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Find more clinical trials

Intermittent Calorie Restriction, Insulin Resistance, and Brain Function

Start: June 2015
End: December 2022
Enrollment: 150

What Is This Study About?

Calorie restriction is defined as consuming fewer calories than what is considered normal without a lack of nutrients. This study will investigate how calorie restriction affects insulin resistance, weight, and brain chemicals related to Alzheimer's disease. The intervention group will adopt a 5-2 CR diet (500-600 calories a day for two consecutive days, followed by unrestricted eating for five days) for eight weeks. The control group will eat a normal, unrestricted diet. Both groups will receive dietary counseling at the start of the study. A visit at the beginning and end of the study will involve anthropometric measures, questionnaires, cognitive tests, a brain scan, blood draws, and lumbar puncture. Participants will visit the clinic every two weeks to be weighed and have a blood draw. Participants will wear an accelerometer, which measures physical activity, for 96 hours before and after they are on the diet.

Do I Qualify To Participate in This Study?

Minimum Age: 55 Years

Maximum Age: 70 Years

Must have:

  • Body mass index greater than or equal to 27
  • Weight less than or equal to 350 pounds
  • HOMA-IR greater than or equal to 1.8
  • Mini-Mental State Examination score greater than or equal to 26

Must NOT have:

  • History of cardiovascular disease, clinically significant stroke, or other neurological disease
  • History of substance abuse in the past six months or positive urine drug test
  • History of clinically significant endocrine disorders (common mild endocrine disorders or successfully treated hypothyroidism may be allowed)
  • History of eating disorders, significant gastrointestinal disorders, or malabsorption disorders
  • History of type 2 diabetes, use of diabetes medications or insulin, and/or type 2 diabetes diagnosed during screening
  • History of hypoglycemia and/or a fasting glucose level of <70 mg/dl during screening
  • 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 to MRI (such as pacemakers, ferrous metal implants, or shrapnel in or around the head)
  • Contraindications to lumbar puncture such as taking warfarin or coagulopathy; low-dose aspirin is allowed
  • Pregnancy or nursing
  • Refusal to consent to genetic testing

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

Need Help?

Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.

Where Is This Study Located?

Who Sponsors This Study?

Lead: National Institute on Aging (NIA)

Source: ClinicalTrials.gov ID: NCT02460783

alzheimers.gov

An official website of the U.S. government, managed by the National Institute on Aging at the National Institutes of Health