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临床试验/NCT04459104
NCT04459104已完成不适用

The Association Between Pain, Nutrition and Glycemic Response in Chronic Low Back Pain and Breast Cancer Survivors: a Cross-over Trial.

Vrije Universiteit Brussel4 个研究点 分布在 1 个国家目标入组 121 人开始时间: 2020年9月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
121
试验地点
4
主要终点
Glycemic response

研究概览

简要总结

The development of chronic pain is one of the most seen sequelae in the cancer survivor population. Literature reports the presence of pain in approximately 40% of 5-year survivors. Specifically, in breast cancer survivors, chronic pain is estimated to be present in at least 50% of this population. On the other hand, chronic low back pain is one of the leading causes of disability and decrease in quality of life. It has huge economical, psychological and social impacts on individuals, society and health institutions.

Unhealthy dietary behavior is associated with the occurrence, maintenance and management of chronic pain. Also, excessive calorie intake and diets rich in sugar, fat, sodium and caffeine were observed in patients having chronic pain. However, although nutritional factors are suggested as an associated lifestyle factor of chronic pain, limited attention is given to dietary and nutritional factors in relation to chronic pain.

One particular mechanism drawing attention in the link between nutrition and pain are blood glucose levels and the glycemic response. Animal research shows the potential for reduced blood glucose to influence several pathways involved in chronic pain, including decreased oxidative stress, and reduced neuronal excitability. Given the link between blood glucose levels, as well as the evidence for the importance of interpersonal variability in the glycemic response, this glycemic response can also be of interest for chronic pain research. Finding a possible link between both the glycemic response and pain-related outcomes, could give direction to further research focussing on implementing (personalized) nutritional/dietary advise to maintain healthy blood glucose levels in people suffering from chronic pain.

Therefore, this study will provide the first step in this promising line of research, by being the first to look for differences in glycemic response between breast cancer survivors having chronic pain and healthy pain-free controls, and between chronic low back pain patients and healthy pain-free controls.

Secondly, this study will also investigate possible associations between glycemic response, pain-related outcomes, nutrition related outcomes, physical activity, and body composition for breast cancer survivors and chronic low back pain patients separately in comparison with healthy pain-free controls.

详细描述

Study Design:

This study will be carried out as an experimental, cross-over study, including two pain populations, one control group and two assessment sessions.

At the first session, firstly, all participants will undergo an assessment including pain-related outcomes, nutrition-related outcomes, and measures of physical activity, quality of life, body composition, and fasting blood glucose. Secondly, participants will be given a test beverage (with a high or low glycemic index, randomly decided), after which blood glucose levels will be assessed several times during the next 120 minutes.

At the second session, two days later (washout period), only fasting blood glucose levels will be tested again, after which the study participants will be given the other test beverage, after which blood glucose levels will be monitored once more for 120 minutes. Other outcome measures will not be re-assessed after exposure to the beverages, as we do not expect a direct influence of these test beverages on the outcome variables.

Results will be analysed and published separately for chronic low back pain patients and breast cancer survivors.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Glycemic response

时间窗: at the 2nd day

Blood glucose levels will be measured using OneTouch Verio (LifeScan Europe, Johnson \& Johnson, Switzerland). Blood glucose levels will be collected at 15, 30, 45, 60, 90, and 120 minutes after consumption of the beverages.

次要结局

  • Body Height(at the 1st day)
  • Central Sensitization Inventory(at the 1st day)
  • Douleur Neuropathique 4 Questionnaire(at the 1st day)
  • Pressure Pain Threshold(at the 1st day)
  • Electrical Temporal Summation(at the 1st day)
  • Brief Pain Inventory(at the 1st day)
  • Electrical Detection Threshold(at the 1st day)
  • Mediterranean Diet Score(at the 1st day)
  • Body muscle mass(at the 1st day)
  • Body Mass Index(at the 1st day)
  • Electrical PainThreshold(at the 1st day)
  • Electrical Offset Analgesia(at the 1st day)
  • Short Form- 36 Quality of Life(at the 1st day)
  • Body Weight(at the 1st day)
  • Body water(at the 1st day)
  • Healthy Eating Index(at the 1 st day)
  • 3 day dietary dairy(at the 1st day)
  • International Physical Activity Questionnaire(at the 1st day)
  • Body fat mass(at the 1st day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Malfliet Anneleen

Principal Investigator

Vrije Universiteit Brussel

研究点 (4)

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