Investigating the feasibility and tolerability of a novel dietary supplement: The RePurpose Study

Not Applicable

Completed

• Conditions: Gastrointestinal symptoms; Depressive and anxiety symptoms; Mental Health - Depression; Mental Health - Anxiety; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12623000454673
• Lead Sponsor: Deakin University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-05-02
• Study Completion: 2023-12-20
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

•Community dwelling healthy adults aged between 18-65.
•Able to understand study materials and instructions in English.
•Live within the greater Geelong/Melbourne region.
•No major diseases (e.g., diabetes, cancer, bipolar disorder), health concerns (e.g., awaiting test results or medical consultation), medical conditions that may affect participant adherence to the trial intervention as determined by investigators (e.g., cognitive disorders, intellectual disability) or history of previous GI surgery, except cholecystectomy or haemorrhoidectomy.
•Willingness to commit to consuming the investigational products.
•Must have access to the internet and a computer/smartphone/tablet.
•Be willing to comply with all requirements and procedures of the study.
•Agree not to enrol in another interventional clinical research trial during part of the study.

Exclusion Criteria

• Pregnant or lactating women.
• Perceived or formally diagnosed food intolerance (e.g., lactose intolerance, gluten intolerance) or allergies (e.g., dairy or protein allergies).
• Following any therapeutic diets (e.g., calorie-restricted diet, low FODMAP).
• Co-existing eating disorder.
• Any major GI disorders such as inflammatory bowel disease (IBD), coeliac disease, or irritable bowel syndrome (IBS).
• Current use of prebiotic, probiotic or fibre supplements or use of these supplements in the past month.
• Antibiotic use within the past month.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility (composite primary outcome) will be evaluated by measuring the following:<br>- Intervention feasibility will be assessed by adherence to the study products, using a daily adherence diary and weekly online adherence questionnaire. <br>-Study feasibility will be evaluated by recruitment and attrition rate, using a study specific database. <br>[ Adherence to the study product will be measured post-baseline daily and at the end of week-1, 2, 3 and 4.<br>Recruitment and attrition rate will be evaluated at the end of the study (week-4).];Tolerability (composite primary outcome) will be measured by changes in gastrointestinal (GI) symptoms (assessed by simple numeric rating scale) and stool consistency (assessed by Bristol Stool Form Scale questionnaire).<br>[ Tolerability will be measured at baseline (every other day for 3 days) and post-baseline at week-1, 2, 3 and 4 (study end) over three time points (every other day for 3 days).]

Secondary Outcome Measures

Name	Time	Method
Psychological symptoms assessed by the short-form version of Depression Anxiety Stress Scale-21 questionnaires.[ Baseline and at the end of the study (week-4).];Quality of life assessed by the Assessment of Quality of Life (AQoL)-8D questionnaire. [ Baseline and at the end of the study (week-4).]; Perceived wellbeing assessed by the World Health Organisation Well-Being Index.[ Baseline and at the end of the study (week-4).];Gut microbiota composition and diversity assessed by 16s rRNA gene sequencing.[ Baseline and at the end of the study (week-4).]; Urine metabolomics assessed by high-throughput Nuclear Magnetic Resonance[ Baseline and at the end of the study (week-4).]