Brain Energy for Amyloid Transformation in AD (BEAT-AD) Study

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 85
Healthy Volunteers: f
View:

• 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

Locations
United States
North Carolina
Wake Forest Baptist Medical Center
RECRUITING
Winston-salem
Contact Information
Primary
Karen Gagnon
Karen.Gagnon@Advocatehealth.org
(336) 713-8010
Backup
Lauren Latham
lauren.latham@advocatehealth.org
(336) 716-6317
Time Frame
Start Date: 2018-07-16
Estimated Completion Date: 2026-04
Participants
Target number of participants: 120
Treatments
Experimental: Modified Mediterranean Ketogenic Diet
The MMKD is a low carbohydrate/high fat diet aimed at inducing ketosis, as the experimental diet in the proposed study. Participants on the MMKD will keep their daily carbohydrate consumption below 20 grams per day throughout the 4 month intervention.The MMKD group will be supplied with extra virgin olive oil during their in person visits to use as a source of fat in their diet, and will be encouraged to eat plentiful fish, lean meats, and nutrient rich foods that meet the requirement of \<20 grams total carbohydrates per day.~Participants will receive a daily multivitamin (Centrum Silver) over the course of the study and instructed to take 1 tablet each day while on the diet.
Experimental: American Heart Association Diet
The American Heart Association Diet (AHAD), is a low fat/high carbohydrate diet (\<40 grams/day) will be used as the control diet. Participants on the AHAD will be encouraged to limit their amount of fat intake to \<40 grams/day, while eating plentiful fruits, vegetables, and carbohydrates containing adequate fiber. Participants will receive the same daily multivitamin supplement (Centrum Silver) over the course of the study and instructed to take 1 tablet each day while on the diet.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Aging (NIA)
Leads: Wake Forest University Health Sciences

This content was sourced from clinicaltrials.gov

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