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Behavioural Intervention

MIND Diet for Brain and Heart Health

N/A

Recruiting

Led By Naiman Khan, PhD

Research Sponsored by University of Illinois at Urbana-Champaign

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Not currently taking oral hypoglycemic agents, or insulin

45-64 years of age

Must not have

Cognitively impaired and/or prior diagnosis of neurological disease (i.e., mild cognitive impairment, Alzheimer's disease, vascular dementia, and/or Asperger's syndrome)

Above 64 or below 45 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up [time frame: 12 weeks (baseline vs follow-up)]

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if following a MIND diet, which is a mix of Mediterranean and DASH diets, can improve brain and heart health in middle-aged adults compared to a standard healthy diet.

Who is the study for?

This trial is for middle-aged adults interested in improving brain and heart health through diet. Participants should be willing to consume a specific meal daily for 3 months and visit the lab for tests. There's no mention of specific exclusions, so generally healthy individuals may apply.

What is being tested?

The OPTIMAL study is testing whether the MIND diet can boost cognitive performance and heart health compared to a standard healthy diet. It involves three groups: one selected by predictive analytics, another following the MIND diet without selection, and a control group on a regular healthy diet.

What are the potential side effects?

Since this trial focuses on dietary interventions (MIND Diet vs. Control Diet), side effects are likely minimal but could include digestive changes or food sensitivities as participants adjust to new eating patterns.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not taking any diabetes medication.

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I am between 45 and 64 years old.

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I have never had weight loss surgery.

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I do not have liver, GI diseases, hepatitis, HIV, or cancer.

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I have no history of neurological diseases like Alzheimer's or dementia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with a cognitive or neurological condition.

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I am older than 64 or younger than 45.

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I have had liver, gastrointestinal diseases, hepatitis, HIV, or another type of cancer.

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I am currently taking medication for diabetes.

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I have had weight loss surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ [time frame: 12 weeks (baseline vs follow-up)]

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~[time frame: 12 weeks (baseline vs follow-up)]

This trial's timeline: 3 weeks for screening, Varies for treatment, and [time frame: 12 weeks (baseline vs follow-up)] for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Attentional Accuracy

Attentional Processing Speed

Attentional Reaction Time

+6 more

Secondary study objectives

Macular Pigment Optical Density

Visceral Adipose Tissue

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Standard MIND dietExperimental Treatment1 Intervention

Participants in the active MIND diet group will be asked to consume one ready-to-eat meal per day from Daily Harvest® meal delivery service. This will be a standard treatment arm without prior selection through predictive analytics. The treatment meals will follow MIND diet guidelines and include leafy green vegetables, nuts, legumes, whole grains, berries, and extra virgin olive oil.

Group II: Predictive Analytics informed MIND DietExperimental Treatment1 Intervention

Participants in the active MIND diet group informed by predictive analytics will be pre-identified based on the results of a machine learning model that predicts who will most likely benefit from the MIND diet. The participants in this group will be asked to consume one ready-to-eat meal per day from Daily Harvest® meal delivery service. The treatment meals will follow MIND diet guidelines and include leafy green vegetables, nuts, legumes, whole grains, berries, and extra virgin olive oil.

Group III: Control DietActive Control1 Intervention

Participants in the control diet group will be asked to consume one ready-to-eat meal per day from Daily Harvest® meal delivery service. The Control group will receive daily meals that are isocaloric with the active/experimental meals but will follow a general diet based on the average American diet and Dietary Guidelines for Americans (i.e., vegetables, fruits, nuts, whole grains, and unsaturated fats).

0 / 10Eligibility criteria met