None listed
Conditions
Brief summary
This study aims to explore the effects of a 4-week dietary fibre powder developed by ECU, known as urgut, (Provisional Patent 2023902137) as a dietary fibre powder in well-trained endurance athletes and community members with gastrointestinal (GI) disturbance. Outcomes of interest will be gut symptoms, gut transit time, gut microbiota and biomarkers of gut health in both stool and blood, as well as self-reported mental health, and quality of life.
Interventions
Baseline observation (week 0 )
At the first clinic visit, blood sample will be collected from participants by a certified phlebotomist, and their body weight and percentage of lean and fat mass will be obtained using the BOD POD® (Cosmed, Rome, Italy). Participants will also complete the questionnaires about GI symptoms, mental health and quality of life. To assess gut transit time, at the first clinic visit, participants will be asked to consume two blue muffins (provided) and the time will be
Baseline observation (week 0 ) At the first clinic visit, blood sample will be collected from participants by a certified phlebotomist, and their body weight and percentage of lean and fat mass will be obtained using the BOD POD® (Cosmed, Rome, Italy). Participants will also complete the questionnaires about GI symptoms, mental health and quality of life. To assess gut transit time, at the first clinic visit, participants will be asked to consume two blue muffins (provided) and the time will be recorded. They will then be asked to report the time of the bowel movement when they first note a blue-green colour in their stool. Participants will be educated to record their 3-day food diary via a free smart-phone application, Research Food Diary (Xyris, QLD, Australia). A stool kit and an instruction sheet will be provided to participants to collect their stool sample on the last day of the dietary record period. Intervention (week 1 - week4) After baseline (T1) assessments, participants will be provided a resealable bag of the fibre powder for the 4-week intervention phase along with recommended consumption methods, and scheduled consumption dosage. With regard to the fibre intervention, the 4-week period is scheduled as a 10-day ramping up from 5 g/d to 40 g/d, and full-serve for 11 days at 40 g/d, followed by a 7-day maintenance serve at 20 g/d. Participants will be educated to divide the daily serve between breakfast and dinner, consuming as a beverage or within recommended recipes that avoid heating over 140 degrees. Participants will be required to maintain their habitual diet throughout the study and complete weekly GI symptom questionnaires before attending a final clinic visit for the T2 assessments. At the end of the intervention, participants will be asked to attend the final clinic visits to repeat the measurements assessed at the first visits. Participants will be asked to return any unused portion of the fibre powder provided, which will be weighed to calculate the total quantity of consumption. The fibre powder The dietary fibre powder is a mixture of dietary fibres, developed by researchers at Edith Cowan University, which also assisted study participants to meet Australian Dietary Guideline recommendations for fibre (Yan, 2023). This study was conducted at ECU (School of Medical and Health Science).
Sponsors
Edith Cowan University
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Inclusion criteria Both groups of Community members and athletes: 1) Aged 18 - 65 years old; 2) Available to attend local clinic visits at ECU Joondalup and willing to consume the intervention dietary formula; 3) Have self-reported GI symptoms (mild to severe) within at least 3 months prior to the commencement of the study. Community members: 1) Healthy adults with < 3 hours per week of moderate and high intensity physical activity (e.g. jogging, running, fitness classes in the gym, Pilates) Athletes: 1). Be either a long-distance runner and/or triathlete and currently following a periodised training plan which, at peak, involved performing greater than 10 hours of training each week and including greater than 90 minutes endurance training each week.
Exclusion criteria
1) Current smoker 2) Pregnant or planning to become pregnant; 3) Breastfeeding; 4) Have a known diagnosis of other gastrointestinal illness (e.g. Inflammatory Bowel Disease, bowel resection, coeliac disease); 5) Previous abdominal or gastrointestinal surgeries that affect GI function and absorption; 6) Have been taking antibiotics in the past four weeks 7) Have been taking other medication to modify or treat chronic GI illness, or mental health conditions; 8) Renal or hepatic diseases, and/or other major medical illness, condition or habit that may interfere with completion of the study. 9) Have been under severe mental health conditions, which is indicated by the DASS-21, mental health questionnaire.
Outcome results
None listed