Nutritional Intervention for Memory Problems in Overweight Adults

Overseen By Marcelle D Shidler, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Cincinnati

Disqualifiers: Diabetes, Liver disease, Kidney disease, others

Compensation: Varies

Number of Visits: Unknown

Duration: 8-12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how dietary changes might help with memory problems in overweight adults. Participants will either consume a berry fruit powder and follow a low-carbohydrate diet (nutritional ketosis) or take a placebo powder with a higher carbohydrate diet. The goal is to determine if these changes can improve memory issues. It suits those who are overweight and have noticed memory problems but do not have diabetes or other major health issues. As an unphased trial, it provides a unique opportunity to explore innovative dietary approaches to enhance memory health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

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

Research has shown that berry-based supplements and foods can improve brain function, including memory. Participants who took these supplements often experienced enhanced memory and brain activity, with no major safety concerns reported.

Similarly, the ketogenic diet, low in carbs and high in fats, has been linked to improved memory in individuals with mild memory issues. This suggests it might be safe, though some studies recommend cautious use. No major harmful side effects have been reported.

Overall, both berry fruit powder and the ketogenic diet appear well-tolerated according to research. No significant negative effects have been consistently reported. However, with any dietary change, individuals should monitor their body's reactions. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for memory problems in overweight adults because they explore natural and dietary approaches that differ from traditional medications. One treatment uses whole fruit berry powder, which is rich in antioxidants that might protect brain cells and improve memory. The other treatment involves nutritional ketosis, a low carbohydrate diet that could enhance brain function by using ketones as an alternative energy source. Unlike standard treatments that often focus on pharmaceuticals, these interventions offer a more holistic approach, potentially with fewer side effects.

What evidence suggests that this trial's treatments could be effective for memory problems?

Research has shown that eating very few carbohydrates can improve memory in older adults, especially those at risk of memory problems. One study found that reducing carbs, even for a short period, boosted memory. Additionally, foods and supplements made from berries have enhanced brain function and memory. Several studies have found that adding berries to the diet can improve thinking skills. This trial will compare different interventions: one group will receive a combination of berry fruit powder and a low-carb diet, while another group will receive a placebo powder and a higher carbohydrate diet. These findings suggest that combining berry fruit powder with a low-carb diet might help with memory issues in overweight adults. ^{1 3 6 7 8}

Who Is on the Research Team?

Robert Krikorian, PhD

Principal Investigator

University of Cincinnati Academic Health Center

Are You a Good Fit for This Trial?

This trial is for overweight middle-aged individuals who feel like their memory isn't as good as it used to be. It's not suitable for those with diabetes, age-related memory issues, liver or kidney diseases, neurological or psychiatric conditions, or substance abuse problems.

Inclusion Criteria

I am overweight and feel that my memory is not as good as it used to be.

Exclusion Criteria

I have been diagnosed with a memory disorder related to aging.

I have a history of diabetes.

I have had liver or kidney disease in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either whole fruit berry powder with a low carbohydrate diet or placebo powder with a higher carbohydrate diet

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Berry fruit powder OR nutritional ketosis
• Placebo powder OR higher carbohydrate

Trial Overview

The study is testing the effects of a berry fruit powder that has more carbohydrates versus a nutritional ketosis approach on cognitive function in people concerned about their weight and memory. Some participants will receive a placebo powder instead.

How Is the Trial Designed?

Group I: Active supplement, low carbohydrate Active Control 1 Intervention

Whole fruit berry powder, low carbohydrate diet

Group II: Placebo, Control Placebo Group 1 Intervention

placebo powder, higher carbohydrate diet

Who Is Running the Clinical Trial?

University of Cincinnati

Lead Sponsor

Trials

442

Recruited

639,000+

Published Research Related to This Trial

The Mediterranean ketogenic nutrition (MKN) program that included motivational interviewing and behavior change techniques led to higher participant retention (82%) and attendance (91%) compared to a standard education program, indicating it may be more effective in engaging older adults with memory concerns.

Participants in the MKN Adherence program showed better adherence to the diet and some clinical benefits, although these benefits were less pronounced at the 3-month follow-up, suggesting that ongoing support may be necessary for sustained effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Adherence to a Mediterranean Ketogenic Nutrition Program for High-Risk Older Adults: A Pilot Randomized Trial. Sheffler, JL., Kiosses, DN., He, Z., et al.[2023]

A phase I/II clinical trial involving 27 patients with mild cognitive impairment or early Alzheimer's disease tested a modified Atkins diet (MAD) to induce ketone production, which may provide an alternative energy source for the brain.

Preliminary results showed that participants in the MAD group who produced trace amounts of ketones experienced a significant improvement in memory scores and reported increased energy, suggesting that even small amounts of ketones could benefit cognitive function in early Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Report on the Feasibility and Efficacy of the Modified Atkins Diet for Treatment of Mild Cognitive Impairment and Early Alzheimer's Disease. Brandt, J., Buchholz, A., Henry-Barron, B., et al.[2020]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3116949/

Dietary ketosis enhances memory in mild cognitive impairment

These findings indicate that very low carbohydrate consumption, even in the short-term, can improve memory function in older adults with increased risk for ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8881511/

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Existing evidence concludes that berry-based supplements and foods have beneficial effects on resting brain perfusion, cognitive function, memory performance.

3.

frontiersin.org

frontiersin.org/journals/nutrition/articles/10.3389/fnut.2023.1257472/full

A mixture of Nordic berries improves cognitive function ...

The results show that supplementation with the berry mixture may have beneficial effects on spatial memory, as seen by enhanced performance in the T–maze and ...

4.

mdpi.com

mdpi.com/2072-6643/14/14/2977

Systematic Review on the Potential Effect of Berry Intake in ...

The aim of this systematic review is to explore the impact of berries supplementation on cognitive function in healthy adults and the elderly.

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researchgate.net

researchgate.net/publication/224847064_Dietary_Intakes_of_Berries_and_Flavonoids_in_Relation_to_Cognitive_Decline

Dietary Intakes of Berries and Flavonoids in Relation to ...

... Some human intervention studies have also reported that cognitive function can be improved after berry supplementation [69,[73][74][75].

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S1279770723008539

The Ketogenic Diet and Alzheimer's Disease

Research suggests that diet may play a role in AD, but it is inconclusive relative to which dietary approach provides the most neuroprotective effects.

7.

mdpi.com

mdpi.com/2072-6643/12/4/1019

Influence of the Mediterranean and Ketogenic Diets on ...

Both Mediterranean and Ketogenic diets may reduce or delay cognitive impairment, with MedDi being more effective, but KD should be limited.

8.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/full/10.1002/fsn3.70516

Role of Dietary Carbohydrates in Cognitive Function: A ...

Dietary carbohydrates play an important role in mood regulation, mental health, and cognitive performance, which is driving rapid development in studies on the ...