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

250 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Berry fruit powder OR nutritional ketosis for memory problems in overweight adults?

Research suggests that a low carbohydrate diet, which induces nutritional ketosis, can improve memory performance in older adults with mild cognitive impairment. Additionally, higher levels of ketones may protect against cognitive impairment related to diet, and reducing carbohydrate intake might offer cognitive benefits. ^{1 2 3 4 5}

Is the nutritional intervention for memory problems in overweight adults safe?

Research suggests that diets inducing ketosis, like the modified Atkins diet, are generally safe and may even improve memory and energy levels in people with mild cognitive impairment. However, adherence to such diets can be challenging, and individual responses may vary. ^{2 3 5 6 7}

How does the treatment for memory problems in overweight adults differ from other treatments?

This treatment is unique because it uses berry fruit powder or a low-carbohydrate diet to potentially improve memory in overweight adults, which is different from standard treatments that may not focus on dietary changes. The use of nutritional ketosis (a state where the body burns fat for fuel instead of carbohydrates) is particularly novel, as it may protect against cognitive impairment linked to high-carbohydrate diets. ^{2 3 5 8 9}

What is the purpose of this trial?

Nutritional intervention in overweight middle aged individuals with subjective memory complaints.

Research Team

Robert Krikorian, PhD

Principal Investigator

University of Cincinnati Academic Health Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Increased Carbohydrate Intake is Associated with Poorer Performance in Verbal Memory and Attention in an APOE Genotype-Dependent Manner. [2018]

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

Dietary ketosis enhances memory in mild cognitive impairment. [2022]

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

Inter-relationships among diet, obesity and hippocampal-dependent cognitive function. [2021]

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

Impact of a Multidomain Intensive Lifestyle Intervention on Complaints About Memory, Problem-Solving, and Decision-Making Abilities: The Action for Health in Diabetes Randomized Controlled Clinical Trial. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Serum Lutein is related to Relational Memory Performance. [2020]

6. Netherlands 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. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Rapid and reversible impairment of episodic memory by a high-fat diet in mice. [2022]

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

Improving Adherence to a Mediterranean Ketogenic Nutrition Program for High-Risk Older Adults: A Pilot Randomized Trial. [2023]

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

A randomized controlled trial examining the effects of behavioral weight loss treatment on hippocampal volume and neurocognition. [2023]