Brain Energy for Amyloid Transformation in AD (BEAT-AD) Study
Wake Forest University Health Sciences
Summary
The Brain Energy for Amyloid Transformation in AD (Alzheimer's disease) or BEAT-AD study will compare the effects of a ketogenic low-carbohydrate diet and a low-fat diet in adults with mild cognitive impairment. The data collected will help determine whether diet interventions induce changes in cognitive function, cerebral blood flow, and levels of certain proteins and hormones in body fluids. The study will include volunteers who have mild cognitive impairment, who will be randomly assigned to receive either a ketogenic low-carbohydrate diet or a low-fat diet for 16-weeks, with follow-up assessment 8 weeks after diet completion. Study measures, clinic visits and phone sessions will occur at baseline and throughout the 24-week study. Participant will follow either a low-carbohydrate or low-fat diet that will be individually planned with help from a study dietitian. After completing the study diet for 16 weeks, participants will resume their normal diet. The final visits will occur at week 24 (8 weeks after the completing the diet). At the end of the 24-week study, participants will be given the opportunity to meet with the study dietitian for education and assistance with planning a healthy diet.
Description
This study will examine the effects of a 4-month Modified Mediterranean-Ketogenic Diet compared with an American Heart Association Diet (AHAD - a regimen that has been shown to reduce the risk for cardiovascular disease). We will investigate diet effects on AD biomarkers, on cognition, and on neuroimaging measures of blood flow. Our study will extend previous findings in several important ways by: 1) using a Modified Mediterranean-Ketogenic Diet rather than a traditional Ketogenic Diet, which has the potential for greater long-term compliance and health benefits; 2) increasing the sample size…
Eligibility
- Age range
- 55–85 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Diagnosis of amnestic mild cognitive impairment * An informant (study partner) able to provide collateral information on the participant * Stable medical condition (generally 3 months prior to screening visit) at the discretion of study physician * Stable on medications (generally 4 weeks prior to screening visit) at the discretion of study physician * Able to complete baseline assessments Exclusion Criteria: * Diagnosis of neurodegenerative illness (except for MCI); * History of a clinically significant stroke * Current evidence or history in past year of focal brain…
Interventions
- Otherlow carbohydrate/high fat diet
Modified Mediterranean-Ketogenic Diet is a low carbohydrate/high fat diet.
- Otherlow fat/high carbohydrate diet
American Heart Association Diet is a low fat/high carbohydrate diet.
Location
- Wake Forest Baptist Medical CenterWinston-Salem, North Carolina