Cognitive ChangeNCT06605898
Optimized Tailored Interventions in Metabolic and Lifestyle Outcomes (OPTIMAL)
A study testing MIND Diet in people with Cognitive Change and Diet, Healthy, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if increasing adherence to a Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet pattern improves brain and heart health relative to a healthy control diet in middle-aged adults. Read more about this study
- Who is it for?
- Ages 45 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change, Diet, Healthy, Metabolic Syndrome, Protection Against
- What is being tested?
- MIND Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jul 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 45-64 years of age
- 20/20 or corrected vision
- No food allergies or intolerances
- Not pregnant, lactating, or have given birth in the past 12 months
- Do not smoke, use tobacco, or abuse drugs
- Absence of liver or gastrointestinal diseases (i.e., primary biliary cirrhosis or gallbladder disease, chronic constipation, diarrhea, Crohn's disease, celiac disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers), hepatitis, HIV, and cancer
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- Not currently taking oral hypoglycemic agents, or insulin
- No history of malabsorptive or bariatric surgery
- Cognitively intact with no prior diagnosis of neurological disease (i.e., mild cognitive impairment, Alzheimer's disease, vascular dementia, and/or Asperger's syndrome)
- Able to consume the study meals
- Not enrolled in another dietary, exercise, or medication study during the study.
Who cannot join
- Non-consent of participant
- Above 64 or below 45 years of age
- Vision not 20/20 or corrected
- Food allergies or intolerances
- Pregnant, lactating, or have given birth in the past 12 months
- Smoke, use tobacco, or abuse drugs
Show all 12Show fewer
- Prior diagnosis of liver or gastrointestinal disease (i.e., primary biliary cirrhosis or gallbladder disease, chronic constipation, diarrhea, Crohn's disease, celiac disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers), hepatitis, HIV, or cancer
- Currently taking oral hypoglycemic agents or insulin
- History of malabsorptive or bariatric surgery
- Cognitively impaired and/or prior diagnosis of neurological disease (i.e., mild cognitive impairment, Alzheimer's disease, vascular dementia, and/or Asperger's syndrome)
- Unable to consume the study meals
- Concurrent enrollment in another dietary, exercise, or medication study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Illinois at Urbana-Champaign
Urbana, Illinois, 61801
Naiman A Khan, PhD, RD, 2173002197, nakhan2@illinois.edu
Naiman A Khan, PhD, RD
About this study
Official title: Optimized Tailored Interventions in Metabolic and Lifestyle Outcomes: Examining the Effects of the Mediterranean-DASH Intervention for Neurodegenerative Delay(MIND) on Cognitive Performance, Metabolic Health and Lifestyle Outcomes Using Advanced Machine Learning Strategies
The goal of this clinical trial is to learn if increasing adherence to a Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet pattern improves brain and heart health relative to a healthy control diet in middle-aged adults. Our research team will evaluate three different groups: the first group will be chosen using a predictive analytics model that predicts who will benefit most from the MIND diet, the second group will follow the MIND diet without being pre-selected, and the third group will eat a standard healthy diet to serve as a comparison.
The main questions it aims to answer are:
Read more
Does the MIND diet improve cognitive performance and heart health relative to a control diet? How does the health impact of the MIND diet in participants pre-identified through predictive analytics compare to those without such pre-selection? Which of the three groups - predictive analytics selected MIND diet group, standard MIND diet group, or healthy control - demonstrate the most significant improvements in cognitive and cardiovascular health over the course of the trial?
Participants will:
Consume one meal that follows the MIND diet or a control meal every day for 3 months. Visit the lab before and after the 3 months of meals for tests. Keep a record of the food they eat during the study.
Read the detailed description
The purpose of this study is to understand how a healthy diet is related to thinking ability and heart health. Participants will be asked to consume a microwaveable study meal or prepackaged smoothie every day for 12 weeks. These meals will be delivered to participant homes using Daily Harvest meal delivery service. The study meals and smoothies will follow either a dietary pattern thought to improve brain and heart health (MIND), or a control diet, and will include foods commonly found in grocery stores. Participants will not know which diet they are assigned to (active or control). Participants will also be asked to follow simple dietary guidance on a healthy diet in addition to the meals provided. Participants will complete a series of online forms or surveys. Additionally, participants will come to 4 in-person laboratory visits to complete several computer-based tests of memory and attention while wearing an EEG cap. Participants will also be asked to complete an eye test, a heart rate and blood pressure assessment, a bone and body scan called DXA, and a blood draw at the beginning of the study and again at the end of the 12-week diet period.
