Status:
COMPLETED
Calorie Restriction and Brain Function in Mild Cognitive Impairment
Lead Sponsor:
Iowa State University
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Mild Cognitive Impairment
Eligibility:
All Genders
70-85 years
Phase:
NA
Brief Summary
Problems with blood sugar metabolism (i.e., metabolic dysfunction) progressively develop through old age, which is primarily due to obesity and lack of physical activity. Metabolic dysfunction increas...
Detailed Description
AD diagnosis is projected to increase from approximately 5 million to 13.8 million Americans by 2050. The Alzheimer's Association estimates that healthcare costs for AD by 2050 could be 1.2 trillion d...
Eligibility Criteria
Inclusion
- Years of age 70-85;
- Body Mass Index =\> 28 and \< 40 and weight \< 350 pounds;
- Mini-Mental State Examination \>= 24;
- A subjective memory concern from the participant, caregiver/informant, or a clinician;
- An education-adjusted score for the Logical Memory II, paragraph A Wechsler Scale (16 years: 8-10; 8-15 years: 5-7; \< 0-7 years: 2-3);
- A Clinical Dementia Rating - sum of boxes = 0.5;
- No deficits in activities of daily living;
- Consensus confirmation of MCI by senior investigators;
- An informant/caregiver that is informed about the study and will be present at study visits.
Exclusion
- A history of a major cardiovascular event(e.g., heart attack);
- A history of cerebrovascular or other neurological disorders (e.g., stroke, epilepsy, multiple sclerosis, etc.);
- A history of substance abuse in the past 6 months;
- A history of eating disorders;
- A history of clinically significant endocrine disorders (e.g., hypothyroidism);
- A history of mood and anxiety disorders (e.g., Major Depressive Disorder, Generalized Anxiety Disorder, Bipolar disorder, etc.);
- Taking insulin;
- Current use of systemic corticosteroids;
- Current use of Warfarin;
- Having smoked tobacco products in the last 3 months;
- Contraindications for MRI (pacemakers, ferrous metal implants or shrapnel about the face or eyes, etc.);
- Other medical history that, in the opinion of the investigators, would constitute risk for subject participation;
- Hypertension, defined by a diastolic/systolic blood pressure of \> 160/110;
- No current use of memantine or other Alzheimer's disease drugs.
Key Trial Info
Start Date :
May 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT03872375
Start Date
May 8 2019
End Date
December 31 2021
Last Update
March 31 2022
Active Locations (2)
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1
Nutrition and Wellness Research Center
Ames, Iowa, United States, 50011
2
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242