Cognitive DeclineEFFECTNCT06223672
Essential Fats For Enhancing Cognitive Thinking (EFFECT) Study
A study testing Walnuts and Simply White Diary-free chocolate bar in people with Cognitive Decline and Cognitive Impairment, run by Ohio State University at 1 site in United States.
Trial summary
The proposed research is a randomized crossover trial designed to assess changes in postprandial cognitive function and the gut-brain axis in adults with subjective cognitive complaints who consume 1 study snack per day for 1 week. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Cognitive Decline, Cognitive Impairment
- What is being tested?
- Walnuts and Simply White Diary-free chocolate bar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjective cognitive impairment
- BMI ≥30 kg/m2
- HbA1C <6.5%
Who cannot join
- Diagnosis og cognitive impairment or dementia
- Montreal Cognitive Assessment (MoCA) score of <26
- Current or previous diagnosis of Diabetes or use of diabetes medications
- Current diagnosis of or current treatment of cancer other than non-melanoma skin cancer
- Gastrointestinal diseases or disorders (including pancreatic and gastric bypass surgery) where consumption of the study foods would be contraindication or where the disease or disorder could negatively affect nutrient absorption and/or would prevent participants from tolerating the study foods
- Hyperthyroidism diagnosis
Show all 18Show fewer
- Food Allergy or intolerances
- Any dietary restriction where consumption of the study foods, study meals/snack or meal challenge or any ingredient would be contraindicated
- Use of some oil supplements in the past 4 weeks prior to enrolling
- Pregnancy and lactation
- Inability to access veins for venipuncture
- Antibiotic use in the past month
- Psychostimulant or nootropic medication use
- Current use of supplements or medications for weight loss or following a weight loss program
- Severe or uncontrolled autoimmune diseases
- Current or previous diagnosis of severe kidney failure, liver cirrhosis and some pulmonary diseases
- Heart disease events (including stroke or heart attack) within last 3 months prior to enrollment
- Alcohol or drug abuse
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
Martha Belury, PhD, 614-292-1680, belury.1@osu.edu
About this study
Official title: Essential Fats For Enhancing Cognitive Thinking (EFFECT) Study: Dietary Fat Quality and Cognitive Impairment
The proposed research is a randomized crossover trial designed to assess changes in postprandial cognitive function and the gut-brain axis in adults with subjective cognitive complaints who consume 1 study snack per day for 1 week.
Read the detailed description
Study objective including
- To measure the impact of dietary fats on postprandial cognitive function in adults who report subjective cognitive complaints.
- To assess the effect of dietary fat consumption on the gut-brain axis in relationship to cognitive function.
- Conditions
- Cognitive Decline, Cognitive Impairment
- Being tested
- Walnuts, Simply White Diary-free chocolate bar
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WalnutsOther
56g of walnuts consumed each day for 7 days
Simply White Diary-free chocolate barOther
68g of the white chocolate style-bar each day for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Walnuts | Experimental | consumption of walnuts every day Receives: Other: Walnuts |
| White chocolate-style bar | Experimental | consumption of a white chocolate-style bar every day Receives: Other: Simply White Diary-free chocolate bar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function measured using the National Institutes of Health Toolbox for the Assessment of Neurological and Behavioral Function Cognitive Battery (NIHTB-CB)
To determine the impact of consuming the study dietary fats as part of a high fat meal on postprandial cognitive function
Measured: Week 0 and Week 5
Secondary outcomes (2)
Change in Cognitive function measured using the National Institutes of Health Toolbox for the Assessment of Neurological and Behavioral Function Cognitive Battery (NIHTB-CB)
To assess changes in cognitive function after consuming 1 serving of the dietary fats every day for 1 week
Measured: Week 0, Week 1, Week 5 and Week 6
Changes in fecal Microbiota diversity
To assess changes in microbiota diversity of fecal samples after consuming 1 serving of the dietary fats every day for 1 week
Measured: Week 0, Week 1, Week 5 and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start7 Feb 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive DeclineStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Agriculture (USDA), The California Walnut Commission
- Responsible party
- Principal investigator, Martha Belury, Ohio State University
- Investigators
- Martha Belury, PhD, RDN, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06223672
- Sponsor's protocol ID
- 2023H0111
- Acronym
- EFFECT
- Status last verified
- Apr 2026
- First submitted
- 9 Oct 2023
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zarich S, Cole RM, Fairchild K, Spakowicz D, Sparagna G, Madison A, Ni A, Belury MA. Effects of Walnuts on Postprandial Cognitive Function in Adults With Subjective Cognitive Impairment: Protocol for a Randomized Crossover Trial. JMIR Res Protoc. 2025 Dec 19;14:e82032. doi: 10.2196/82032.