- Being tested
- MIND Diet, Control Diet
- Keywords
- Executive function, MIND, Dietary Pattern
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIND DietOther
Daily meals designed to increase adherence to the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) dietary pattern.
Control DietOther
Daily meals designed to increase fruit, vegetable, and whole grain intake consistent with a healthy American diet.
| Study group | Role | What they receive |
|---|---|---|
| Standard MIND diet | Experimental | 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. Receives: Other: MIND Diet |
| Predictive Analytics informed MIND Diet | Experimental | 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. Receives: Other: MIND Diet |
| Control Diet | Active comparator | 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). Receives: Other: Control Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attentional Accuracy
Changes in accuracy (%) between groups using a computerized flanker task.
Measured: [Time Frame: 12 weeks (Baseline vs Follow-Up)]
Attentional Reaction Time
Changes in reaction time (ms) between groups using a computerized flanker task.
Measured: [Time Frame: 12 weeks (Baseline vs Follow-Up)]
Attentional Resource Allocation
Changes in P3 event related potential amplitude (microvolts) between groups using a computerized flanker task.
Measured: [Time Frame: 12 weeks (Baseline vs Follow-Up)]
Attentional Processing Speed
Changes in P3 event related potential latency (ms) between groups using a computerized flanker task.
Measured: [Time Frame: 12 weeks (Baseline vs Follow-Up)]
Fasting Blood Glucose
Changes in fasting blood glucose concentration (mg/dL) between groups.
Measured: [Time Frame: 12 weeks (Baseline vs Follow-Up)]
Fasting Blood Triglycerides
Changes in fasting blood triglyceride concentration (mg/dL) between groups.
Measured: [Time Frame: 12 weeks (Baseline vs Follow-Up)]
Fasting Blood HDL
Changes in fasting blood HDL concentration (mg/dL) between groups.
Measured: [Time Frame: 12 weeks (Baseline vs Follow-Up)]
Blood Pressure
Changes in systolic and diastolic blood pressure (mmHg) between groups
Measured: [Time Frame: 12 weeks (Baseline vs Follow-Up)]
Waist Circumference
Changes in waist circumference (cm) between groups.
Measured: [Time Frame: 12 weeks (Baseline vs Follow-Up)]
Secondary outcomes (2)
Macular Pigment Optical Density
Changes in Macular Pigment Optical Density (log units) between groups using a macular densitometer.
Measured: [Time Frame: 12 weeks (Baseline vs Follow-Up)]
Visceral Adipose Tissue
Changes in visceral adipose tissue (g) between groups using Dual X-ray Absorptiometry.
Measured: [Time Frame: 12 weeks (Baseline vs Follow-Up)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start3 Jul 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ChangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naiman Khan, University of Illinois at Urbana-Champaign
- Investigators
- Naiman Khan, PhD, Principal investigator, University of Illinois Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06605898
- Sponsor's protocol ID
- OPTIMAL
- Status last verified
- Sep 2024
- First submitted
- 18 Sep 2024
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimized Tailored Interventions in Metabolic and Lifestyle Outcomes: Examining the Effects of the Mediterranean-DASH Intervention for Neurodegenerative Delay(MIND) on Cognitive Performance, Metabolic Health and Lifestyle Outcomes Using Advanced Machine Learning Strategies
- ClinicalTrials.gov ID
- NCT06605898
- Acronym / sponsor ID
- OPTIMAL
- Keywords
- Executive function, MIND, Dietary Pattern
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- 3 Jul 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if increasing adherence to a Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet pattern improves brain and heart health relative to a healthy control diet in middle-aged adults. Our research team will evaluate three different groups: the first group will be chosen using a predictive analytics model that predicts who will benefit most from the MIND diet, the second group will follow the MIND diet without being pre-selected, and the third group will eat a standard healthy diet to serve as a comparison.
The main questions it aims to answer are:
Does the MIND diet improve cognitive performance and heart health relative to a control diet? How does the health impact of the MIND diet in participants pre-identified through predictive analytics compare to those without such pre-selection? Which of the three groups - predictive analytics selected MIND diet group, standard MIND diet group, or healthy control - demonstrate the most significant improvements in cognitive and cardiovascular health over the course of the trial?
