Start: May 8, 2019
End: December 2021
What Is This Study About?
Problems with blood sugar metabolism, known as metabolic dysfunction, increase risk for Alzheimer's disease and affect memory and related brain function. This study will test intermittent calorie restriction as a way to reduce metabolic dysfunction in older adults with mild cognitive impairment (MCI), a precursor to Alzheimer's disease, who are overweight or obese. Participants will be randomly assigned to the intervention or comparative group. The intervention group will consume one 530-calorie protein shake, with enough nutrients to sustain the person, per day for two consecutive days each week. Participants will eat as they want during the remaining five days. Participants in both groups will meet with a registered dietitian nutritionist about dietary modifications to support moderate weight loss. Researchers will examine the effects of the intervention on weight loss, behavior, and brain function.
Do I Qualify To Participate in This Study?
- Body mass index of 28 to 39 and weight less than 350 pounds
- Mini-Mental State Examination score of 24 or greater
- Subjective memory concern from the participant, caregiver/informant, or a clinician
- Education-adjusted score for the Logical Memory II, paragraph A Wechsler Memory Scale (16 years: 8-10; 8 to 15 years: 5-7; 0 to 7 years: 2-3)
- Clinical Dementia Rating sum of boxes score of 0.5
- No deficits in activities of daily living
- Consensus confirmation of MCI by senior investigators
- Informant/caregiver that can attend study visits
Must NOT have:
- History of a major cardiovascular event (e.g., heart attack)
- History of cerebrovascular or other neurological disorders (e.g., stroke, epilepsy, multiple sclerosis)
- History of substance abuse in the past 6 months
- History of eating disorders
- History of clinically significant endocrine disorders (e.g., hypothyroidism)
- History of mood and anxiety disorders (e.g., major depressive disorder, generalized anxiety disorder, bipolar disorder)
- Prohibited medications: insulin, corticosteroids, warfarin, and Alzheimer's disease drugs (memantine, galantamine, donepezil, rivastigmine)
- Having smoked tobacco products in the last three months
- Contraindications for MRI (e.g., pacemakers, ferrous metal implants or shrapnel around the face or eyes)
- Other medical history that could introduce risk for participation
- High blood pressure, defined by a diastolic/systolic blood pressure greater than 160/110 mm Hg
If I Qualify, Who Do I Contact?
Contact study personnel listed either under the general study contact or the location nearest you.
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?
Lead: Iowa State University
National Institute on Aging (NIA)
Source: ClinicalTrials.gov ID: NCT03872375