Dietary Intervention With the Modified Atkins Diet in Stroke Rehabilitation

Stroke Clinical Trial

Official title:

Dietary Intervention in Stroke Recovery in the Acute Rehabilitation Setting With the Modified Atkins Diet.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01820663
• Other study ID #: BRH-424
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 13, 2013
• Last updated: February 22, 2016
• Start date: March 2012
• Est. completion date: May 2014

Study information

• Verified date: February 2016
• Source: Burke Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke

Intervention

Other:
• Modified Atkins Diet
A high fat, high protein, low- carbohydrate diet
• Control diet
The control diet is a diet determined by the attending physician caring for the patient and may consist of either a low sodium diet, a low sodium/ low cholesterol diet, a regular diet or a diabetic diet.

Locations

Country	Name	City	State
United States	Burke Rehabilitation Hospital	White Plains	New York

Sponsors (1)

Lead Sponsor	Collaborator
Burke Rehabilitation Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Upper Extremity Fugl Meyer Motor Score	The Upper Extremity Fugl Meyer Motor Score is used to assess impairment in upper extremity function. Individuals are asked to complete a certain sequence of movements, and quality of movements is scored.	assessed upon beginning of the study, discharge from Burke Rehabilitation Hospital (average 25 days post study enrollment) and at 3 months post discharge	No
Secondary	Change in Montreal Cognitive Assessment (MOCA)	The MOCA is an assessment of cognitive impairment and evaluates several cognitive domains.	assessed upon beginning of the study, discharge from Burke Rehabilitation Hospital (average 25 days post study enrollment) and at 3 months post discharge	No