Effect of a New High-protein Oral Supplement on Functional Parameters in Patients in Nursing Homes (PRESAGE-T2)

• ClinicalTrials.gov Identifier: NCT02117609
• Recruitment Status: Completed
• First Posted: April 21, 2014
• Last Update Posted: October 7, 2015
• Sponsor: Lactalis
• Collaborators: University Hospital, Toulouse; University of Lille Nord de France; National Research Agency, France
• Information provided by (Responsible Party): Lactalis

Tracking Information

• First Submitted Date: April 16, 2014
• First Posted Date: April 21, 2014
• Last Update Posted Date: October 7, 2015
• Study Start Date: May 2012
• Actual Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 17, 2014): Change from baseline in 4-meter walking speed [ Time Frame: After 3 months and 6 months ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 17, 2014)

• Change from baseline in grip strength [ Time Frame: After 3 months and 6 months ]
• Change from baseline in ADL (Activities Daily Living) score [ Time Frame: After 3 months and 6 months ]
• Change from baseline in Geriatric Depression Scale [ Time Frame: After 3 months and 6 months ]
• Change from baseline in quality of life (QOL-AD) [ Time Frame: After 3 months and 6 months ]
• Frequency of pathologic adverse events (disease, acute infection, falls, hospitalization) [ Time Frame: During the 3 months and/or 6 months of consumption ]
• Change from baseline in body composition measured by bioelectrical impedence analysis (BIA) [ Time Frame: After 3 months and 6 months ]
• Change from baseline in nutritional status (Mini Nutritional Assessment) [ Time Frame: After 3 months and 6 months ]
• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of a New High-protein Oral Supplement on Functional Parameters in Patients in Nursing Homes
• Official 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
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Supportive Care
• Condition: Malnutrition

Intervention

• Dietary Supplement: New DELICAL formula
  3 months with the option of continuing until 6 months.
• Dietary Supplement: Standard DELICAL formula
  3 months with the option of continuing until 6 months.

Study Arms

• Experimental: New DELICAL formula
  New high-protein oral nutrient supplement
  Intervention: Dietary Supplement: New DELICAL formula
• Active Comparator: Standard DELICAL formula
  Standard isoenergetic isoprotein formula
  Intervention: Dietary Supplement: Standard DELICAL formula

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 17, 2014): 110
• Original Estimated Enrollment: Same as current
• Study Completion Date: Not Provided
• Actual Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 60 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT02117609
• Other Study ID Numbers: LRD-2011-PRESAGE; ANR ALIA2010-01306 Presage ( Other Grant/Funding Number: National Research Organization, France )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Lactalis
• Original Responsible Party: Same as current
• Current Study Sponsor: Lactalis
• Original Study Sponsor: Same as current

Collaborators

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

Investigators

• Principal Investigator: Yves Rolland, Pr; University Hospital, Toulouse
• Study Director: Cécile Bonhomme, PhD; Lactalis Nutrition Santé
• Study Chair: David Seguy, Dr; U995, Université Lille Nord France
• Study Chair: Charlotte Baudry, PhD; Lactalis Recherche et Développement

• PRS Account: Lactalis
• Verification Date: October 2015