Essential Fats for Cognitive Decline

(EFFECT Trial)

Overseen By Martha Belury, PhD, RDN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

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

Disqualifiers: Diabetes, Cancer, GI diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 1 week

88 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether eating walnuts or a Simply White Dairy-free chocolate bar can improve thinking and memory after meals in individuals who feel their cognitive abilities are declining. It explores how these snacks might affect the gut-brain connection. The trial seeks participants who often feel their memory isn't as sharp as it used to be, have a BMI of 30 or higher, and do not have diabetes. As an unphased trial, it offers a unique opportunity to contribute to understanding how dietary choices might enhance cognitive health.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that walnuts have been studied for their impact on brain health. These studies suggest that eating walnuts can improve memory and learning. They also report better movement coordination and reduced anxiety. Eating walnuts is generally considered safe.

The Simply White Dairy-free chocolate bar contains no dairy, gluten, soy, or refined sugar. Although specific safety data for this product is unavailable, ingredients like cocoa in chocolate are usually safe when consumed in moderation.

Both treatments in the study appear well-tolerated based on current information. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they're exploring the potential of everyday foods like walnuts and dairy-free chocolate-style bars to support cognitive health. Unlike conventional treatments for cognitive decline, which often involve pharmaceuticals, these options focus on natural ingredients rich in essential fats. Walnuts are packed with omega-3 fatty acids, believed to support brain function, while the Simply White Dairy-free chocolate bar offers a tasty alternative that may also contribute beneficial fats. This approach is unique because it looks at how simple dietary changes might help maintain cognitive function without the side effects associated with medication.

What evidence suggests that this trial's treatments could be effective for cognitive decline?

This trial will compare the effects of walnuts and a Simply White Dairy-free chocolate bar on cognitive decline. Research has shown that walnuts can benefit brain health. One study found that walnuts improved memory, learning, and movement skills in older adults. Another report noted that eating more nuts, especially walnuts, can boost brain function. However, some studies found that walnuts did not significantly slow memory loss over a longer time.

Regarding the Simply White Dairy-free chocolate bar, chocolate and cocoa might also benefit the brain. Research suggests that cocoa flavanols (natural compounds in chocolate) can improve memory and thinking speed. Studies have found that eating cocoa regularly can lead to better overall brain function and attention. Thus, both walnuts and chocolate with cocoa may offer some benefits for brain health. Participants in this trial will consume either walnuts or the white chocolate-style bar daily to evaluate their effects on cognitive health. ^{6 7 8 9 10}

Who Is on the Research Team?

Martha Belury, PhD, RDN

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Simply White Dairy-free chocolate bar
• Walnuts

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.

How Is the Trial Designed?

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

Simply White Dairy-free chocolate bar is already approved in United States for the following indications:

Approved in United States as Evolved Simply White Bar for:

• General health supplement
• Cognitive support

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. withpower.com withpower.com/trial/phase-cognitive-decline-2024-3a3aa

Essential Fats for Cognitive Decline (EFFECT Trial) 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9311747/

Chocolate and Cocoa-Derived Biomolecules for Brain ... These data raise the possibility that the regular consumption of cocoa flavanols may have positive implications for cognitive dysfunction.

3. researchgate.net researchgate.net/publication/370941190_Effects_of_chocolate_on_cognitive_function_in_healthy_adults_A_systematic_review_and_meta-analysis_on_clinical_trials

Effects of chocolate on cognitive function in healthy adults It is concluded that daily consumption of cocoa may provide short and middle-term effects on young adults and make them better cognitive performance.

4. theconsciousbar.co theconsciousbar.co/blogs/news/harvard-found-something-in-chocolate-that-could-change-brain-health-forever?srsltid=AfmBOor_KCe5QRo0H5iZMlV05ZHGLYRJt0xGa5CV1DiTL_tTRcn2u1bj

Harvard Found Something in Chocolate That Could ... Harvard research shows cocoa flavanols can improve memory, thinking speed, insulin resistance, and blood pressure all without drugs. The key is ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5432604/

Enhancing Human Cognition with Cocoa Flavonoids - PMC Research investigating the relations between cocoa and cognition shows dose-dependent improvements in general cognition, attention, processing speed, and ...

6. wholefoodsmarket.com wholefoodsmarket.com/product/eating-evolved-simply-white-dairy-free-chocolate-bar-25-oz-b08qtp6tmc

Simply White Dairy Free Chocolate Bar, 2.5 oz Find Eating Evolved Simply White Dairy Free Chocolate Bar, 2.5 oz at Whole Foods Market. Get nutrition, ingredient, allergen, pricing and weekly sale ...

7. nutritionix.com nutritionix.com/i/evolved/dairy-free-keto-white-chocolate-bar/621a32120a7f090008bc1364

Dairy Free Keto White Chocolate Bar Calories and other nutrition information for Dairy Free Keto White Chocolate Bar from Evolved.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4696435/

Cocoa and Chocolate in Human Health and Disease - PMC Research to date suggests that the benefits of moderate cocoa or dark chocolate consumption likely outweigh the risks.

9. amazon.com amazon.com/stores/EvolvedChocolate/page/877ED55B-2B45-4BC1-8661-E9EE30D542F9

Evolved Chocolate: Chocolate Bars Our chocolate bars are made from high-quality organic ingredients without any of the dairy, gluten, soy or refined sugar that drags you down.

10. shop.maceys.com shop.maceys.com/store/maceys/products/25939589-evolved-chocolate-white-chocolate-keto-bar-2-5-oz

Evolved Chocolate Keto White Bar • Dairy free. • Low carb. • Wheat free. • Keto diet. • Dairy-Free. • No sugar ... SAFETY FOR YOU AND THE ENVIRONMENT - All of our products are USDA Organic ...