Clinical trial NCT05367024: Broccoli Effect on Glycated Haemoglobin (HbA1c)
Official title: Broccoli Effect on Glycated Haemoglobin (HbA1c) - BETA Study, A Randomised Double-blinded Crossover Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pre-diabetes
Keywords: Broccoli
Pre-diabetes
Glycated Haemoglobin (HbA1c)
Glucose
Energy metabolism
Lead sponsor: Quadram Institute Bioscience
Sponsor class: OTHER
Collaborators: name: Norfolk and Norwich University Hospitals NHS Foundation Trust
First posted: 2022-05-10
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover Assignment
Primary purpose: BASIC_SCIENCE

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in glycated haemoglobin (HbA1c) after broccoli and courgette soup interventions
timeFrame: Week: 0, 12, 24 and 36.
Secondary outcomes:
measure: Change in postprandial capillary glucose concentration
timeFrame: 3.5 hours
measure: Change in fasting plasma glucose (mmol/l) after broccoli and courgette soup interventions
timeFrame: Week: 0 to12 and 24 to 36.
measure: Change in fasting plasma insulin (mmol/L) after broccoli and courgette soup interventions
timeFrame: Week: 0 to12 and 24 to 36.
measure: Change in fasting serum fructosamine (µmol/L) after broccoli and courgette soup interventions
timeFrame: Week: 0 to12 and 24 to 36.
measure: Change in fasting serum cholesterol (mmol/L) after broccoli and courgette soup interventions
timeFrame: Week: 0 to12 and 24 to 36.
measure: Change in fasting serum triglycerides (mmol/L) after broccoli and courgette soup interventions
timeFrame: Week: 0 to12 and 24 to 36.
measure: Change in broccoli metabolites (glucosinolates, sulforaphane, and S-methyl cysteine sulfoxide) in 24 hour urine collection
timeFrame: Week: 0, 12, 24, and 36.
measure: Treatment effects on whole blood gene expression from RNAseq
timeFrame: up to 36 weeks.
Other outcomes:
Locations:
city: Norwich
country: United Kingdom
facility: Quadram Institute Bioscience
Study officials:
affiliation: Quadram Institute Bioscience
name: Paul A Kroon, PhD
role: PRINCIPAL_INVESTIGATOR
References: