Clinical trial NCT01820663: Dietary Intervention With the Modified Atkins Diet in Stroke Rehabilitation
Official title: Dietary Intervention in Stroke Recovery in the Acute Rehabilitation Setting With the Modified Atkins Diet.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Stroke
Ischemic Stroke
Keywords: stroke
ketones
ketogenic diet
impairment
disability
Lead sponsor: Burke Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2013-03-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This phase 1 study tests whether use of the Modified Atkins Diet (MAD) can improve motor impairment after stroke. It is based on the hypothesis that after stroke, the brain's utilization of glucose, it's primary source of energy, is disrupted. The MAD is a low-carbohydrate diet that has can switch the body's metabolism from using glucose to using products of fat metabolism, so-called ketones. Ketones may act as an alternative energy substrate for the brain. Ketones also have several neuroprotective effects after stroke.


Eligibility criteria: Inclusion Criteria:

* Age 18-99
* First time unilateral hemispheric ischemic stroke. Not more than 12 weeks after acute stroke.
* Burke Stroke Rehabilitation Unit Inpatient.
* Preserved cognitive ability to understand commands and participate in outcome measures and to give informed consent. In patients with aphasia, cognitive ability to give consent will be determined by a physician.
* Upper extremity motor impairment with an UE Fugl Meyer score ≤ 56/66
* Independence in ADLS/ absence of major impairment prior to stroke

Exclusion Criteria:

* Hemorrhagic stroke
* Uncontrolled hyperlipidemia with LDL \> 250 on admission
* Uncontrolled Diabetes mellitus with BS \> 300 averaged over the first day of admission
* Nutritional risk as defined by BMI \< 18.5 or by a score of 2 or higher on the Malnutrition Universal Screening Tool (scores BMI, % of unplanned weight loss in last 3-6 months and question whether patient is acutely ill)
* Decreased renal function with eGFR \<30%
* Stage III and IV pressure ulcers
* Osteoporosis not sufficiently treated with oral Calcium and Vitamin D supplements
* CHF as defined by class III or worse
* Hypersensitivity/allergy to cholesterol lowering medications
* H/o kidney stones within last 1 year prior to stroke or medications predisposing to kidney stones such as Topamax, carboanhydrase inhibitors
* Inability to tolerate an oral diet and need for tube feeds
* Active enrollment in any other interventional studies at Burke; enrollment in observational studies or studies using TMS as a measurement may not pose exclusion criteria
* Cognitively unable to follow instructions.

Primary outcomes:
measure: Change in Upper Extremity Fugl Meyer Motor Score
timeFrame: assessed upon beginning of the study, discharge from Burke Rehabilitation Hospital (average 25 days post study enrollment) and at 3 months post discharge
Secondary outcomes:
measure: Change in Montreal Cognitive Assessment (MOCA)
timeFrame: assessed upon beginning of the study, discharge from Burke Rehabilitation Hospital (average 25 days post study enrollment) and at 3 months post discharge
Other outcomes:
Locations:
city: White Plains
country: United States
facility: Burke Rehabilitation Hospital
state: New York
Study officials:
affiliation: Burke Rehabilitation Hospital
name: Carolin I Dohle, MD
role: PRINCIPAL_INVESTIGATOR
References: