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This study compares the effects of a one-month diet high in saturated fat (SF), glycemic index (GI), and salt (Na+) to a diet low in these nutritional parameters on memory and other cognitive functions, on MRI measures of brain structure, function, and perfusion, as well as on blood and cerebrospinal fluid levels of amyloid-beta (Aβ), insulin, lipids (total cholesterol, HDL, LDL, oxidized LDL, and triglycerides), cytokines, apolipoprotein E (ApoE), apolipoprotein J, cortisol, soluble low density lipoprotein receptor-related protein (sLRP), and glucose in middle-aged adults (45-65 years of age) with normal cognition or mild cognitive impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Diet | Experimental | Diet intervention consisting of foods with low saturated fats, low glycemic index and low salt |
|
| High Diet | Experimental | Diet intervention consisting of foods with high saturated fats, high glycemic index and high salt |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Diet | Other | a 28-day course of 3 meals per day plus 2 snack that are either low in saturated fats, glycemic index and salt. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in cerebrospinal fluid levels of Alzheimer's disease biomarkers (CSF beta-amyloid 42) | CSF beta-amyloid 42 | After 4 week diet intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in brain structure | MRI entorhinal cortex and white matter volume | After 4 week diet intervention |
| Changes in adipose tissue distribution (Change in dual energy x-ray absorptiometry (DEXA) scan and CT measures of central and subcutaneous body fat) |
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Inclusion Criteria:
Exclusion Criteria:
Diabetes not controlled by diet or exercise; current or previous use of diabetes medications
Average systolic blood pressure on three occasions <90 or >139 mm/Hg, diastolic blood pressure <60, or current use of anti-hypertensive medications;
Clinically significant elevations in liver function tests as follows: SGOT > 1.5 X ULN, SGPT > 1.5 X ULN, Alkaline Phosphate > 1.5 ULN.
Clinically significant elevations in lipid profile as follows: LDL>190, triglycerides>340, or total cholesterol>260 and LDL/HDL ratio >3.0.
Significant neurologic disease that might affect cognition, including AD (MCI will be allowed), stroke, Parkinson's disease, multiple sclerosis, or severe head injury with loss of consciousness > 30 minutes or with permanent neurologic sequelae;
Significant medical illness or organ failure, such as uncontrolled hypertension or cardiovascular disease, chronic obstructive pulmonary disease, liver disease, or kidney disease;
Current use of antipsychotic, anti-depressant, anti-convulsant, anticoagulant, anxiolytic, or sedative medications;
Current use of cognition-enhancing medications;
Current use of glucocorticoids;
Current use of cholesterol-lowering medications, including:
Common allergies/sensitivities to the following food products: dairy, wheat, gluten, tree nuts or peanuts, eggs, corn, seafood and soy. Other food sensitivities will be assessed on a case-by-case basis.
BMI ≤ 18.5
Current weight <110 pounds
Clinically significant iron deficiency: Hemoglobin <13.5 for white males, <12.2 for white females, <12.5 for black males, and <11.5 for black females.
If female, menstruation in the past 12 months or hysterectomy and current hormone replacement therapy medication.
Major digestive disorders, absorption issues, or surgeries, including bowel resection, inflammatory bowel diseases (Ulcerative colitis or Crohn's disease), or irritable bowel syndrome (IBS) with a tendency toward diarrhea](streamdown:incomplete-link)
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| Name | Affiliation | Role |
|---|---|---|
| Suzanne Craft, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D007333 | Insulin Resistance |
| D058246 | Prehypertension |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| High Diet | Other | a 28-day course of 3 meals per day plus 2 snack that are either high in saturated fats, glycemic index and salt. |
|
Change in DEXA and CT measures of central and subcutaneous body fat |
| After 4 week diet intervention |
| Changes in cognition (Change in delayed memory and executive function composites) | Change in delayed memory and executive function composites | After 4 week diet intervention |
| Change in brain function as measured by MRI | Change in resting state default mode network connectivity | After 4 week diet intervention |
| Change in brain perfusion | Change in cerebral perfusion | After 4 week diet intervention |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |