Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06353984
Status:
RECRUITING
Last Update Posted:
2024-04-09
First Post:
2024-02-28
Brief Title:
Effects of In-between Meal Products on Cognitive Function in the Elderly
Sponsor:
Örebro University Sweden
Organization:
Örebro University Sweden
Study Overview
Official Title:
Effects of a Nutritionally Balanced In-between Meal Food Product on Cognitive Function in the Elderly - an Explorative Study
Status:
RECRUITING
Status Verified Date:
2024-08
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:
Minimeal
Brief Summary:
The overall aim of the present 9-week intervention study is to determine how a healthy drinkable in between meal affects cognitive function and brain activity in healthy adults 70 years and older Secondary the study also investigates the impact of the intervention on low grade inflammation immune function gut health body composition physical function and well-being as secondary or exploratory outcomes The study products have the potential to lower chronic low-grade inflammation in the elderly improve nutrition and thereby contribute to healthy aging including cognitive function and the study will also give additional insight regarding secondary and exploratory outcomes
Detailed Description:
The current study is a nine week three-arm randomized controlled trial that includes a double-blinded two-armed intervention and a non-blinded comparative arm without any intervention This study will investigate the effects of a healthy in between meal consisting of processed oats and chickpeas on cognitive function and functional brain activity in healthy older men and women 70 years and older primary endpoints and explore the effect of the intervention product on blood markers body composition physical activity physical function and self-reported well-being in the earlier mentioned population secondary endpoint Furthermore the study will give insight in the preventative value of the intervention product on earlier mentioned age-related conditions as well as adherence to the study product and gives guidance towards further research regarding the effect of food product on age related conditions Participants will visit the study centre at seven occasions one time before pre visit and six times during the study period to perform one or more tests andor examinations The pre visit takes place before the baseline visit 1 and 2 are at baseline and visit 3 and 4 are the mid-study-visits in week 3 and 6 of the interventional period Visit 5 and 6 take place at the last interventional week ie week 9 Data and sample collection takes place as following
visit 0 Eligibility screening and informed consent
Week 1 visit 1 baseline Body composition blood samples fecal samples questionnaires and physical activity and function cognitive function
Week 1 visit 2 baseline fMRI Structural MRI RS-MRI N-back task fMRI word recognition task
Week 3 visit 3 intermediate visit I Body composition blood samples questionnaires compliance
Week 6 visit 4 Intermediate visit I Body composition blood samples questionnaires compliance
Week 9 visit 5 study end same procedure as visit 1
Week 9 Visit 6 study end same procedure as visit 2
visit 0 Eligibility screening and informed consent
Week 1 visit 1 baseline Body composition blood samples fecal samples questionnaires and physical activity and function cognitive function
Week 1 visit 2 baseline fMRI Structural MRI RS-MRI N-back task fMRI word recognition task
Week 3 visit 3 intermediate visit I Body composition blood samples questionnaires compliance
Week 6 visit 4 Intermediate visit I Body composition blood samples questionnaires compliance
Week 9 visit 5 study end same procedure as visit 1
Week 9 Visit 6 study end same procedure as visit 2
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