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Walnuts for Cognitive Decline (EFFECT Trial)
N/A
Recruiting
Led By Martha Belury, PhD, RDN
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0, week 1, week 5 and week 6
Awards & highlights
EFFECT Trial Summary
This trial aims to study how eating a specific snack daily for a week can affect brain function and the connection between the gut and the brain in adults who have memory concerns.
Who is the study for?
This trial is for adults with subjective cognitive complaints, a measure of blood sugar control (HbA1C) below 6.5%, and a body mass index (BMI) of 30 or higher, indicating obesity. It's not suitable for individuals who don't meet these specific health criteria.Check my eligibility
What is being tested?
The EFFECT study is testing whether eating walnuts or a dairy-free chocolate bar daily for one week can improve thinking skills in people who feel their mental abilities are slipping. Participants will try each snack in random order to compare effects.See study design
What are the potential side effects?
Since the interventions involve common foods (walnuts and dairy-free chocolate), side effects may include allergic reactions if sensitive to nuts or ingredients in the chocolate bar, digestive discomfort, or changes in appetite.
EFFECT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 0, week 1, week 5 and week 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0, week 1, week 5 and week 6
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cognitive function measured using the National Institutes of Health Toolbox for the Assessment of Neurological and Behavioral Function Cognitive Battery (NIHTB-CB)
Secondary outcome measures
Change in Cognitive function measured using the National Institutes of Health Toolbox for the Assessment of Neurological and Behavioral Function Cognitive Battery (NIHTB-CB)
Changes in fecal Microbiota diversity
Other outcome measures
Changes in cardiolipin species
Changes in postprandial C-Reactive Protein
Changes in postprandial IL-6
+8 moreEFFECT Trial Design
2Treatment groups
Experimental Treatment
Group I: White chocolate-style barExperimental Treatment1 Intervention
consumption of a white chocolate-style bar every day
Group II: WalnutsExperimental Treatment1 Intervention
consumption of walnuts every day
Find a Location
Who is running the clinical trial?
United States Department of Agriculture (USDA)FED
97 Previous Clinical Trials
350,674 Total Patients Enrolled
Ohio State UniversityLead Sponsor
830 Previous Clinical Trials
505,532 Total Patients Enrolled
2 Trials studying Cognitive Decline
130 Patients Enrolled for Cognitive Decline
The California Walnut CommissionUNKNOWN
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the current clinical trial open for new participant enrollment?
"Indeed, as per the information available on clinicaltrials.gov, this investigation is currently in search of volunteers. It was initially listed on February 7th, 2024 and most recently revised on February 9th, 2024. The study aims to enroll a total of 88 participants at one designated site."
Answered by AI
Can individuals above the age of 45 partake in this research endeavor?
"For this study, eligible participants must fall between the age range of 40 to 75 years. Interestingly, there are currently 31 trials catering to individuals under 18 and a substantial number of 607 trials targeting those above 65 years old."
Answered by AI
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