Dietary Intervention With the Modified Atkins Diet in Stroke Rehabilitation

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Ischemic Stroke
• Intervention / Treatment: Other: Modified Atkins Diet; Other: Control diet

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • White Plains, New York, United States, 10605
      • Burke Rehabilitation Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Modified Atkins Diet; Patients will receive a 14 day menu consisting of the Modified Atkins diet, a low-carbohydrate, high protein, high fat diet.	Other: Modified Atkins Diet; A high fat, high protein, low- carbohydrate diet
Placebo Comparator: Control Diet; Patients will receive a diet (e.g. regular, low cholesterol, diabetic) determined by the attending physician.	Other: 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.; Other Names: Low sodium diet; low sodium/ low cholesterol diet; regular diet; diabetic diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Burke Rehabilitation Hospital
• Investigators: Principal Investigator: Carolin I Dohle, MD, Burke Rehabilitation Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: March 13, 2013
• First Submitted That Met QC Criteria: March 28, 2013
• First Posted (Estimate): March 29, 2013

Study Record Updates

• Last Update Posted (Estimate): February 24, 2016
• Last Update Submitted That Met QC Criteria: February 22, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: stroke; ketogenic diet; disability; ketones; impairment
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: BRH-424

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Individual Participant Data will not be disclosed.