Status:
ACTIVE_NOT_RECRUITING
Broccoli Effect on Glycated Haemoglobin (HbA1c)
Lead Sponsor:
Quadram Institute Bioscience
Collaborating Sponsors:
Norfolk and Norwich University Hospitals NHS Foundation Trust
Conditions:
Pre-diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 tr...
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. Inve...
Eligibility Criteria
Inclusion
- Individuals with prediabetes (confirmed through screening)
- Aged 18 and older.
- Body Mass Index (BMI) between 18.5 - 35 kg/m2.
- Living within 40 miles from the Norwich Research Park.
Exclusion
- The participant will not be able to take part if they('re):
- Screening test results indicate they are not suitable to take part in this study such as HbA1c level at screening visit of \< 42 mmol/mol (healthy) and \> 47 mmol/mol (diabetes) and BMI at screening visit \< 18.5 kg/m2 (underweight) and \> 35 kg/m2 (extremely obese).
- Have a known allergy to any of the components (broccoli, courgette, milk, lactose, or gluten) of the test soups.
- Have been diagnosed or have a history of blood or clotting disorders such as anaemia or thrombosis.
- Have been treated for heart disease, cancer, or diabetes.
- Are immunocompromised due to medications or viral infection such human immunodeficiency virus (HIV).
- Have low or high blood pressure with hypertension medication (≤90/60, ≥160/100 respectively would be classed as abnormal).
- Have any acute or chronic illnesses that affects the outcome of the study such as a gastrointestinal disorder. This will be assessed on a case by case basis by QI medical advisor.
- Plan to become pregnant during the study duration, pregnant or breastfeeding.
- Frequently take medications that may interfere with sugar metabolism or absorption such as laxatives, steroids, dietary supplements, or anti-inflammatory medications. This will be assessed on a case by case basis by QI medical advisor.
- Drink more than 14 alcohol units/week.
- Smoke socially or on occasion more than 12.5 grams or 20 cigarettes/week
- Vegan or any dietary restrictions that prevent the consumption of study soups or follow a diet programme which requires fasting for multiple days.
- Are a registered blood donor and have donated a large quantity of blood within the last 16 weeks. Registered blood donors should abstain from blood donations for the duration of the study.
- Are unable to give written or verbal informed consent
- Unable to provide GP contact details.
- Are participating in another dietary intervention study nor given blood in another dietary study in the last 3 months.
- Are related to or living with any member of the study team or part of the management/supervisory structure of the Chief Investigator.
- Have symptoms of COVID-19, been asked to self-isolate, or have been diagnosed with COVID-19 in the last 14 days.
Key Trial Info
Start Date :
September 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2026
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT05367024
Start Date
September 27 2021
End Date
December 1 2026
Last Update
June 15 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Quadram Institute Bioscience
Norwich, United Kingdom, NR4 7UQ