Biodistribution of [11C]Acetoacetate/[18F]Fluorodeoxyglucose Using Positron Emission Tomography (PET) Scanning
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|ClinicalTrials.gov Identifier: NCT03130036|
Recruitment Status : Completed
First Posted : April 26, 2017
Last Update Posted : August 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease Mild Cognitive Impairment||Other: Low-Carbohydrate Diet Other: Low-Fat Diet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Masking Description:||The PI and cognitive assessor were blinded as to diet condition.|
|Primary Purpose:||Basic Science|
|Official Title:||Biodistribution of [11C]Acetoacetate/[18F]Fluorodeoxyglucose in Subjects With Varying Risk Factors for Alzheimer's Disease and Subjects on a Ketogenic Diet|
|Actual Study Start Date :||June 9, 2015|
|Actual Primary Completion Date :||June 2017|
|Actual Study Completion Date :||June 2017|
Experimental: LOW-CARBOHYDRATE DIET
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
Participants assigned to the Modified Ketogenic-Mediterranean Diet will keep their carbohydrate consumption below 20 grams per day throughout the 6-week intervention.
Experimental: LOW-FAT 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 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.
- Brain biodistribution of [11C]AcAc/[18F]FDG [ Time Frame: 18 weeks ]Differences in brain glucose and acetoacetate metabolism and how this relates to cognitive performance, metabolism, and other measures.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03130036
|United States, North Carolina|
|Wake Forest School of Medicine|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Suzanne Craft, PhD||Wake Forest University Health Sciences|