Dietary Treatments for Cognitive Impairment in Older Adults
| Status: | Recruiting |
|---|---|
| Conditions: | Alzheimer Disease, Cognitive Studies |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 60 - Any |
| Updated: | 9/30/2018 |
| Start Date: | August 2015 |
| End Date: | June 2019 |
| Contact: | Alison Buchholz, PhD |
| Email: | abuchho1@jhmi.edu |
| Phone: | 410-502-6352 |
Feasibility and Efficacy of Dietary Interventions for Cognitive Impairment in Older Adults
This trial seeks to establish the feasibility of implementing a ketogenic, modified Atkins
diet (MAD) to older adults with mild cognitive impairment (MCI) or early Alzheimer's disease
(AD) living in the community. A secondary aim is to determine whether adherence to the MAD
results in better cognitive test scores than adherence to a non-ketogenic control diet. A
final aim is to determine the role of apolipoprotein E (ApoE) genotype in participants'
response to the MAD. Participants will be randomly assigned to a 12-week trial of either the
MAD or a placebo diet based on the National Institute on Aging's recommendations for senior
nutrition.
diet (MAD) to older adults with mild cognitive impairment (MCI) or early Alzheimer's disease
(AD) living in the community. A secondary aim is to determine whether adherence to the MAD
results in better cognitive test scores than adherence to a non-ketogenic control diet. A
final aim is to determine the role of apolipoprotein E (ApoE) genotype in participants'
response to the MAD. Participants will be randomly assigned to a 12-week trial of either the
MAD or a placebo diet based on the National Institute on Aging's recommendations for senior
nutrition.
It is well established that Alzheimer's disease (AD) is associated with insulin resistance
and, hence, abnormal glucose metabolism. In fact, abnormalities in the brain's uptake of
glucose can be observed on PET imaging in advance of clinical symptoms. In patients with
established dementia due to AD, the severity of cognitive impairment is strongly correlated
with the decrease in glucose uptake. Ketone bodies, the products of fat metabolism, can serve
as a "backup" fuel when glucose is unavailable. Ketone body metabolism appears to bypass the
metabolic processes that are abnormal in AD and may provide better nourishment for neurons.
As a result, ketone body metabolism may slow cognitive decline or even improve cognition in
patients with AD.
Participants will be 60 people, age 60 or older, with MCI or mild probable AD and without
significant cardiovascular disease. They will be required to obtain the consent of their
primary care physicians for their participation. Each patient will have a study partner who
is cognitively healthy, lives with the participant, and can help him/her adhere to the diet.
A research dietitian will teach participants and partners the new diet and monitor
participants' adherence with food logs, in-person assessments, and urine ketone testing.
After an initial baseline visit, participants will complete four in-person assessments during
which adherence to the diet will be assessed and neurocognitive tests will be administered.
It is hypothesized that the MAD will be feasible and well tolerated by seniors with MCI and
AD. It is further hypothesized that adherence to the MAD will be associated with a greater
increase (or less decline) in cognitive test scores than the placebo diet, particularly for
those participants who do not carry an ApoE ε4 allele.
and, hence, abnormal glucose metabolism. In fact, abnormalities in the brain's uptake of
glucose can be observed on PET imaging in advance of clinical symptoms. In patients with
established dementia due to AD, the severity of cognitive impairment is strongly correlated
with the decrease in glucose uptake. Ketone bodies, the products of fat metabolism, can serve
as a "backup" fuel when glucose is unavailable. Ketone body metabolism appears to bypass the
metabolic processes that are abnormal in AD and may provide better nourishment for neurons.
As a result, ketone body metabolism may slow cognitive decline or even improve cognition in
patients with AD.
Participants will be 60 people, age 60 or older, with MCI or mild probable AD and without
significant cardiovascular disease. They will be required to obtain the consent of their
primary care physicians for their participation. Each patient will have a study partner who
is cognitively healthy, lives with the participant, and can help him/her adhere to the diet.
A research dietitian will teach participants and partners the new diet and monitor
participants' adherence with food logs, in-person assessments, and urine ketone testing.
After an initial baseline visit, participants will complete four in-person assessments during
which adherence to the diet will be assessed and neurocognitive tests will be administered.
It is hypothesized that the MAD will be feasible and well tolerated by seniors with MCI and
AD. It is further hypothesized that adherence to the MAD will be associated with a greater
increase (or less decline) in cognitive test scores than the placebo diet, particularly for
those participants who do not carry an ApoE ε4 allele.
Inclusion Criteria:
- diagnosis of mild cognitive impairment or Alzheimer's disease
- availability of cohabitating study partner without cognitive impairment
- consent of primary care physician
Exclusion Criteria:
- history of stroke
- history of coronary artery disease
- history of pancreatitis
- untreated hypothyroidism or B12 deficiency
- history of renal disease or recurrent kidney stones
- history of liver disease
- insulin-dependent diabetes
- body mass index <18.5
- multiple food allergies
- follow strict diet (e.g., vegetarian, gluten-free)
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