Broccoli Effect on Glycated Haemoglobin (HbA1c)

NCT05367024 | Active Not Recruiting

• 1 other identifier: QIB06-2020
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-diabetes

Keywords

Broccoli; Pre-diabetes; Glycated Haemoglobin (HbA1c); Glucose; Energy metabolism

Outcome Measures

Primary Outcomes (1)

• Change in glycated haemoglobin (HbA1c) after broccoli and courgette soup interventions

  Comparison of fasting blood for HbA1c at baseline and after soup interventions

  Week: 0, 12, 24 and 36.

Secondary Outcomes (8)

• Change in postprandial capillary glucose concentration

  3.5 hours

• Change in fasting plasma glucose (mmol/l) after broccoli and courgette soup interventions

  Week: 0 to12 and 24 to 36.

• Change in fasting plasma insulin (mmol/L) after broccoli and courgette soup interventions

  Week: 0 to12 and 24 to 36.

• Change in fasting serum fructosamine (µmol/L) after broccoli and courgette soup interventions

  Week: 0 to12 and 24 to 36.

• Change in fasting serum cholesterol (mmol/L) after broccoli and courgette soup interventions

  Week: 0 to12 and 24 to 36.

Study Arms (2)

Broccoli soup

EXPERIMENTAL

The soup will be made with a commercially available dried vegetable soup supplemented with broccoli powder.

Other: Broccoli soup

Courgette soup

SHAM COMPARATOR

The soup will be made with a commercially available dried vegetable soup supplemented with courgette powder.

Other: Courgette soup

Interventions

Broccoli soup OTHER

Participants will consume one broccoli soup three times a week for one 12-week intervention period as part of their normal diet.

Broccoli soup

Courgette soup OTHER

Participants will consume one courgette soup three times a week for one 12-week intervention period as part of their normal diet.

Courgette soup

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Quadram Institute Bioscience: lead
• Norfolk and Norwich University Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

Quadram Institute Bioscience

Norwich, NR4 7UQ, United Kingdom

Location

MeSH Terms

Conditions

Glucose Intolerance

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Paul A Kroon, PhD

  Quadram Institute Bioscience

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind masking
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Crossover Assignment

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: May 10, 2022
• Study Start: September 27, 2021
• Primary Completion: April 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 15, 2025

Record last verified: 2025-06

Locations

GB (1)