FLORA is a clinical trial investigating fibre supplements as a treatment for pre-diabetes. It has been shown that dietary fibre consumed in our every day diet can help maintain healthy blood glucose levels.
The FLORA Trial is trying to find out whether a unique powdered fibre mix helps maintain healthy blood sugar levels in people with pre-diabetes, where high blood sugar is a risk of diabetes.
The FLORA study is 24 weeks long and involves 3 in-person central clinical visits (these can be done on a weekend). The rest of the study will be conducted remotely, using a smartphone or computer. You will receive £75 for taking part.
People diagnosed with pre-diabetes in the past year
Myota
60
People
Personen
April 1, 2023
1.4.2023
1.4.2023
1.4.2023
After consenting to participate in the study, you will be randomly allocated to one of the trial arms. You will either take the FLORA fibre powdered mix or placebo, in addition to your regular diet.
The trial is single-blinded, which means that you as a participant you will not know whether you are taking the fibre mix or placebo until the end of the trial.
You will be asked to attend a central clinic on 3 occasions to give blood samples and measure your blood pressure. This will be at the start of the trial (week 1) and on weeks 16 and 24.
You will also be asked to complete an Oral Glucose Tolerance Test at the beginning of the trial and on week 16.
You will be asked to record online i) daily whether you have taken the fibre or placebo and ii) weekly any side-effects you may experience for weeks 1-4, and iii) your experiences of taking the powdered fibre/placebo on week 16 and 24
You will receive £75 for taking part plus an additional possible £20 per visit to cover travel expenses.
Taking part in this study may or may not help you personally with managing your pre-diabetes. But we hope this trial will help future people to receive the best evidence-based care.
People who meet the following criteria:
> Men and postmenopausal women aged 18-70
> Have an HbA1c test result which identifies you as being pre-diabetic in the last 12 months
> Have a body weight considered obese (Body Mass Index (BMI) of at least 25kg/m², but not be considered morbidly obese (BMI>45kg/m²)).
> Have access to a smartphone or a computer
> Willing to complete in-clinic blood tests and an online participant survey
