Macronutrient Effects on Alzheimer's Disease (MEAL-2)



Status:Completed
Conditions:Alzheimer Disease, Cognitive Studies, Cognitive Studies, High Blood Pressure (Hypertension), Endocrine, Diabetes
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology, Neurology, Psychiatry / Psychology
Healthy:No
Age Range:45 - 65
Updated:8/11/2018
Start Date:March 2013
End Date:June 2016

Use our guide to learn which trials are right for you!

Macronutrient Effects on Alzheimer's Disease: HTN and IR (Hypertension and Insulin Resistance) (MEAL-2)

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.


Inclusion Criteria:

1. Subjects will be middle-aged (45 to 65 years of age) and will fall on the continuum
from healthy (no pre-hypertension or insulin resistance) to pre-hypertensive and
insulin resistant (pHAIR).

2. Subjects will not be recruited based on memory status but will have normal memory or
memory impairment with a diagnosis of mild cognitive impairment (MCI). Those subjects
with MCI will have been assessed by physician and neuropsychologist experts and
diagnosed with MCI according to Petersen criteria.

Exclusion Criteria:

1. Diabetes not controlled by diet or exercise; current or previous use of diabetes
medications

2. Average systolic blood pressure on three occasions <90 or >139 mm/Hg, diastolic blood
pressure <60, or current use of anti-hypertensive medications;

3. Clinically significant elevations in liver function tests as follows: SGOT > 1.5 X
ULN, SGPT > 1.5 X ULN, Alkaline Phosphate > 1.5 ULN.

4. Clinically significant elevations in lipid profile as follows: LDL>190,
triglycerides>340, or total cholesterol>260 and LDL/HDL ratio >3.0.

5. 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;

6. Significant medical illness or organ failure, such as uncontrolled hypertension or
cardiovascular disease, chronic obstructive pulmonary disease, liver disease, or
kidney disease;

7. Current use of antipsychotic, anti-depressant, anti-convulsant, anticoagulant,
anxiolytic, or sedative medications;

8. Current use of cognition-enhancing medications;

9. Current use of glucocorticoids;

10. Current use of cholesterol-lowering medications, including:

1. HMG-CoA Reductase Inhibitors [Statins: Atorvastatin (Lipitor), Fluvastatin
(Lescol or Lescol EX), Lovastatin, Pravastatin (Pravachol), Rosuvastatin
(Crestor), Simvastatin (Zocor)]

2. Bile Acid Resins [Cholestyramine (Questran), Colestipol, Colesevelam (Welchol)]

3. Fibric Acids Derivatives [Fenofibrate (Tricor), Gemfibrozil]

4. Combinations [Amlodipine/Atorvastatin, Niacin/Lovastatin (Advicor),
Ezetimibe/Simvastatin (Vytorin)]

5. Miscellaneous Categories [Ezetimibe (Zetia), Niacin aka Nicotinic acid (Niaspan)

6. Over-the-counter [Red yeast rice, Niacinamide, Omega 3 fatty acids (fish or flax
seed), Slo-Niacin]

11. 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.

12. BMI ≤ 18.5

13. Current weight <110 pounds

14. 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.

15. If female, menstruation in the past 12 months or hysterectomy and current hormone
replacement therapy medication.

16. 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
We found this trial at
1
site
Winston-Salem, North Carolina 27157
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials