone on clinical outcomes in malnourished community dwelling individuals

A randomised trial of oral nutritional supplements and dietary advice versus dietary advice alone on clinical outcomes in malnourished community dwelling individuals

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN26004104
Enrollment
300
Registered
2012-10-05
Start date
2012-12-14
Completion date
Unknown
Last updated
2019-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malnutrition in the elderly Nutritional, Metabolic, Endocrine

Interventions

1. Dietary Advice: Dietary Advice written information 2. Oral Nutritional Supplements + Dietary Advice Follow Up Length: 12 month(s)

Sponsors

Southampton University Hospitals NHS Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Male or female 2. Age > 50 years 3. Disease-related malnutrition using Malnutrition Universal Screening Tool (MUST) 4. Malnutrition caused by disease/clinical condition 5. Competent to provide written informed consent and able to answer questions 6. Able to eat and drink 7. Willingness to take part in the trial and to follow the trial protocol

Exclusion criteria

Exclusion criteria: 1. Galactosemia or known lactose intolerance 2. Currently receiving (or likely to receive in next 12 weeks) nutritional support including dietary advice, oral nutritional supplements, tube or parenteral nutrition 3. Chronic renal disease requiring dialysis 4. Dysphagia 5. Poorly controlled diabetes 6. Liver failure 7. Cancer 8. Palliative / end of life care 9. Active malignancy / active cancer treatment / palliative care 10. Malnutrition as a result of social factors e.g. unable to purchase food 11. Currently residing in an institution to receive care e.g. care home 12. Participation in other clinical trials

Design outcomes

Primary

MeasureTime frame
Quality of Life (QOL) at baseline (BL), wk 4,8,12, 6 months and optional 12 months

Secondary

MeasureTime frame
1. Acceptability and complicance at BL, weeks 4, 8, 12 2. Clinical / Functional at BL, weeks 4, 8, 12, 6 months and optional 12 months 3. Intake at BL, weeks 4,8,12, 6 months and optional 12 months 4. Resource Use at BL, weeks 4, 8, 12, 6 months, optional 12 months 5. Weight at BL, weeks 4, 8, 12, 6 months and optional 12 months

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026