Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06605898
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
Optimized Tailored Interventions in Metabolic and Lifestyle Outcomes OPTIMAL
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Optimized Tailored Interventions in Metabolic and Lifestyle Outcomes Examining the Effects of the Mediterranean-DASH Intervention for Neurodegenerative DelayMIND on Cognitive Performance Metabolic Health and Lifestyle Outcomes Using Advanced Machine Learning Strategies
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn if increasing adherence to a Mediterranean-DASH Intervention for Neurodegenerative Delay MIND diet pattern improves brain and heart health relative to a healthy control diet in middle-aged adults Our research team will evaluate three different groups the first group will be chosen using a predictive analytics model that predicts who will benefit most from the MIND diet the second group will follow the MIND diet without being pre-selected and the third group will eat a standard healthy diet to serve as a comparison
The main questions it aims to answer are
Does the MIND diet improve cognitive performance and heart health relative to a control diet How does the health impact of the MIND diet in participants pre-identified through predictive analytics compare to those without such pre-selection Which of the three groups - predictive analytics selected MIND diet group standard MIND diet group or healthy control - demonstrate the most significant improvements in cognitive and cardiovascular health over the course of the trial
Participants will
Consume one meal that follows the MIND diet or a control meal every day for 3 months Visit the lab before and after the 3 months of meals for tests Keep a record of the food they eat during the study
The main questions it aims to answer are
Does the MIND diet improve cognitive performance and heart health relative to a control diet How does the health impact of the MIND diet in participants pre-identified through predictive analytics compare to those without such pre-selection Which of the three groups - predictive analytics selected MIND diet group standard MIND diet group or healthy control - demonstrate the most significant improvements in cognitive and cardiovascular health over the course of the trial
Participants will
Consume one meal that follows the MIND diet or a control meal every day for 3 months Visit the lab before and after the 3 months of meals for tests Keep a record of the food they eat during the study
Detailed Description:
The purpose of this study is to understand how a healthy diet is related to thinking ability and heart health Participants will be asked to consume a microwaveable study meal or prepackaged smoothie every day for 12 weeks These meals will be delivered to participant homes using Daily Harvest meal delivery service The study meals and smoothies will follow either a dietary pattern thought to improve brain and heart health MIND or a control diet and will include foods commonly found in grocery stores Participants will not know which diet they are assigned to active or control Participants will also be asked to follow simple dietary guidance on a healthy diet in addition to the meals provided Participants will complete a series of online forms or surveys Additionally participants will come to 4 in-person laboratory visits to complete several computer-based tests of memory and attention while wearing an EEG cap Participants will also be asked to complete an eye test a heart rate and blood pressure assessment a bone and body scan called DXA and a blood draw at the beginning of the study and again at the end of the 12-week diet period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None