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 sites27 target enrollmentSeptember 22, 2020

Overview

No summary available.

Registry

who.int

Start Date

September 22, 2020

End Date

June 2, 2021

Last Updated

4 years ago

Study Type

Interventional

Sex

All

Sponsor

Assoc Professor Kieron Rooney

•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.

•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