None listed
Conditions
Brief summary
The aim of this project is to test the effectiveness of a seaweed dietary fibre extract on gut and metabolic health and, consequential effects on inflammatory related Palmoplantar / psoriatic Keratoderma symptoms. This study will follow the initial Bio-Belly Study 1, where we have already found significant outcomes in an overweight population. Improvements were seen in plasma cholesterol, inflammation and insulin, as well as a case study, anecdotal improvement to a psoriatic skin disorder. Therefore, we aim to demonstrate repeated efficacy of the seaweed extract in an independent sample population, and to increase the power by restricting it to overweight participants only, and not obese, as there was a larger effect size in the overweight population. In addition, we would like to recruit to test the anecdotal effect of improvement to psoriatic skin disorders found in the initial trial. We propose to undertake a randomised placebo controlled crossover trial, with two six week treatment arms. Therefore the trial in its entirety will last 12 weeks.
Interventions
This is a phase 2 clinical trial building upon Biobelly, the phase 1 pilot trial (ACTRN 12615001057572). This is the second human study for the intervention of soluble dietary fibre from seaweed. Participants will be recruited and randomly assigned in a cross over design to 2g or placebo controlled group for soluble extract from seaweed . This is to be ingested daily for 6 weeks and blood and faecel samples will be tested before and after the intervention. Then participants will be crossed to t
This is a phase 2 clinical trial building upon Biobelly, the phase 1 pilot trial (ACTRN 12615001057572). This is the second human study for the intervention of soluble dietary fibre from seaweed. Participants will be recruited and randomly assigned in a cross over design to 2g or placebo controlled group for soluble extract from seaweed . This is to be ingested daily for 6 weeks and blood and faecel samples will be tested before and after the intervention. Then participants will be crossed to the other treatment arm for a further 6 week intervention, with blood and faecal samples tested again after the second 6 week intervention. Therefore each study participant will be giving blood and faecal samples at 3 time points 6 weeks apart. There is no washout period between the 2 interventions as this is unnecessary. Participants are provided with a calendar sheet to provide daily adherence. Participants will receive more than the requisite amounts of supplements, this will vary accross participants and any unused supplements will be returned at the end of each 6 week intervention period. The record of intake (calendar) and the left over supplements will be monitored as a measure of compliance.
Sponsors
University of Wollongong
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
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
People with an overweight BMI (25-<30) and/or people with a keratoderma or psoriatic skin condition
Exclusion criteria
People without an overweight BMI (<25 or >/= 30) or no keratoderma or psoriatic skin condition. People who have recently been treated with antibiotics (last month) or who are currently on antibiotics. People with very high blood pressure, very high glucose sensitivity, severe digestive conditions such as IBS and Chron's disease. People with coronary heart disease.
Outcome results
None listed