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Completed

NCT Number: NCT02117609

Effect of a New High-protein Oral Supplement on Functional Parameters in Patients in Nursing Homes

The objective of this study is to determine whether a supplementation with a new high-protein oral supplement can improve the evolution of functional parameters in elderly patients in nursing homes.

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Key information

Conditions

Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nursing homes - Région Midi-Pyrénées

Toulouse, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Man or woman aged more than 60 years old
  • Living in a nursing home for at least 2 months
  • Malnourished or at risk of malnutrition (MNA<23.5 or BMI<24 or albumin<35 g/l or weight loss of more than 5 kg in the last 6 months)
  • Without dementia or with moderate dementia (MMSE > or =10/30)
  • Able to walk without human assistance (technical assistance allowed)
  • No vitamin D supplementation
  • Able to follow the study procedures and agreed to consume oral supplement

Exclusion criteria

  • Severe dementia (MMSE < 10/30)
  • Enteral nutrition
  • Severe renal or hepatic impairment
  • Cancer with chemotherapy
  • Uncontrolled diabetes
  • Lactose intolerance
  • Cow's milk protein allergy

Treatment and study plan

New DELICAL formula

Dietary Supplement

3 months with the option of continuing until 6 months.

Standard DELICAL formula

Dietary Supplement

3 months with the option of continuing until 6 months.

Primary outcomes

  1. Change from baseline in 4-meter walking speed

    Time frame: After 3 months and 6 months

Secondary outcomes

  1. Change from baseline in grip strength

    Time frame: After 3 months and 6 months

  2. Change from baseline in ADL (Activities Daily Living) score

    Time frame: After 3 months and 6 months

  3. Change from baseline in Geriatric Depression Scale

    Time frame: After 3 months and 6 months

  4. Change from baseline in quality of life (QOL-AD)

    Time frame: After 3 months and 6 months

  5. Frequency of pathologic adverse events (disease, acute infection, falls, hospitalization)

    Time frame: During the 3 months and/or 6 months of consumption

  6. Change from baseline in body composition measured by bioelectrical impedence analysis (BIA)

    Time frame: After 3 months and 6 months

  7. Change from baseline in nutritional status (Mini Nutritional Assessment)

    Time frame: After 3 months and 6 months

  8. Changes from baseline in blood parameters

    Time frame: After 3 months and 6 months

    Inflammation markers (TNFalpha, TNF-R1, TNF-R2, IL 15), Fatty acid composition of red blood cell membranes, Fibrinogen, CRP, albumin, prealbumin, orosomucoid, IGF-1, cystein, glutathione peroxidase, oxidized and reduced glutathione

Sponsors and collaborators

Lead sponsor

Lactalis

Industry

Collaborators

  • National Research Agency, France
  • University Hospital, Toulouse
  • University of Lille Nord de France

Registry information

Official study title

Effet d'Une supplémentation Avec Une Nouvelle préparation hyperprotéinée et Hypercalorique Sur l'évolution Des paramètres Fonctionnels, Nutritionnels et Cognitifs Chez la Personne âgée en Institution

Acronym: PRESAGE-T2

Important dates

Study start
2012
Primary completion
2015
First posted
Apr 21, 2014
Registry last updated
Oct 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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