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Active Not RecruitingNCT05367024

Broccoli Effect on Glycated Haemoglobin (HbA1c)

Broccoli Effect on Glycated Haemoglobin (HbA1c) - BETA Study, A Randomised Double-blinded Crossover Study

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
26 (actual)
Sponsor
Quadram Institute Bioscience · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Broccoli has shown to normalise elevated blood sugars when eaten over long period of time. Individuals with pre-diabetes have higher than normal blood sugar levels. In this study, investigators are trying to understand how broccoli, when eaten as a soup, affects blood sugar levels in individuals with pre-diabetes.

Detailed description

The BETA study is a 36-week randomized, double-blind, placebo-controlled, two-arm crossover intervention study conducted at the Quadram Institute Clinical Research Facility (QI CRF), Norwich, UK. Investigators are seeking adults with pre-diabetes, to determine whether broccoli soups affect glucose metabolism, compared to a similar soup containing courgette. There are a total of 9 clinical visits (1 screening visit, 4 short visits, and 4 oral glucose tolerance testing visits). Investigators will assess blood samples for glycated hemoglobin (HbA1c), fasting plasma glucose, insulin, fructosamine, cholesterol and triglycerides. Investigators will also quantify the metabolites in urine through analytical analysis and determine whether gene expression is altered by the soups through RNA sequencing. Participants will consume one of two soups (broccoli or courgette) for the first intervention period then after a twelve-week washout phase (soup holiday), participants will crossover and consume the other soup for the second intervention period. For each intervention period, soups will be consumed three times a week per twelve-week period. Investigators will ask the participant to complete lifestyle questionnaires regarding their physical activity and dietary pattern.

Conditions

Interventions

TypeNameDescription
OTHERBroccoli soupParticipants will consume one broccoli soup three times a week for one 12-week intervention period as part of their normal diet.
OTHERCourgette soupParticipants will consume one courgette soup three times a week for one 12-week intervention period as part of their normal diet.

Timeline

Start date
2021-09-27
Primary completion
2026-04-01
Completion
2026-12-01
First posted
2022-05-10
Last updated
2025-06-15

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT05367024. Inclusion in this directory is not an endorsement.