PubMed 41418290
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Essential Fats For Enhancing Cognitive Thinking (EFFECT) Study: Dietary Fat Quality and Cognitive Impairment
- ClinicalTrials.gov ID
- NCT06223672
- Acronym / sponsor ID
- EFFECT / 2023H0111
- Conditions
- Cognitive Decline, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- United States Department of Agriculture (USDA), The California Walnut Commission
- Study start
- 7 Feb 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed research is a randomized crossover trial designed to assess changes in postprandial cognitive function and the gut-brain axis in adults with subjective cognitive complaints who consume 1 study snack per day for 1 week.
Detailed description
Study objective including
- To measure the impact of dietary fats on postprandial cognitive function in adults who report subjective cognitive complaints.
- To assess the effect of dietary fat consumption on the gut-brain axis in relationship to cognitive function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Walnuts | Experimental | Other: Walnutsconsumption of walnuts every day |
| White chocolate-style bar | Experimental | Other: Simply White Diary-free chocolate barconsumption of a white chocolate-style bar every day |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjective cognitive impairment
- BMI ≥30 kg/m2
- HbA1C <6.5%
Key exclusion criteria (18 listed)
- Diagnosis og cognitive impairment or dementia
- Montreal Cognitive Assessment (MoCA) score of <26
- Current or previous diagnosis of Diabetes or use of diabetes medications
- Current diagnosis of or current treatment of cancer other than non-melanoma skin cancer
- Gastrointestinal diseases or disorders (including pancreatic and gastric bypass surgery) where consumption of the study foods would be contraindication or where the disease or disorder could negatively affect nutrient absorption and/or would prevent participants from tolerating the study foods
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walnuts56g of walnuts consumed each day for 7 days | Other | Walnuts |
| Simply White Diary-free chocolate bar68g of the white chocolate style-bar each day for 7 days | Other | White chocolate-style bar |
Primary outcome
Cognitive function measured using the National Institutes of Health Toolbox for the Assessment of Neurological and Behavioral Function Cognitive Battery (NIHTB-CB)
Time frame: Week 0 and Week 5
To determine the impact of consuming the study dietary fats as part of a high fat meal on postprandial cognitive function
2 secondary outcomes
Change in Cognitive function measured using the National Institutes of Health Toolbox for the Assessment of Neurological and Behavioral Function Cognitive Battery (NIHTB-CB)
Time frame: Week 0, Week 1, Week 5 and Week 6
Changes in fecal Microbiota diversity
Time frame: Week 0, Week 1, Week 5 and Week 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Derived from this study: PubMed 41418290Zarich S, Cole RM, Fairchild K, Spakowicz D, Sparagna G, Madison A, Ni A, Belury MA. Effects of Walnuts on Postprandial Cognitive Function in Adults With Subjective Cognitive Impairment: Protocol for a Randomized Crossover Trial. JMIR Res Protoc. 2025 Dec 19;14:e82032. doi: 10.2196/82032.
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Cognition Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Martha Belury, PhD, RDN principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walnuts and Simply White Diary-free chocolate bar in people with Cognitive Decline and Cognitive Impairment, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martha Belury, PhD, RDN (614-292-1680, belury.1@osu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive function measured using the National Institutes of Health Toolbox for the Assessment of Neurological and Behavioral Function Cognitive Battery (NIHTB-CB) (time frame: Week 0 and Week 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06223672, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.