Status:
ENROLLING_BY_INVITATION
Glycaemic Responses to Carbohydrate-rich Meals (GlyCarb)
Lead Sponsor:
Quadram Institute Bioscience
Collaborating Sponsors:
Norfolk and Norwich University Hospitals NHS Foundation Trust
Conditions:
Glycaemia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Carbohydrate-rich foods such as potatoes, bread, rice, pasta, breakfast cereals, biscuits and other snacks are a major component of the human diet. The effect of different carbohydrate-rich foods on b...
Detailed Description
The overarching aim of this project is to investigate a wide range of carbohydrate rich test meals (from 'off the shelf' commercially available products, through to enriched, restructured and re-formu...
Eligibility Criteria
Inclusion
- Men and women ≥ 18 years of age
- Have access to/own a smartphone or tablet or computer and are willing to use this with apps needed for the study
- BMI between 18 and 30 kg/m2 (calculated from self-reported height and weight)
- Fasted HbA1C \< 42 mmol/mol (6.0%)
- Willing to consume study foods (study foods and ingredients are discussed during the study talk)
Exclusion
- Smokers of tobacco-based cigarettes or electronic cigarettes (or stopped smoking less than 6 months ago)
- Gastro-intestinal disease/disorders e.g., Crohn's disease/ulcerative colitis
- Other medical conditions that are judged to affect the study outcome or which may compromise the well-being of the participant e.g., active cancer, haemophilia. This will be assessed on a case-by-case basis.
- Type 1 diabetes or insulin-dependent or non-insulin-dependent type 2 diabetes
- Active infection with COVID-19, unless they are willing to postpone the screening until after the end of the self-isolation period (10 days from test or symptoms).
- Prescribed and non-prescribed medications that may affect the study outcome or which may compromise the well-being of the participant e.g., warfarin, proton-pump inhibitors. This will be assessed on a case by-case-basis.
- Dietary supplements that are judged to affect the study outcome unless the participant is willing to discontinue them for 4 weeks preceding the start of the study and for the duration of the study. This will be assessed on a case-by-case basis and includes protein supplements (shakes) or supplements that are not taken on a regular basis (on and off), particularly those containing ascorbic acid which may affect glucose readings.
- Any known allergy, intolerance, or sensitivity to any food products oradhesives (for CGM application).
- Those following a restrictive diet that may affect the study outcome (e.g., 5:2 diet) unless they are willing to suspend the diet for the duration of the study.
- Women who are, or have been pregnant, within the last 12 months or who are breast-feeding
- Parallel participation in another research project that involves dietary intervention.
- Any person related to or living with any member of the study team.
- Those who are part of the line manager/supervisory team of the Chief Investigator
- Lack of capacity to provide written informed consent.
- Clinical eligibility test results deemed by the CRF medical advisor to be indicative of a health problem which may compromise the well-being of the participant or which could affect the study outcome.
Key Trial Info
Start Date :
February 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT05317429
Start Date
February 14 2022
End Date
June 30 2028
Last Update
July 24 2025
Active Locations (1)
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1
Quadram Institute
Norwich, Norfolk, United Kingdom, NR4 7UQ