This study is NOT currently recruiting participants.
Number
15-AG-0123
Sponsoring Institute
National Institute on Aging (NIA)
Recruitment Detail
Type: Completed Study; data analyses ongoing Gender: Male & Female Min Age: 55 Years Max Age: 70 Years
Referral Letter Required
No
Population Exclusion(s)
Children
Keywords
Biomarkers; Diabetes; Obesity; Dementia of the Alzheimer Type; Functional Magnetic Resonance Imaging (fMRI)
Recruitment Keyword(s)
None
Condition(s)
Alzheimer's Disease; Obesity; Diabetes Mellitus
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Other: Boost (R) 5-2 diet Other: Healthy Living Diet
Supporting Site
National Institute on Aging
- Insulin removes sugar from the blood to use for energy. Insulin resistance means that cells may not respond to insulin normally. It can lead to serious diseases. Researchers want to see how diet affects insulin resistance, weight, and brain chemicals related to Alzheimer s disease.
Objectives:
- To compare two forms of diet and their effects on insulin resistance and the brain.
Eligibility:
- Women ages 55 70 with insulin resistance.
Design:
- This study requires 6 clinic visits over 9 12 weeks. Participants must fast before visits.
- Visit 1, screening:
- Medical history, physical exam, and blood and urine tests.
- Participants will get a wrist device to wear for 4 days.
- Visit 2:
- Weight and waist measurement.
- Blood drawn.
- Questionnaires and thinking tests.
- Lumbar puncture. Skin will be numbed and a needle inserted between bones in the back will remove <TAB>fluid.
- Participants will drink a nutrition shake. Blood will be taken 12 times over 4 <TAB>hours through a thin tube in <TAB>the arm.
- Brain MRI. Participants will lie on a table that slides in and out of a cylinder in a strong magnetic field. <TAB>They will have a coil on their head and may do tasks.
- Participants will get advice about healthy eating and be randomly put in one of 2 groups. One group will get <TAB>nutrition shakes to drink.
- Visits 3 5:
- Weight and waist measurements, vital signs, blood draw, and questionnaires.
- Between visits, participants will get a call or email to check how they are doing.
- Visit 6: Repeat of visit 1.
- Participants will wear the wrist device for 4 more days, have a follow-up contact, then the study is finished.
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INCLUSION CRITERIA: -BMI greater than or equal to 27; in addition, weight less than or equal to 350 lbs (weight limit for MRI scanner); -Age of 55-70 years; -HOMA-IR greater than or equal to 1.8; -MMSE greater than or equal to 26 EXCLUSION CRITEIRA: -History of clinically significant cardiovascular disease for the purpose of this study, such as chronic heart failure, coronary disease, cardiomyopathy, clinically significant cardiac valvular disease or clinically significant peripheral vascular disease. Cardiovascular conditions that are clinically non-significant for the purpose of this study, such as controlled hypertension, minor EKG abnormalities, mitral valve prolapse or benign murmurs are permissible; -History of clinically significant stroke or other neurological disease of the central nervous system; -History of substance abuse in the past 6 months or positive urine drug screen; -History of clinically significant endocrine disorders (common mild endocrine disorders, such as untreated subclinical hypothyroidism with TSH < 10 mU/l or successfully treated hypothyroidism may be allowed); -History of eating disorders, significant GI disorders or malabsorption disorders; -History of type 2 diabetes; and/or use of anti-diabetes medications or insulin; and/or type 2 diabetes diagnosed during the screening visit based on fasting glucose > 125 mg/dL; -History of hypoglycemia; and/or a fasting glucose < 70 mg/dL during the screening visit. -Current use of systemic corticosteroids; -Positive screening tests for HIV, HCV or HBV; -Hematocrit less than 35% or hemoglobin less than 11 mg/dL; -ALT or AST > 1.5 times the upper normal limit; -Contraindications for MRI (pacemakers, ferrous metal implants or shrapnel in or around the head, etc.). -Contraindications to LP, such as Coumadin, coagulopathy (international normalized ratio, or INR > 1.5; prothrombin time (PT), partial prothrombin time (PTT) > 1.5 x upper normal limit). Aspirin 81 mg qd is allowed. Aspirin up to 325 mg qd is allowed, if withheld for 7 days prior to the LP. -Pregnancy or nursing. -Refusal to consent to genetic testing for APOE.
-BMI greater than or equal to 27; in addition, weight less than or equal to 350 lbs (weight limit for MRI scanner);
-Age of 55-70 years;
-HOMA-IR greater than or equal to 1.8;
-MMSE greater than or equal to 26
EXCLUSION CRITEIRA:
-History of clinically significant cardiovascular disease for the purpose of this study, such as chronic heart failure, coronary disease, cardiomyopathy, clinically significant cardiac valvular disease or clinically significant peripheral vascular disease. Cardiovascular conditions that are clinically non-significant for the purpose of this study, such as controlled hypertension, minor EKG abnormalities, mitral valve prolapse or benign murmurs are permissible;
-History of clinically significant stroke or other neurological disease of the central nervous system;
-History of substance abuse in the past 6 months or positive urine drug screen;
-History of clinically significant endocrine disorders (common mild endocrine disorders, such as untreated subclinical hypothyroidism with TSH < 10 mU/l or successfully treated hypothyroidism may be allowed);
-History of eating disorders, significant GI disorders or malabsorption disorders;
-History of type 2 diabetes; and/or use of anti-diabetes medications or insulin; and/or type 2 diabetes diagnosed during the screening visit based on fasting glucose > 125 mg/dL;
-History of hypoglycemia; and/or a fasting glucose < 70 mg/dL during the screening visit.
-Current use of systemic corticosteroids;
-Positive screening tests for HIV, HCV or HBV;
-Hematocrit less than 35% or hemoglobin less than 11 mg/dL;
-ALT or AST > 1.5 times the upper normal limit;
-Contraindications for MRI (pacemakers, ferrous metal implants or shrapnel in or around the head, etc.).
-Contraindications to LP, such as Coumadin, coagulopathy (international normalized ratio, or INR > 1.5; prothrombin time (PT), partial prothrombin time (PTT) > 1.5 x upper normal limit). Aspirin 81 mg qd is allowed. Aspirin up to 325 mg qd is allowed, if withheld for 7 days prior to the LP.
-Pregnancy or nursing.
-Refusal to consent to genetic testing for APOE.
Principal Investigator
Referral Contact
For more information: