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

Not Applicable

Completed

• Conditions: Insulin Resistance; Mild Cognitive Impairment; Middle Age; Prehypertension; Prediabetic State
• Interventions: Other: High Diet; Other: Low Diet

• Registration Number: NCT02463084
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2014-12-19
• Study First Submitted QC: 2015-06-02
• Study First Posted: 2015-06-04
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-07
• Last Update Posted: 2018-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Diet	High Diet	Diet intervention consisting of foods with high saturated fats, high glycemic index and high salt
Low Diet	Low Diet	Diet intervention consisting of foods with low saturated fats, low glycemic index and low salt

Primary Outcome Measures

Name	Time	Method
Change in cerebrospinal fluid levels of Alzheimer's disease biomarkers (CSF beta-amyloid 42)	After 4 week diet intervention	CSF beta-amyloid 42

Secondary Outcome Measures

Name	Time	Method
Change in brain function as measured by MRI	After 4 week diet intervention	Change in resting state default mode network connectivity
Change in brain perfusion	After 4 week diet intervention	Change in cerebral perfusion
Changes in brain structure	After 4 week diet intervention	MRI entorhinal cortex and white matter volume
Changes in cognition (Change in delayed memory and executive function composites)	After 4 week diet intervention	Change in delayed memory and executive function composites
Changes in adipose tissue distribution (Change in dual energy x-ray absorptiometry (DEXA) scan and CT measures of central and subcutaneous body fat)	After 4 week diet intervention	Change in DEXA and CT measures of central and subcutaneous body fat

Trial Locations

Locations (1)

Wake Forest Baptist Health; 🇺🇸 Winston-Salem, North Carolina, United States