Evaluation of the Impact of a Dietary and Nutritional Intervention on Persistent Post-concussive Symptoms

Официальное название

Evaluation of the Impact of a Dietary and Nutritional Intervention on the Physical, Cognitive, Behavioural and Emotional Symptoms of Patients With Persistent Post-concussive Symptoms

Обзор

Concussions affect thousands of Canadians every year. Although the effects are usually temporary, 10-15% of adults experience persistent symptoms likely to last several weeks or even months. It is suggested that nutritional interventions should be considered in concussion management because nutrition can act on several mechanisms of brain injury. However, to date, no study has assessed the impact of dietary interventions on the recovery of people with persistent post-concussive symptoms. This randomized controlled trial aims to determine the impact of a dietary and nutritional intervention on the physical, cognitive, behavioural and emotional symptoms of patients with persistent post-concussive symptoms in New Brunswick, Canada. Patients will be randomized to one of three groups: 1) dietary treatments and nutritional supplements (experimental group A), 2) nutritional supplements (experimental group B), and 3) physiotherapy treatments (control group). Patients in group A will receive four consultations with a dietitian over eight weeks, in addition to conventional physiotherapy treatments. These patients will receive nutritional counselling and omega-3, vitamin D and creatine supplements. Patients in group B will be prescribed the same supplements as those in group A by their doctor and receive physiotherapy treatments. Finally, patients in the control group will only receive physiotherapy treatments. Patient symptoms will be measured using a questionnaire constructed from tools commonly used in practice. This questionnaire will be completed at the first physiotherapy session and 2, 4 and 8 weeks after the start of the intervention.

Подробное описание

Concussions affect thousands of Canadians every year. Although the effects are usually temporary, 10-15% of adults experience persistent symptoms likely to last several weeks or even months. Some studies have explored the impact of pharmaceuticals on treating post-concussive symptoms. Still, these have shown little success, leading the scientific community to consider multidisciplinary approaches to treating and managing concussions. Recently, it has been suggested that nutritional interventions should be considered in concussion management because nutrition can act on several mechanisms of brain injury. Some nutritional supplements have shown beneficial effects on the speed of recovery and the degree of severity of symptoms related to moderate or severe head trauma. Other studies have shown a link between malnutrition and low neurological and cognitive scores. However, to date, no study has assessed the impact of dietary interventions on the recovery of people with persistent post-concussive symptoms.

This randomized controlled trial aims to determine the impact of a dietary and nutritional intervention on the physical, cognitive, behavioural and emotional symptoms of patients with persistent post-concussive symptoms in New Brunswick, Canada. Patients will be randomized to one of three groups: 1) dietary treatments and nutritional supplements (experimental group A), 2) nutritional supplements (experimental group B), and 3) physiotherapy treatments (control group). Patients in group A will receive four consultations with a dietitian over eight weeks, in addition to conventional physiotherapy treatments. These patients will receive nutritional counselling and omega-3, vitamin D and creatine supplements. Patients in group B will be prescribed the same supplements as those in group A by their doctor and receive physiotherapy treatments. Finally, patients in the control group will only receive physiotherapy treatments. The use of three groups will help determine the individual impact of dietetic treatment offered by a dietitian and the use of supplements. Patient symptoms will be measured using a questionnaire constructed from tools commonly used in practice by medical doctors, physiotherapists and dietitians. This questionnaire will be completed at the first physiotherapy session and 2, 4 and 8 weeks after the start of the intervention.

Вмешательства

• Поведенческое Experimental: Dietetic counseling
  Patients will receive dietary counselling to increase caloric and nutrient intake, stabilize glycemia, and optimize hydration.
• Пищевая добавка Active Comparator: Omega-3, vitamin D3 and creatine monohydrate
  Patients will be prescribed dietary supplements which will be taken daily for 8 weeks, as per the supplement protocol.
• Поведенческое Other : Physiotherapy treatment
  Patients will receive weekly physiotherapy treatment.

Первичные конечные точки

• Change from baseline in severity of post-concussive symptoms at the end of the intervention [Срок оценки: Baseline and Endpoint (Week 8)]

Вторичные конечные точки (2)

• Change from baseline in balance at the end of the intervention [Срок оценки: Baseline and Endpoint (Week 8)]
• Change from baseline in vestibular ocular motor at the end of the intervention [Срок оценки: Baseline and Endpoint (Week 8)]

Критерии участия

Критерии включения

• 16 years or older
• Must be able to understand English or French
• Have persistent post-concussive symptoms lasting at least 2 weeks but no longer than 6 months

Критерии исключения

• <16 years old
• People who are breastfeeding, pregnant or plan to become pregnant in the next 2 months
• People with neurological disorders (other than concussion) or a history of moderate or severe brain injury
• People in an acute phase of an inflammatory bowel disease
• Any physical condition prohibiting a patient from receiving physiotherapy treatments

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Universite de Moncton — Moncton

Публикации

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• Aminmansour B, Nikbakht H, Ghorbani A, Rezvani M, Rahmani P, Torkashvand M, Nourian M, Moradi M. Comparison of the administration of progesterone versus progesterone and vitamin D in improvement of outcomes in patients with traumatic brain injury: A randomized clinical trial with placebo group. Adv Biomed Res. 2012;1:58. doi: 10.4103/2277-9175.100176. Epub 2012 Aug 28. PMID 23326789
• Annweiler C, Milea D, Whitson HE, Cheng CY, Wong TY, Ikram MK, Lamoureux EL, Sabanayagam C. Vitamin D insufficiency and cognitive impairment in Asians: a multi-ethnic population-based study and meta-analysis. J Intern Med. 2016 Sep;280(3):300-11. doi: 10.1111/joim.12491. Epub 2016 Apr 1. PMID 27037788
• Baltazar GA, Pate AJ, Panigrahi B, LaBoy S, Prosniak R, Mody A, Chendrasekhar A. Malnutrition as measured by albumin and prealbumin on admission is associated with poor outcomes after severe traumatic brain injury. Am Surg. 2015 Feb;81(2):E61-3. No abstract available. PMID 25642858
• Breck J, Bohr A, Poddar S, McQueen MB, Casault T. Characteristics and Incidence of Concussion Among a US Collegiate Undergraduate Population. JAMA Netw Open. 2019 Dec 2;2(12):e1917626. doi: 10.1001/jamanetworkopen.2019.17626. PMID 31851345
• Carney N, Totten AM, O'Reilly C, Ullman JS, Hawryluk GW, Bell MJ, Bratton SL, Chesnut R, Harris OA, Kissoon N, Rubiano AM, Shutter L, Tasker RC, Vavilala MS, Wilberger J, Wright DW, Ghajar J. Guidelines for the Management of Severe Traumatic Brain Injury, Fourth Edition. Neurosurgery. 2017 Jan 1;80(1):6-15. doi: 10.1227/NEU.0000000000001432. PMID 27654000
• Cekic M, Cutler SM, VanLandingham JW, Stein DG. Vitamin D deficiency reduces the benefits of progesterone treatment after brain injury in aged rats. Neurobiol Aging. 2011 May;32(5):864-74. doi: 10.1016/j.neurobiolaging.2009.04.017. Epub 2009 May 30. PMID 19482377
• Cook AM, Peppard A, Magnuson B. Nutrition considerations in traumatic brain injury. Nutr Clin Pract. 2008 Dec-2009 Jan;23(6):608-20. doi: 10.1177/0884533608326060. PMID 19033220

Идентификаторы

NCT: NCT05589064 · 101616

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