Last updated: May 5, 2024
Sponsor: Quadram Institute Bioscience
Overall Status: Active - Enrolling
Phase
N/A
Condition
Diabetes Mellitus, Type 2
Diabetes And Hypertension
Diabetes Prevention
Treatment
Courgette soup
Broccoli soup
Clinical Study ID
NCT05367024
QIB06-2020
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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
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 suchas 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, orgluten) of the test soups.
- Have been diagnosed or have a history of blood or clotting disorders such as anaemiaor thrombosis.
- Have been treated for heart disease, cancer, or diabetes.
- Are immunocompromised due to medications or viral infection such humanimmunodeficiency virus (HIV).
- Have low or high blood pressure with hypertension medication (≤90/60, ≥160/100respectively would be classed as abnormal).
- Have any acute or chronic illnesses that affects the outcome of the study such as agastrointestinal disorder. This will be assessed on a case by case basis by QI medicaladvisor.
- Plan to become pregnant during the study duration, pregnant or breastfeeding.
- Frequently take medications that may interfere with sugar metabolism or absorptionsuch 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 orfollow a diet programme which requires fasting for multiple days.
- Are a registered blood donor and have donated a large quantity of blood within thelast 16 weeks. Registered blood donors should abstain from blood donations for theduration 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 anotherdietary study in the last 3 months.
- Are related to or living with any member of the study team or part of themanagement/supervisory structure of the Chief Investigator.
- Have symptoms of COVID-19, been asked to self-isolate, or have been diagnosed withCOVID-19 in the last 14 days.
Study Design
Total Participants: 35
Treatment Group(s): 2
Primary Treatment: Courgette soup
Phase:
Study Start date:
September 27, 2021
Estimated Completion Date:
December 31, 2025
Study Description
Connect with a study center
Quadram Institute Bioscience
Norwich, NR4 7UQ
United KingdomSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.