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This study looks at the effect of broccoli soup on blood levels of glycated haemoglobin (HbA1c), compared with courgette soup. People aged 18 and older with prediabetes and a body mass index between 18.5 and 35 may take part. It is a study without an assigned phase and is currently active but not recruiting participants.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria:
* 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 Criteria:
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.