RECRUITING

Optimized Tailored Interventions in Metabolic and Lifestyle Outcomes (OPTIMAL)

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Conditions

Cognitive ChangeDiet, HealthyMetabolic Syndrome, Protection AgainstExecutive functionMINDDietary Pattern

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-07-03
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06605898

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years to 64 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * 45-64 years of age
  2. * 20/20 or corrected vision
  3. * No food allergies or intolerances
  4. * Not pregnant, lactating, or have given birth in the past 12 months
  5. * Do not smoke, use tobacco, or abuse drugs
  6. * 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
  7. * Not currently taking oral hypoglycemic agents, or insulin
  8. * No history of malabsorptive or bariatric surgery
  9. * Cognitively intact with no prior diagnosis of neurological disease (i.e., mild cognitive impairment, Alzheimer's disease, vascular dementia, and/or Asperger's syndrome)
  10. * Able to consume the study meals
  11. * Not enrolled in another dietary, exercise, or medication study during the study.
  1. * Non-consent of participant
  2. * Above 64 or below 45 years of age
  3. * Vision not 20/20 or corrected
  4. * Food allergies or intolerances
  5. * Pregnant, lactating, or have given birth in the past 12 months
  6. * Smoke, use tobacco, or abuse drugs
  7. * 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
  8. * Currently taking oral hypoglycemic agents or insulin
  9. * History of malabsorptive or bariatric surgery
  10. * Cognitively impaired and/or prior diagnosis of neurological disease (i.e., mild cognitive impairment, Alzheimer's disease, vascular dementia, and/or Asperger's syndrome)
  11. * Unable to consume the study meals
  12. * Concurrent enrollment in another dietary, exercise, or medication study

Contacts and Locations

Study Contact

Naiman Khan, PhD
CONTACT
2173001667
nakhan2@illinois.edu

Principal Investigator

Naiman Khan, PhD
PRINCIPAL_INVESTIGATOR
University of Illinois Urbana-Champaign

Study Locations (Sites)

University of Illinois at Urbana-Champaign
Urbana, Illinois, 61801
United States

Collaborators and Investigators

Sponsor: University of Illinois at Urbana-Champaign

  • Naiman Khan, PhD, PRINCIPAL_INVESTIGATOR, University of Illinois Urbana-Champaign

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-03
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2024-07-03
Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

  • Executive function
  • MIND
  • Dietary Pattern

Additional Relevant MeSH Terms

  • Cognitive Change
  • Diet, Healthy
  • Metabolic Syndrome, Protection Against