Mild Cognitive ImpairmentNCT02521818
Dietary Treatments for Cognitive Impairment in Older Adults
A study testing Modified Atkins Diet and NIA Diet for Seniors in people with Mild Cognitive Impairment and Probable Alzheimer's Disease, run by Johns Hopkins University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Mild Cognitive Impairment, Probable Alzheimer's Disease
- What is being tested?
- Modified Atkins Diet and NIA Diet for Seniors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to 1 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of mild cognitive impairment or Alzheimer's disease
- availability of cohabitating study partner without cognitive impairment
- consent of primary care physician
Who cannot join
- 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
Show all 10Show fewer
- insulin-dependent diabetes
- body mass index <18.5
- multiple food allergies
- follow strict diet (e.g., vegetarian, gluten-free)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- Modified Atkins Diet, NIA Diet for Seniors
- Keywords
- cognition, dementia, neuropsychological, elderly, nutrition, diet
- Medical subject headings
- Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Atkins DietOther
Also called ketogenic diet
NIA Diet for SeniorsOther
| Study group | Role | What they receive |
|---|---|---|
| Modified Atkins Diet | Experimental | modified Atkins diet; fewer than 20 mg. carbohydrates per day, supplemented by extra dietary fats Receives: Other: Modified Atkins Diet |
| NIA Diet for Seniors | Active comparator | Diet recommended by NIA for seniors Receives: Other: NIA Diet for Seniors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility for MAD Group
Achieving moderate ketosis (>=40 mg.dl) at 3 consecutive follow-up visits
Measured: 12 weeks
Feasibility for Control Group
Achieving a Healthy Eating Index (>=85) at 3 consecutive follow-up visits
Measured: 12 weeks
Secondary outcomes (2)
Efficacy for Cognition
Composite Memory Score (mean z-score on delayed recall of HVLT-R and BVMT-R)
Measured: 12 weeks
Efficacy for Function
Change in MDS-HC Instrumental Activities of Daily Living Score
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startAug 2015
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason Brandt, Ph.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02521818
- Sponsor's protocol ID
- IRB00066092
- Status last verified
- Sep 2019
- First submitted
- 10 Aug 2015
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Efficacy of Dietary Interventions for Cognitive Impairment in Older Adults
- ClinicalTrials.gov ID
- NCT02521818
- Acronym / sponsor ID
- IRB00066092
- Keywords
- cognition, dementia, neuropsychological, elderly, nutrition, diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 13 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified Atkins Diet | Experimental | Other: Modified Atkins Dietmodified Atkins diet; fewer than 20 mg. carbohydrates per day, supplemented by extra dietary fats |
| NIA Diet for Seniors | Active comparator | Other: NIA Diet for SeniorsDiet recommended by NIA for seniors |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of mild cognitive impairment or Alzheimer's disease
- availability of cohabitating study partner without cognitive impairment
- consent of primary care physician
Key exclusion criteria (10 listed)
- history of stroke
- history of coronary artery disease
- history of pancreatitis
- untreated hypothyroidism or B12 deficiency
- history of renal disease or recurrent kidney stones
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Atkins DietAlso: ketogenic diet | Other | Modified Atkins Diet |
| NIA Diet for Seniors | Other | NIA Diet for Seniors |
Primary outcome
Feasibility for MAD Group
Time frame: 12 weeks
Achieving moderate ketosis (>=40 mg.dl) at 3 consecutive follow-up visits
Feasibility for Control Group
Time frame: 12 weeks
Achieving a Healthy Eating Index (>=85) at 3 consecutive follow-up visits
2 secondary outcomes
Efficacy for Cognition
Time frame: 12 weeks
Efficacy for Function
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Brandt, Ph.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Atkins Diet and NIA Diet for Seniors in people with Mild Cognitive Impairment and Probable Alzheimer's Disease, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility for MAD Group (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019.