Essential Fats for Cognitive Decline

(EFFECT Trial)

Overseen By Rachel Cole

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Ohio State University

Must not be taking: Diabetes meds, Psychostimulants, Nootropics, Weight loss meds

Disqualifiers: Diabetes, Cancer, GI diseases, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using diabetes medications, psychostimulants, nootropic medications, or weight loss supplements. If you are taking any of these, you would need to stop before joining the trial.

What data supports the effectiveness of the treatment Simply White Dairy-free chocolate bar, Evolved Simply White Bar, Dairy-free White Chocolate Bar, Walnuts, English walnut, Persian walnut, Juglans regia for cognitive decline?

Research suggests that walnuts, which are part of the treatment, may improve cognitive function. Studies have shown that walnut consumption is associated with better cognitive performance in both humans and animals, likely due to their high content of omega-3 fatty acids and antioxidants. ^{1 2 3 4 5}

Is the treatment generally safe for humans?

Walnuts are generally safe for most people, but they can cause severe allergic reactions in some individuals. Additionally, the levels of potentially harmful elements like arsenic and lead in walnuts are below the maximum allowed values, indicating they are safe to consume in typical amounts. ^{4 6 7 8 9}

How does the treatment with Simply White Dairy-free chocolate bar and Walnuts differ from other treatments for cognitive decline?

This treatment is unique because it combines dairy-free chocolate and walnuts, which are rich in essential fats that may support brain health, unlike traditional treatments that often focus on pharmaceuticals. The inclusion of walnuts, known for their high content of omega-3 fatty acids, offers a dietary approach to potentially slow cognitive decline. ^{10 11 12 13 14}

Research Team

Martha Belury, PhD, RDN

Principal Investigator

Ohio State University

Eligibility Criteria

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.

Inclusion Criteria

Subjective cognitive impairment

BMI ≥30 kg/m2

HbA1C <6.5%

Exclusion Criteria

Use of some oil supplements in the past 4 weeks prior to enrolling

I cannot have blood drawn because my veins are hard to access.

Alcohol or drug abuse

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants consume 1 study snack per day for 1 week to assess changes in cognitive function and the gut-brain axis

1 week

Daily consumption

Crossover

Participants switch to the alternate study snack for another week to compare effects

1 week

Daily consumption

Follow-up

Participants are monitored for changes in cognitive function and biomarkers after treatment

4 weeks

Visits at Week 5 and Week 6

Treatment Details

Interventions

• Simply White Dairy-free chocolate bar (Other)
• Walnuts (Other)

Trial Overview 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.

Participant Groups

Group I: White chocolate-style bar Experimental Treatment 1 Intervention

consumption of a white chocolate-style bar every day

Group II: Walnuts Experimental Treatment 1 Intervention

consumption of walnuts every day

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

United States Department of Agriculture (USDA)

Collaborator

Trials

103

Recruited

287,000+

The California Walnut Commission

Collaborator

Trials

1

Recruited

90+

Findings from Research

Aged rats fed a moderate walnut diet (2% and 6%) for 8 weeks showed improved motor skills, particularly in tasks like rod walking and medium plank walking, indicating that walnuts can enhance motor performance.

All walnut diets improved working memory in cognitive tests, but the highest dose (9%) led to impaired reference memory, suggesting that while walnuts can be beneficial, too much may have negative effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose-dependent effects of walnuts on motor and cognitive function in aged rats. Willis, LM., Shukitt-Hale, B., Cheng, V., et al.[2009]

Feeding pregnant and lactating rats a diet including walnut kernel (6% of food intake) significantly improved the learning and memory abilities of their offspring, as demonstrated by the Morris water maze test.

The study suggests that the beneficial constituents in walnuts, such as unsaturated fatty acids and vitamin E, may play a role in enhancing cognitive functions in the next generation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maternal feeding with walnuts (Juglans regia) improves learning and memory in their adult pups. Asadi-Shekaari, M., Karimi, A., Shabani, M., et al.[2021]

In a 2-year study involving 708 cognitively healthy elders, walnut supplementation did not show a significant overall effect on global cognition compared to a control diet, with both groups experiencing similar declines in cognitive scores.

