Hyperglycemia, Postprandial Clinical Trial
— DELVEOfficial title:
Postprandial Glycaemic Response in Different Ethnic Groups in East London and Its Association With Vitamin D Status
The goal of this study is to investigate the relationship between vitamin D status and a diabetes risk factor, postprandial glycaemic response in White, South Asian and Black African Caribbean populations in East London. The main question[s] it aims to answer are: - Are there differences in postprandial glycaemic response to a sugar water drink or orange juice between White, South Asian and Black African Caribbean people in East London? - Is there a relationship plasma 25(OH)D and the postprandial glycaemic response to a sugar water drink or orange juice consumption? - What are the knowledge and perceptions of vitamin D intake between White, South Asian and Black African Caribbean people in East London? - Is there a difference in dietary vitamin D intake between the three ethnic groups? Participants will make two visits to the lab, approximately 2.5 hours each. The order of the two drinks will be randomized via Excel Random function. For each visit, the blood sugar levels will be measured at fasting (0) and every 30 minutes up to 2 hours postprandially (5 times total) using a finger prick. At baseline only (visit 1), participants will fill out a knowledge and perception survey, provide a 4-day estimated food diary, provide a 7 ml blood sample via phlebotomy, and have their height, weight and body fat percentage measured.
Status | Recruiting |
Enrollment | 126 |
Est. completion date | August 2024 |
Est. primary completion date | August 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Age 18-65 years - Live in any East London Borough (Barking and Dagenham, Hackney, Havering, Newham Redbridge, Tower Hamlets or Waltham Forest) - Participants ethnicity is either White Caucasian, South Asian, or Black African-Caribbean Exclusion Criteria: - Diagnosis of diabetes - Diagnosis of a digestive system diseases - Diagnosis of a liver or kidney disease - Diagnosis of any other chronic diseases - Diagnosis of any blood clotting disorders - A body mass index (BMI) < 18.5 kg/m2 - Consume alcohol more than 14 units per week - Regular smoker (one or more cigarettes per day) - On special diet - Gluten sensitivity or celiac disease - Fasting blood glucose = 11 mmol/L |
Country | Name | City | State |
---|---|---|---|
United Kingdom | City, University of London | London |
Lead Sponsor | Collaborator |
---|---|
City, University of London | Barts & The London NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Participant body fat percentage | body fat percentage will be measured using a bioelectric impedance analyzer (BIA) a TANITA DC 360 P (Tanita, Amsterdam). Height will be measured using stadiometer and entered into the BIA in order to calculate the body fat percentage. Weight is also recorded during this process, but is not used as an outcome measure. | Measured fasted at baseline (0 min) only | |
Other | Participant body mass index (BMI) | BMI will be calculated from measured height in meters (using a stadiometer) and weight in kilograms (measured using a TANITA DC 360 P scale (Tanita, Amsterdam) using the formula: weight/(height*height) and reported in kg/m-2 | Measured fasted at baseline (0 min) only | |
Other | Plasma parathyroid hormone (PTH) | Venepuncture blood sample collected, analyzed and reported in pg/mL | