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Completed

NCT Number: NCT01820663

Dietary Intervention With the Modified Atkins Diet in Stroke Rehabilitation

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Burke Rehabilitation Hospital

White Plains, New York, 10605, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Modified Atkins diet

Other

A high fat, high protein, low- carbohydrate diet

Control diet

Other

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

Primary outcomes

  1. Change in Upper Extremity Fugl Meyer Motor Score

    Time frame: assessed upon beginning of the study, discharge from Burke Rehabilitation Hospital (average 25 days post study enrollment) and at 3 months post discharge

    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.

Secondary outcomes

  1. Change in Montreal Cognitive Assessment (MOCA)

    Time frame: assessed upon beginning of the study, discharge from Burke Rehabilitation Hospital (average 25 days post study enrollment) and at 3 months post discharge

    The MOCA is an assessment of cognitive impairment and evaluates several cognitive domains.

Sponsors and collaborators

Lead sponsor

Burke Rehabilitation Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 29, 2013
Registry last updated
Feb 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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