However, post hoc analyses indicated that participants from Barcelona who consumed walnuts experienced a smaller decline in cognitive scores compared to controls, suggesting that walnuts may have potential benefits for subgroups at higher risk of cognitive decline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a 2-year diet intervention with walnuts on cognitive decline. The Walnuts And Healthy Aging (WAHA) study: a randomized controlled trial. Sala-Vila, A., Valls-Pedret, C., Rajaram, S., et al.[2023]

Processed cheeses fortified with walnut paste (5-10%) significantly increased healthy fatty acids, including omega-3s, while reducing unhealthy saturated fats, making them a better nutritional choice.

Cheeses with walnut paste maintained good sensory qualities and technological properties, suggesting that this fortification can enhance both health benefits and taste.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physicochemical, Functional, Fatty Acids Profile, Health Lipid Indices, Microstructure and Sensory Characteristics of Walnut-Processed Cheeses. Abbas, KA., Abdelmontaleb, HS., Hamdy, SM., et al.[2021]

A study of US adults aged 20 to 90 found that those consuming walnuts showed significant improvements in cognitive function, with younger adults (20-59 years) responding faster on cognitive tests and older adults (60+) scoring higher on memory and processing speed tests.

Higher walnut consumption was associated with better cognitive outcomes across all age groups, suggesting that incorporating walnuts into the diet may enhance cognitive performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A cross sectional study of the association between walnut consumption and cognitive function among adult US populations represented in NHANES. Arab, L., Ang, A.[2018]

In a study involving 40 healthy participants aged 50 and older, consuming 43g of walnuts daily for 8 weeks significantly reduced non-HDL cholesterol and apolipoprotein-B levels, which are important markers related to heart disease risk.

Despite these positive changes in cholesterol levels, other factors such as fasting glucose, insulin, and markers of inflammation and endothelial function did not show significant changes, indicating that walnuts may specifically target lipid profiles without affecting other metabolic parameters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Walnut-enriched diet reduces fasting non-HDL-cholesterol and apolipoprotein B in healthy Caucasian subjects: a randomized controlled cross-over clinical trial. Wu, L., Piotrowski, K., Rau, T., et al.[2022]

In a study of 91 walnut-allergic patients and 24 tolerant controls, sensitization to walnut proteins was found to be more common in children under 14, with severe allergic reactions reported in all of these younger patients.

Higher levels of specific IgE (sIgE) to walnut proteins, particularly rJug r 1 and nJug r 4, were associated with more severe allergic reactions, indicating that these proteins are key indicators of the severity of walnut allergies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Allergen Recognition Patterns in Walnut Allergy Are Age Dependent and Correlate with the Severity of Allergic Reactions. Ballmer-Weber, BK., Lidholm, J., Lange, L., et al.[2020]

Walnuts are rich in essential macro-elements like calcium, potassium, magnesium, and sodium, which are beneficial for health, with potassium being the most abundant at 2771 mg/kg.

The study found that potentially toxic trace elements like arsenic, cadmium, and lead were present in walnuts but below the maximum allowed values, indicating that walnuts can be considered safe for consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mineral Composition of Elements in Walnuts and Walnut Oils. Juranović Cindrić, I., Zeiner, M., Hlebec, D.[2020]

A new enzyme-linked immunosorbent assay (ELISA) was developed to detect walnut protein residues in food, achieving a detection limit of 1 ppm, which is crucial for ensuring food safety for individuals with walnut allergies.

The ELISA demonstrated effective recovery rates of walnut protein in various food products, such as chocolate and cookies, and showed significant cross-reactivity with pecans, highlighting the need for careful allergen labeling in food manufacturing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of walnut residues in foods using an enzyme-linked immunosorbent assay. Niemann, L., Taylor, SL., Hefle, SL.[2009]

Supplementation with milk fat globule membrane (MFGM) concentrate in aged rats improved spatial working memory, suggesting potential cognitive benefits from this dietary intervention.

