None listed
Conditions
Brief summary
The modern diet is nutrient poor and high in processed sugary food promoting inflammation and metabolic dysregulation. Nutrition can play a crucial role in the modulation of inflammatory processes and may be a useful pain management tool. The aim of this research is to determine if a well-formulated ketogenic diet (WFKD) will alter reported pain in patients with chronic pain. The primary hypothesis is that a WFKD will result in a reduction in reported pain for patients with chronic pain. This study will implement a run-in period of 3 weeks where all participants will undertake a whole-food diet (WFD) that focuses on improving diet quality based on the NOVA classifications of unprocessed or minimally processed foods/ingredients (removal of NOVA category 4 foods from diet). Participants will be randomised from the start of week 4 into either a WFKD (intervention) or to continue the WFD. The WFKD will adjust carbohydrate level for the individual participant to achieve average blood ketone levels of between 0.5 and 3.0 mmol/L. The intervention will run for 9 weeks (total trial intervention 12 weeks). Participants will meet with the study researcher fortnightly via telehealth for education and monitoring. Participants will be followed up 12 weeks after completing the intervention.
Interventions
This study will implement a run-in period of 3 weeks where all participants will undertake a whole-food diet (WFD) that focuses on improving diet quality, based on the NOVA classifications of unprocessed or minimally processed foods/ingredients (removal of NOVA category 4 foods from diet).
Participants will be supplied with informational handouts, education and links to online sites that provide recipes by the researcher at the week 0 initial contact. The material and online links have been de
This study will implement a run-in period of 3 weeks where all participants will undertake a whole-food diet (WFD) that focuses on improving diet quality, based on the NOVA classifications of unprocessed or minimally processed foods/ingredients (removal of NOVA category 4 foods from diet). Participants will be supplied with informational handouts, education and links to online sites that provide recipes by the researcher at the week 0 initial contact. The material and online links have been developed specifically for the project from information provided from https://world.openfoodfacts.org/nova (the NOVA app will not be used as it does not apply to Australian products and is not in English). They will not be supplied with food but will be free to choose foods they prefer as long as they are minimally processed. They will not be required to monitor calories and can eat to satiety. They will commence the use of a daily online diary to record pain levels as well as self-evaluate their compliance to the diet (both as VAS scales). They will have phone and email access to the researchers for questions. Participants will be randomised from the start of week 4 into either a well-formulated ketogenic diet WFKD (the intervention) or to continue with the WFD. The participants in the intervention WFKD group will receive education, written materials and online resources at the Week 3 contact with the researcher which aim to restrict the dietary carbohydrate intake to between 30-50 grams per day. This is material specifically developed for the study, but also includes publicly accessible links such as www.dietdoctor.com. The group will also measure blood ketone levels via finger prick test daily for the first week to provide objective feedback as to whether they are in the target ketosis range (0.5 - 3.0 mmol/L) and will titrate their carbohydrate intake up or down based on this measure. They will continue to measure ketones at least 3 times per week throughout the intervention period (recorded in the daily diary). They will not be provided with food, but will be able to choose from a range of recipes that suit their preferences. To ensure nutrient adequacy, a nutrient checklist has been developed by the researcher in conjunction with a dietitian to provide a list of the top 10 low-carbohydrate foods (per serving size) for each vitamin and mineral. The participant will aim to include foods from each of the different categories each week. They will continue to record their daily pain, any adverse symptoms and adherence to the diet in the online diary. The WFD group will also measure blood ketones weekly, record their daily pain, any adverse symptoms and adherence to the diet in the online diary. Both groups will have fortnightly telehealth reviews during the intervention period (weeks 4-12) with the researcher which will allow for further education or assistance if required. Both groups will also complete an online 24 hour food recall (ASA24) at pre-screening, week 3,6,8,10 (on random days), at completion (week 13) and at follow-up (week 24). This will quantify changes in macronutrient and micronutrient intake.
Sponsors
Assoc Professor Kieron Rooney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• 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.
Exclusion criteria
• 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.
Outcome results
None listed