An interventional study of Low-Carbohydrate Diet and Low-Fat Diet in Mild Cognitive Impairment and Insulin Resistance, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 50 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-28.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Treatment
The purpose of the BEAM study is to compare the effects of a low-carbohydrate diet and a lowfat diet for adults with mild memory loss and adults with pre-diabetes. The data collected will help determine changes in cognitive function, brain structure and function, and levels of certain proteins and hormones in body fluids.
Participants will be enrolled into 1 of 3 study groups. Group 1 will include healthy volunteers with no apparent memory problems, memory complaints or family history of Alzheimer's disease or dementia. This group will complete cognitive assessments, blood and stool sample collection, neuroimaging, and lumbar puncture at week 0 only. Group 1 will NOT take part in the diet study.
Group 2 will have pre-diabetes, but no apparent memory problems that can be observed during cognitive testing. Group 2 will complete an 18-week diet study, with follow-up assessment 6 weeks after final diet completion. Throughout the study the following will also be completed; cognitive assessments, blood and stool sample collection, neuroimaging, and lumbar puncture.
Group 3 will have mild memory problems that are observed during cognitive testing. Group 3 will complete an 18-week diet study, with follow-up assessment 6 weeks after diet final completion. Throughout the study the following will also be completed; cognitive assessments, blood and stool sample collection, neuroimaging, and lumbar puncture.
3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.
This study's enrollment of 25 is below the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
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Exclusion Criteria:
The low-carbohydrate diet will consist of a meal plan of less than 20 grams of carbohydrates per day to be consumed over 6 weeks. Foods that provide high levels of healthy fats (preferably low in saturated fats) will be generously included in the diet plan. Various lean meats, fish, and nutrient rich foods that meet the requirement of less than 20 grams total carbohydrates per day will be included in the meal plans. Carbohydrates will be expected to make up less than 10% of total caloric intake. Participants in the low-carbohydrate diet group will receive a supply of extra virgin olive oil at study visits to incorporate into their individualized meal plans.
Other: Low-Carbohydrate Diet
The low-fat diet will consist of a low-fat, higher-carbohydrate meal plan to be consumed over 6 weeks. Participants will be encouraged to limit their amount of fat intake to less than 40 grams per day, while eating plentiful fruits, vegetables, and carbohydrates containing adequate fiber. Various lean meats and other sources of protein will be included in the diet plan. Carbohydrates will be expected to make up 50-60% of total caloric intake.
Other: Low-Fat Diet
Participants assigned to the Modified Ketogenic-Mediterranean Diet will keep their carbohydrate consumption below 20 grams per day throughout the 6-week intervention.
Participants assigned to the Low-Fat Diet will be encouraged to limit their amount of fat intake to \<40 grams/day, while eating plentiful fruits, vegetables, and carbohydrates containing adequate fiber.
Change in spinal fluid levels of biomarkers associated with Alzheimer's disease
Time frame: Baseline CSF measures will be compared to measures obtained six weeks after the initiation of the ketogenic diet and six weeks after initiation of the American Heart Association Diet
Change in memory composite score
Time frame: Baseline cognitive measures will be compared to measures obtained six weeks after the initiation of the ketogenic diet and six weeks after initiation of the American Heart Association Diet
Change in insulin sensitivity
Time frame: Baseline metabolic measures will be compared to measures obtained six weeks after the initiation of the ketogenic diet and six weeks after initiation of the American Heart Association Diet
change in 11C acetoacetate PET uptake
Time frame: Baseline acetoacetate uptake will be compared to measures obtained six weeks after the initiation of the ketogenic diet and six weeks after initiation of the American Heart Association Diet
Plan to share: No
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Wake Forest University Health Sciences