MFGM supplementation altered the lipid composition of synaptic membranes, increasing levels of beneficial fatty acids and phospholipids, which may help restore brain function and prevent age-related cognitive decline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Milk fat globule membrane concentrate as a nutritional supplement prevents age-related cognitive decline in old rats: A lipidomic study of synaptosomes. Baliyan, S., Calvo, MV., Piquera, D., et al.[2023]

In a study of 6744 Spanish adults aged 55-75, higher consumption of milk and dairy products was associated with a greater prevalence of cognitive decline, as measured by the Mini-Mental State Examination (MMSE).

Conversely, lower consumption of milk (<220 g/day) was linked to better cognitive performance, while whole-fat milk consumption showed a positive correlation with higher MMSE scores, suggesting it may be associated with less cognitive impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Milk and Dairy Products Intake Is Related to Cognitive Impairment at Baseline in Predimed Plus Trial. Muñoz-Garach, A., Cornejo-Pareja, I., Martínez-González, MÁ., et al.[2021]

Regular consumption of low-fat dairy products may support neurocognitive health in aging individuals, potentially helping to prevent age-related cognitive decline and dementia.

The review highlights beneficial components in dairy, such as bioactive peptides, calcium, and vitamin B12, which may positively influence brain function and metabolic health, although further research is needed to fully understand these effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dairy constituents and neurocognitive health in ageing. Camfield, DA., Owen, L., Scholey, AB., et al.[2017]

In a study of 482 women aged 60 and older over a 3-year period, higher intake of monounsaturated fats (MUFA) was linked to less cognitive decline, particularly in memory and visual functions.

Conversely, there was no significant association between cognitive decline and the intake of saturated fats, trans fats, or dietary cholesterol, suggesting that not all dietary fats impact cognitive health equally.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monounsaturated, trans, and saturated Fatty acids and cognitive decline in women. Naqvi, AZ., Harty, B., Mukamal, KJ., et al.[2021]

In a study of 1,183 adults aged 39 to 65, low fat dairy consumption, particularly low fat yogurt and cheese, was linked to improved memory recall and social functioning, suggesting potential cognitive benefits.

Conversely, whole fat dairy products were associated with increased levels of depression, anxiety, and cognitive failures, indicating that the type of dairy consumed may significantly impact psychological well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dairy intake and cognitive health in middle-aged South Australians. Crichton, GE., Murphy, KJ., Bryan, J.[2015]

References

1. England pubmed.ncbi.nlm.nih.gov

Dose-dependent effects of walnuts on motor and cognitive function in aged rats. [2009]

2. Iran pubmed.ncbi.nlm.nih.gov

Maternal feeding with walnuts (Juglans regia) improves learning and memory in their adult pups. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Effect of a 2-year diet intervention with walnuts on cognitive decline. The Walnuts And Healthy Aging (WAHA) study: a randomized controlled trial. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Physicochemical, Functional, Fatty Acids Profile, Health Lipid Indices, Microstructure and Sensory Characteristics of Walnut-Processed Cheeses. [2021]

5. France pubmed.ncbi.nlm.nih.gov

A cross sectional study of the association between walnut consumption and cognitive function among adult US populations represented in NHANES. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Walnut-enriched diet reduces fasting non-HDL-cholesterol and apolipoprotein B in healthy Caucasian subjects: a randomized controlled cross-over clinical trial. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Allergen Recognition Patterns in Walnut Allergy Are Age Dependent and Correlate with the Severity of Allergic Reactions. [2020]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Mineral Composition of Elements in Walnuts and Walnut Oils. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Detection of walnut residues in foods using an enzyme-linked immunosorbent assay. [2009]

10. Canada pubmed.ncbi.nlm.nih.gov

Milk fat globule membrane concentrate as a nutritional supplement prevents age-related cognitive decline in old rats: A lipidomic study of synaptosomes. [2023]

11. Germany pubmed.ncbi.nlm.nih.gov

Milk and Dairy Products Intake Is Related to Cognitive Impairment at Baseline in Predimed Plus Trial. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Dairy constituents and neurocognitive health in ageing. [2017]

13. United States pubmed.ncbi.nlm.nih.gov

Monounsaturated, trans, and saturated Fatty acids and cognitive decline in women. [2021]

14. China pubmed.ncbi.nlm.nih.gov

Dairy intake and cognitive health in middle-aged South Australians. [2015]