Broccoli EffecT on glycated haemoglobin (HbA1c) - BETA study
Research type
Research Study
Full title
Broccoli EffecT on glycated haemoglobin (HbA1c) - BETA study A randomised double-blinded controlled trial
IRAS ID
281010
Contact name
Paul Kroon
Contact email
Sponsor organisation
Quadram Institute Biosceince
Duration of Study in the UK
2 years, 4 months, 28 days
Research summary
We propose to undertake a study in people who are aged 18 and over who have prediabetes (confirmed through screening), to determine whether broccoli soups affect glucose metabolism, compared to a similar soup containing no broccoli. We will assess blood samples for energy and glucose metabolism measurements. We will also quantify the metabolites in urine through analytical analysis and determine whether gene expression is altered by the soups.
We seek approval to undertake a randomised, double-blind, placebo-controlled, two-arm crossover intervention study, in which participants will be randomised into one of two soup arms (broccoli or courgette) for intervention period 1. After a 12-week washout phase, participants will move onto the alternative soup for intervention period 2. They will eat both soups over the course of the study and required to eat 3-soups-a-week per 12-week period.
The trial will run in total over a 36-week period and will involve blood and urine collections to be used for the purpose of the research. We will ask the participant to complete lifestyle questionnaires regarding their physical activity and dietary pattern.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
21/NW/0075
Date of REC Opinion
8 Jul 2021
REC opinion
Further Information Favourable Opinion