ACTRN12620000946910已完成未知
Effects of a well-formulated low-carbohydrate ketogenic diet (WFKD) on reported pain, blood biomarkers and quality of life in patients with chronic pain. A pilot randomised clinical trial.
Assoc Professor Kieron Rooney0 个研究点目标入组 27 人开始时间: 2020年9月22日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 27
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Body mass index >18.5.
- •18 years or over.
- •Chronic musculoskeletal pain experienced daily that has extended beyond 3 months.
- •Willing to be involved in dietary change and attend fortnightly videoconference/phone meetings.
- •Willing to monitor blood glucose and ketones via finger-prick (up to) daily.
- •Willing to be involved in dietary change that can include animal protein and fat.
- •Habitual diet is consistent with a standard western / moderate or high carbohydrate diet (defined for the study as 20% / 75g or more of total energy intake from carbohydrates per day based on 1-day recall AS24 as part of screening questionnaire). If the tested day does not meet this criterion, they will be asked to complete the diary again for another day. If both days do not meet the criteria, they will be excluded.
- •Willing to fill in a daily diary (5 mins per day).
- •VAS > 30/100mm at intake (based on average of current pain and previous week’s pain). If the tested day does not meet this criterion, they will be asked to complete the BPI again for another day. If both days do not meet the criteria, they will be excluded.
- •Use of other treatment therapies (such as physiotherapy, TENS, chiropractic, exercise program etc) must have been ongoing for 1 month prior to recruitment and subject is willing to continue therapy at the same level throughout the intervention.
- •Willing to maintain regularly prescribed pain medication or record changes in optional pain medication usage.
- •Access to a computer, laptop, tablet or smartphone along with internet access.
排除标准
- •Previous diagnosis of an eating disorder (including anorexia nervosa, bulimia or binge eating disorder).
- •Significant weight loss in last 3 months (<5% total body weight).
- •Previous bariatric surgery.
- •Unable to communicate in English.
- •Diagnosed psychiatric disorders (excluding anxiety or depression).
- •Cognitive impairment that limits ability to give informed consent or understand the study requirements.
- •Physical impairment that limits ability to meet the study requirements.
- •Pregnancy or lactation, or plan to become pregnant in the next 3 months.
- •Uncontrolled major medical conditions (including type 2 diabetes).
- •Type 1 diabetic or insulin dependent Type 2 diabetic
- •Prior history of hypoglycemia or insulinoma
- •Inherited disorders pertaining to oxidation of fatty acids
- •Metabolic or other disorders requiring medication (such as hypertension) unless they have consent of their GP to participate and agreement from the health care provider that they will be regularly monitored (fortnightly) by them to titrate medication if required.
- •Cancer diagnosis or cancer-related pain.
- •Pain presentations that include headache or migraine.
- •Pain presentations that pertain to the reproductive or gastrointestinal systems (such as irritable bowel syndrome or endometriosis). The presence of these pain syndromes as co-morbidities is not an exclusion, only if they are the presenting chronic pain described.
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