Participants will:
Consume one meal that follows the MIND diet or a control meal every day for 3 months. Visit the lab before and after the 3 months of meals for tests. Keep a record of the food they eat during the study.
Detailed description
The purpose of this study is to understand how a healthy diet is related to thinking ability and heart health. Participants will be asked to consume a microwaveable study meal or prepackaged smoothie every day for 12 weeks. These meals will be delivered to participant homes using Daily Harvest meal delivery service. The study meals and smoothies will follow either a dietary pattern thought to improve brain and heart health (MIND), or a control diet, and will include foods commonly found in grocery stores. Participants will not know which diet they are assigned to (active or control). Participants will also be asked to follow simple dietary guidance on a healthy diet in addition to the meals provided. Participants will complete a series of online forms or surveys. Additionally, participants will come to 4 in-person laboratory visits to complete several computer-based tests of memory and attention while wearing an EEG cap. Participants will also be asked to complete an eye test, a heart rate and blood pressure assessment, a bone and body scan called DXA, and a blood draw at the beginning of the study and again at the end of the 12-week diet period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard MIND diet | Experimental | Other: MIND DietParticipants 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. |
| Predictive Analytics informed MIND Diet | Experimental | Other: MIND DietParticipants 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. |
| Control Diet | Active comparator | Other: Control DietParticipants 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). |
Who may qualify
- Ages
- 45 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 45-64 years of age
- 20/20 or corrected vision
- No food allergies or intolerances
- Not pregnant, lactating, or have given birth in the past 12 months
- Do not smoke, use tobacco, or abuse drugs
Key exclusion criteria (12 listed)
- Non-consent of participant
- Above 64 or below 45 years of age
- Vision not 20/20 or corrected
- Food allergies or intolerances
- Pregnant, lactating, or have given birth in the past 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MIND DietDaily meals designed to increase adherence to the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) dietary pattern. | Other | Predictive Analytics informed MIND Diet, Standard MIND diet |
| Control DietDaily meals designed to increase fruit, vegetable, and whole grain intake consistent with a healthy American diet. | Other | Control Diet |
Primary outcome
Attentional Accuracy
Time frame: [Time Frame: 12 weeks (Baseline vs Follow-Up)]
Changes in accuracy (%) between groups using a computerized flanker task.
Attentional Reaction Time
Time frame: [Time Frame: 12 weeks (Baseline vs Follow-Up)]
Changes in reaction time (ms) between groups using a computerized flanker task.
Attentional Resource Allocation
Time frame: [Time Frame: 12 weeks (Baseline vs Follow-Up)]
Changes in P3 event related potential amplitude (microvolts) between groups using a computerized flanker task.
Attentional Processing Speed
Time frame: [Time Frame: 12 weeks (Baseline vs Follow-Up)]
Changes in P3 event related potential latency (ms) between groups using a computerized flanker task.
Fasting Blood Glucose
Time frame: [Time Frame: 12 weeks (Baseline vs Follow-Up)]
Changes in fasting blood glucose concentration (mg/dL) between groups.
Fasting Blood Triglycerides
Time frame: [Time Frame: 12 weeks (Baseline vs Follow-Up)]
Changes in fasting blood triglyceride concentration (mg/dL) between groups.
Fasting Blood HDL
Time frame: [Time Frame: 12 weeks (Baseline vs Follow-Up)]
Changes in fasting blood HDL concentration (mg/dL) between groups.
Blood Pressure
Time frame: [Time Frame: 12 weeks (Baseline vs Follow-Up)]
Changes in systolic and diastolic blood pressure (mmHg) between groups
Waist Circumference
Time frame: [Time Frame: 12 weeks (Baseline vs Follow-Up)]
Changes in waist circumference (cm) between groups.
2 secondary outcomes
Macular Pigment Optical Density
Time frame: [Time Frame: 12 weeks (Baseline vs Follow-Up)]
Visceral Adipose Tissue
Time frame: [Time Frame: 12 weeks (Baseline vs Follow-Up)]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Naiman Khan, PhD principal investigator
University of Illinois Urbana-Champaign
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MIND Diet in people with Cognitive Change and Diet, Healthy, run by University of Illinois at Urbana-Champaign at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Naiman Khan, PhD (2173001667, nakhan2@illinois.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attentional Accuracy (time frame: [Time Frame: 12 weeks (Baseline vs Follow-Up)]). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024.