Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06433037
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-05-17
Brief Title:
Gut-brain Health Effects of PREbiotics in Older Adults With Suspected COgnitive DEcline
Sponsor:
Wageningen University
Organization:
Wageningen University
Study Overview
Official Title:
Gut-brain Health Effects of PREbiotics in Older Adults With Suspected COgnitive DEcline The PRECODE Study
Status:
RECRUITING
Status Verified Date:
2024-07
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:
PRECODE
Brief Summary:
As people around the world are living longer the number of individuals with dementia particularly Alzheimers disease AD is expected to triple by 2050 Theres growing evidence suggesting that our gut health might play a role in the prevention of dementia The connection between our gut and brain known as the gut-brain axis is becoming an important area of study Research in animals has shown that different types of dietary fibre can improve gut health brain function mood blood sugar level and the immune system and may even prevent certain harmful brain changes seen in Alzheimers disease Subjective Cognitive Decline SCD is a condition where individuals notice a decline in their mental abilities and it can be an early sign of Alzheimers disease
The goal of this clinical trial is to learn if dietary fibres can improve gut and brain health in older individuals between the ages of 60 and 79 years who notice problems in their mental abilities and meet the criteria of SCD Three different dietary fibres will be given and researchers will compare three different fibres to a placebo product to see if there is a difference between the fibres and the placebo
The main questions it aims to answer are
1 Does dietary fibre improve working memory
2 Does dietary fibre improve other markers of brain function
3 Does dietary fibre improve gut health
4 Does dietary fibre improve the immune system and blood glucose levels
5 Does dietary fibre improve mood
Participants will
Consume dietary fibres twice a day mixed in water tea or coffee for a period of 26 weeks
Have two functional MRI scans and three additional study visits where blood urine and feces will be collected
Undergo a number of neuropsychological tests aimed at evaluating brain function
Fill out questionnaires on their general health mood dietary habits gut health
Wear smartwatches for one week at the beginning and the end of the study
The goal of this clinical trial is to learn if dietary fibres can improve gut and brain health in older individuals between the ages of 60 and 79 years who notice problems in their mental abilities and meet the criteria of SCD Three different dietary fibres will be given and researchers will compare three different fibres to a placebo product to see if there is a difference between the fibres and the placebo
The main questions it aims to answer are
1 Does dietary fibre improve working memory
2 Does dietary fibre improve other markers of brain function
3 Does dietary fibre improve gut health
4 Does dietary fibre improve the immune system and blood glucose levels
5 Does dietary fibre improve mood
Participants will
Consume dietary fibres twice a day mixed in water tea or coffee for a period of 26 weeks
Have two functional MRI scans and three additional study visits where blood urine and feces will be collected
Undergo a number of neuropsychological tests aimed at evaluating brain function
Fill out questionnaires on their general health mood dietary habits gut health
Wear smartwatches for one week at the beginning and the end of the study
Detailed Description:
Rationale Due to the greying of society a triplication of the number of people with dementia worldwide with Alzheimers disease AD as the commonest form is expected by 2050 Compelling evidence points towards a crucial role of intestinal health as one potential etiological modifier of dementia with the microbiota gut-brain axis MGBA receiving increasing attention A number of preclinical studies have demonstrated benefit of various sources of dietary fibre for their capacity to improve gut health cognitive functioning general mood glycaemia immunogenicity and to inhibit tau phosphorylation the latter which is a hallmark in AD brain Subjective cognitive decline SCD lies on the continuum of AD and subjects with this condition are at increased risk of further conversion to mild cognitive impairment MCI or AD Currently no cure is available for AD Various symptomatic and a few disease-modifying treatments are available but these treatments only have very limited or mild clinical effects and are often accompanied by severe side effects Clinical follow-up studies to evaluate the effect of dietary fibre in older adults with suspected cognitive decline are required but are still lacking to date
Objective The primary objective of this study is to investigate the effect of 26 weeks of supplementation with three different dietary fibres chicory inulin resistant dextrin and seaweed polysaccharide compared to a placebo maltodextrin on microbiota gut-brain health effects in older adults aged 60-79 with Subjective Cognitive Decline Plus SCD by assessing changes in brain function and working memory by blood oxygen level dependant BOLD signal activity and task accuracy during n-back task functional magnetic resonance imaging fMRI assessment
The secondary objectives are to investigate the effects of 26 weeks of supplementation with dietary fibre chicory inulin resistant dextrin and seaweed polysaccharide compared to placebo maltodextrin in older adults on the following parameters related to potential gut-brain pathways
1 neuropsychological test battery scoring
2 other relevant brain health parameters
3 relevant intestinal health parameters and
4 immune and metabolic parameters
Study population 164 older adults 60-79 years with SCD
Study design implementation
Participants will undergo assessments at baseline T0 mid-study T12 after 13 weeks and at study end T1 after 26 weeks Each participant will have five study visits in total two at T0 one at T12 and two at T1
At each of the timepoints the following will be collectedperformed at WUR Sample collection blood urine omitted in week 13 faeces general cognitive assessments see NTB Cognitive Failure Questionnaire CFQ baseline and end only GDS-15 GAD-7 general physiological measures blood pressure BMI grip-strength dietary assessment MIND-adjusted Eetscore FFQ At ZGV working memory will be evaluated using BOLD fMRI signalling and task accuracy using an n-back task paradigm Additionally high-resolution T1- and T2-weighted anatomical images of main regions of interest hippocampi prefrontal- and temporal cortices will be acquired
For two periods of one week corresponding with the baseline and week 26 visits participants will wear smartwatches These watches will be worn continuously and data will be gathered regarding cardiovascular functioning heart rate physical activity and mood push messages
Objective The primary objective of this study is to investigate the effect of 26 weeks of supplementation with three different dietary fibres chicory inulin resistant dextrin and seaweed polysaccharide compared to a placebo maltodextrin on microbiota gut-brain health effects in older adults aged 60-79 with Subjective Cognitive Decline Plus SCD by assessing changes in brain function and working memory by blood oxygen level dependant BOLD signal activity and task accuracy during n-back task functional magnetic resonance imaging fMRI assessment
The secondary objectives are to investigate the effects of 26 weeks of supplementation with dietary fibre chicory inulin resistant dextrin and seaweed polysaccharide compared to placebo maltodextrin in older adults on the following parameters related to potential gut-brain pathways
1 neuropsychological test battery scoring
2 other relevant brain health parameters
3 relevant intestinal health parameters and
4 immune and metabolic parameters
Study population 164 older adults 60-79 years with SCD
Study design implementation
Participants will undergo assessments at baseline T0 mid-study T12 after 13 weeks and at study end T1 after 26 weeks Each participant will have five study visits in total two at T0 one at T12 and two at T1
At each of the timepoints the following will be collectedperformed at WUR Sample collection blood urine omitted in week 13 faeces general cognitive assessments see NTB Cognitive Failure Questionnaire CFQ baseline and end only GDS-15 GAD-7 general physiological measures blood pressure BMI grip-strength dietary assessment MIND-adjusted Eetscore FFQ At ZGV working memory will be evaluated using BOLD fMRI signalling and task accuracy using an n-back task paradigm Additionally high-resolution T1- and T2-weighted anatomical images of main regions of interest hippocampi prefrontal- and temporal cortices will be acquired
For two periods of one week corresponding with the baseline and week 26 visits participants will wear smartwatches These watches will be worn continuously and data will be gathered regarding cardiovascular functioning heart rate physical activity and mood push messages
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