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

NCT02463084 | Completed DMC

• 1 other identifier: IRB 00022512
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Prediabetic State; Insulin Resistance; Middle Age; Prehypertension; Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Change in cerebrospinal fluid levels of Alzheimer's disease biomarkers (CSF beta-amyloid 42)

  CSF beta-amyloid 42

  After 4 week diet intervention

Secondary Outcomes (5)

• Changes in brain structure

  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)

  After 4 week diet intervention

• Changes in cognition (Change in delayed memory and executive function composites)

  After 4 week diet intervention

• Change in brain function as measured by MRI

  After 4 week diet intervention

• Change in brain perfusion

  After 4 week diet intervention

Study Arms (2)

Low Diet

EXPERIMENTAL

Diet intervention consisting of foods with low saturated fats, low glycemic index and low salt

Other: Low Diet

High Diet

EXPERIMENTAL

Diet intervention consisting of foods with high saturated fats, high glycemic index and high salt

Other: High Diet

Interventions

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.

Low Diet

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.

High Diet

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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:
• HMG-CoA Reductase Inhibitors \[Statins: Atorvastatin (Lipitor), Fluvastatin (Lescol or Lescol EX), Lovastatin, Pravastatin (Pravachol), Rosuvastatin (Crestor), Simvastatin (Zocor)\]
• Bile Acid Resins \[Cholestyramine (Questran), Colestipol, Colesevelam (Welchol)\]
• Fibric Acids Derivatives \[Fenofibrate (Tricor), Gemfibrozil\]
• Combinations \[Amlodipine/Atorvastatin, Niacin/Lovastatin (Advicor), Ezetimibe/Simvastatin (Vytorin)\]
• Miscellaneous Categories \[Ezetimibe (Zetia), Niacin aka Nicotinic acid (Niaspan)

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Prediabetic State; Insulin Resistance; Prehypertension; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Suzanne Craft, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2014
• First Posted: June 4, 2015
• Study Start: March 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 9, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)