Effect of Walnuts on Cognitive Function and Gut Microbiome in Older Adults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55+
SponsorOregon State University
About this trial
The purpose of this study is to examine the impact of daily consumption of walnuts for 12 weeks on cognitive function, markers of inflammation and oxidative stress, and the gut microbiome in healthy adults age 55 years and older.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 55 years or older
Able to hear well enough to understand spoken instructions and questions
Able to see well enough to read and respond to printed instructions and fill out questionnaires (corrective lenses are allowed)
Able to write legibly and move a computer joystick with at least one hand (i.e., no injury or connective tissue or joint disorder that would impair ability to write or make hand movements)
Disqualifiers
Consumption of walnuts, pecans, and chestnuts combined greater than 2 oz / week in the past 3 months.
Use of oral antibiotics in the past month
Regular use of oral anti-inflammatory medications in the past month
Nut, wheat, or gluten allergy/intolerance
Trial design
Design model
Parallel
Treatments tested in this trial
Walnuts
Other interventionDaily consumption of 1.5 ounces of plain walnuts for 12 weeks
Crackers
Other interventionDaily consumption of non-whole grain crackers for 12 weeks (caloric equivalent to 1.5 ounces of plain walnuts)
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: WalnutsActive comparator 1 intervention
Group B: CrackersPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Cognitive function - memory
Change from baseline at week 12: age adjusted standard scores (higher score reflects positive outcome)
Time frame
0 and 12 weeks2
Cognitive function - memory
Change from baseline at week 12: proximity (lower score reflects positive outcome)
Time frame
0 and 12 weeks3
Cognitive function - cognitive flexibility
Change from baseline at week 12: age adjusted standard scores (higher score reflects positive outcome)
Time frame
0 and 12 weeks4
Cognitive function - cognitive flexibility
Change from baseline at week 12: proximity (lower score reflects positive outcome)
Time frame
0 and 12 weeksSecondary outcomes
1
Urolithin concentrations
Change from baseline at week 12: urolithin A and urolithin B concentrations in urine
Time frame
0 and 12 weeks2
Blood pressure
Change from baseline at week 12: systolic and diastolic blood pressure
Time frame
0 and 12 weeks3
Weight
Change from baseline at week 12: weight
Time frame
0 and 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Oregon State University
Lead sponsor
California Walnut Commission
Collaborator
Source ClinicalTrials.gov