None listed
Conditions
Brief summary
The purpose of this study is to investigate whether consuming protein supplements are a helpful dietary strategy for people with UC. Protein supplements are widely available at supermarkets, pharmacies and gyms and are recognised for many health benefits including increasing muscle mass and helping the body to repair and heal. We do not know how much protein people with UC need to consume to achieve these health benefits without affecting inflammation. It is hypothesised that protein supplementation will alter body composition, the gut microbiome and disease activity. This study involves consuming daily supplements which contain protein for 24-weeks.
Interventions
This is a double-blind, randomised, placebo-controlled supplementation study. The intervention and placebo will be provided to participants in the form of "supplement sachets" which will be developed in a commercial kitchen. The intervention sachet will contain 30g of whey protein isolate and 20g of full cream milk powder. Participants will consume three supplement sachets per day. Supplement sachets will be packaged in opaque black or white packaging to maintain blinding to the participants and
This is a double-blind, randomised, placebo-controlled supplementation study. The intervention and placebo will be provided to participants in the form of "supplement sachets" which will be developed in a commercial kitchen. The intervention sachet will contain 30g of whey protein isolate and 20g of full cream milk powder. Participants will consume three supplement sachets per day. Supplement sachets will be packaged in opaque black or white packaging to maintain blinding to the participants and study team. Only a research dietitian not involved in dietary education or data collection will be unblinded to which colour is allocated to the intervention and placebo. Participants will consume 2-3 supplement sachets per day for 24-weeks. Participants will receive a face-to-face 30-minute dietary education by a research dietitian at baseline to educate them on how they can incorporate the supplement sachets into their habitual diet. Participants will be educated on what foods from their usual diet they can replace with the supplement sachets to assist with maintaining an isocaloric intake. Participants will also be educated on eating to appetite. Education will be consistent across study arms to maintain consistency given the research dietitian will not know what supplement sachet participants are receiving. Participants will receive a supplement shaker cup and a supplementation guide as part of their dietary education. The supplementation guide will provide different ideas of how the sachets can be incorporated into different foods or fluids. Adherence will be assessed via self-reported questionnaire indicating number of non-adherent days and confirmed by participants returning their supplement packaging.
Sponsors
The Queen Elizabeth Hospital, Central Adelaide Local health Network
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Adults aged 18 years or older - Formal diagnosis of UC - Stable on therapy for defined periods: ---> 4 weeks if no therapies ---> 4 weeks for oral and/or topical Aminosalicylates (5-ASA’s) ---> 8 weeks for immunomodulatory therapy ---> greater than or equal to 8 weeks anti-TNF (tumour necrosing factor)/ Ustekinumab/small molecule therapy ---> greater than or equal to 12 weeks vedolizumab ---> greater than or equal to 4 weeks after cessation of corticosteroids (prednisalone or budesonide) ---> greater than or equal to 4 weeks of stable dosing of prednisalone (less than or equal to 20mg) if steroid refractory - Clinical disease activity score: Patient reported outcome (PRO2) score of less than or equal to 1 (where sub-score for rectal bleeding is equal to 0 and sub-score for stool frequency is equal to 1) - A faecal calprotectin level of less than or equal to 250µg/g. - Able to provide informed consent - Willing to consume animal protein-based supplement sachets
Exclusion criteria
- Aged < 18 years old - Pregnant or breastfeeding - Formal diagnosis of Crohn’s disease or Inflammatory Bowel Disease-Undetermined - Chronic liver or kidney disease - Enrolled in another clinical trial - Unable to provide informed consent - Cow’s milk protein allergy, soy allergy or lactose intolerance - Vegan or ovo-vegetarian (does not consume animal by-products) - Reliant on enteral and/or parenteral nutrition for provision of nutrition - Prior colonic surgery - Washout periods required for: ---> no protein supplementation in the past 2 weeks before trial commencement. ---> no antibiotic or corticosteroid use for any infection of other medical reason (except inclusion criteria above for corticosteroids) within the past 4 weeks prior to trial commencement ---> Diagnosis of COVID-19 infection within the past 4 weeks prior to trial commencement ---> No medications that alter bowel habit within the past 2 weeks of trial commencement (laxatives, opioids, anti-emetics, probiotics, anti-diarrhoeal)
Outcome results
None listed