Ignite Creation Date:
2024-05-06 @ 7:00 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05853874
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-05-11
First Post:
2023-04-26
Brief Title:
Development of Sustainable Eating Pattern to Limit Malnutrition in Older Adults
Sponsor:
University of Pavia
Organization:
University of Pavia
Study Overview
Official Title:
Sustainable Eating Pattern to Limit Malnutrition in Older Adults
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SENIOR
Brief Summary:
The SENIOR STUDY is aimed at improving the condition of older adults and malnutrition management in and out Italian hospital settings since malnutrition is highly prevalent clinically relevant and potentially treatable conditions This study consist of two phases an initial cross-sectional phase and a secondary nutritional intervention phase RCT
The SENIOR RCT aim to evaluate the efficacy of a 6 months nutrition protocol intervention compared to hospital standard care on malnourished older adults Physical and nutritional status will be evaluated through anthropometric measures blood exams and physical performance In addition the individual health perception will be evaluated
It is expected to find an improvements of the physical and nutritional status
The SENIOR RCT aim to evaluate the efficacy of a 6 months nutrition protocol intervention compared to hospital standard care on malnourished older adults Physical and nutritional status will be evaluated through anthropometric measures blood exams and physical performance In addition the individual health perception will be evaluated
It is expected to find an improvements of the physical and nutritional status
Detailed Description:
The SENIOR RCT is a multicenter study conducted in two North Italian Scientific Hospitalization and Treatment Institution in Pavia on older malnourished adults 65 years old The estimated duration is 24 months which include 6 months of nutritional intervention and a follow-up after 6 months with an preferred starting date on January 2024
The primary objective of the SENIOR RCT is the evaluation of the efficacy of a 6 months sustainable nutrition protocol on malnourished older adults participants diagnosed with the most recent GLIM criteria in comparison to the hospital standard of care
Therefore the primary endpoint is the improvement of the nutritional status between pre- and post-intervention between experimental and control group measuring the change of body weight and strength handgrip
Secondary objectives are the change pre- and post-intervention between experimental and control group for blood biomarkers dietary habits quality of life and evaluation of sarcopenia
Secondary endpoints are the change pre- and post-intervention between experimental and control group for blood biomarkers MEDI-LITE score SF-12 diet composition phase angle and gait speed
Participants of this study are older adults over 65 previously enrolled in the SENIOR cross-sectional study and willing to participate to the RCT phase or new enrolled patients from the two hospitals in according to the eligible criteria Malnutrition will be diagnosed according to GLIM criteria using Malnutrition Universal Screening Tool MUST as screening tool
The experimental group at the baseline will receive a nutritional assessment followed by the elaboration of a sustainable and personalized nutritional protocol by qualified dietitians The intervention will last 6 months with a monthly evaluation of the dietary consumption of the previous 24 hour recall-24h followed by a final follow-up after additional 6 months
For both groups at the baseline will be measured blood biomarkers anthropometric variables Mediterranean diet adherence quality of life strength handgrip and locomotion gait speed At 3 months weight and strength will be evaluated At 6- and 12-months baseline measurements will be repeated except for the nutritional assessment
Dietary habits will be evaluated through a Mediterranean diet questionnaire MEDI-LITE while quality of life will be measured with Short-Form Health Survey SF-12 questionnaire Anthropometric variables include weight height knee height and demi-span waist circumference and body composition BIA In addition strength handgrip and locomotion gait speed will be evaluated Strength handgrip Appendicular Skeletal Mass ASM and locomotion gait speed are necessary to diagnose sarcopenia according to the European Working Group on Sarcopenia in Older People 2 EWGSOP2 consensus Malnutrition will be evaluated again at 6 months
Blood analysis will be carried out on a subgroup to evaluate the participants inflammatory nutritional and clinical status
The primary objective of the SENIOR RCT is the evaluation of the efficacy of a 6 months sustainable nutrition protocol on malnourished older adults participants diagnosed with the most recent GLIM criteria in comparison to the hospital standard of care
Therefore the primary endpoint is the improvement of the nutritional status between pre- and post-intervention between experimental and control group measuring the change of body weight and strength handgrip
Secondary objectives are the change pre- and post-intervention between experimental and control group for blood biomarkers dietary habits quality of life and evaluation of sarcopenia
Secondary endpoints are the change pre- and post-intervention between experimental and control group for blood biomarkers MEDI-LITE score SF-12 diet composition phase angle and gait speed
Participants of this study are older adults over 65 previously enrolled in the SENIOR cross-sectional study and willing to participate to the RCT phase or new enrolled patients from the two hospitals in according to the eligible criteria Malnutrition will be diagnosed according to GLIM criteria using Malnutrition Universal Screening Tool MUST as screening tool
The experimental group at the baseline will receive a nutritional assessment followed by the elaboration of a sustainable and personalized nutritional protocol by qualified dietitians The intervention will last 6 months with a monthly evaluation of the dietary consumption of the previous 24 hour recall-24h followed by a final follow-up after additional 6 months
For both groups at the baseline will be measured blood biomarkers anthropometric variables Mediterranean diet adherence quality of life strength handgrip and locomotion gait speed At 3 months weight and strength will be evaluated At 6- and 12-months baseline measurements will be repeated except for the nutritional assessment
Dietary habits will be evaluated through a Mediterranean diet questionnaire MEDI-LITE while quality of life will be measured with Short-Form Health Survey SF-12 questionnaire Anthropometric variables include weight height knee height and demi-span waist circumference and body composition BIA In addition strength handgrip and locomotion gait speed will be evaluated Strength handgrip Appendicular Skeletal Mass ASM and locomotion gait speed are necessary to diagnose sarcopenia according to the European Working Group on Sarcopenia in Older People 2 EWGSOP2 consensus Malnutrition will be evaluated again at 6 months
Blood analysis will be carried out on a subgroup to evaluate the participants inflammatory nutritional and clinical status
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CUP F13C22001210007 | OTHER_GRANT | PNRR - MUR | None |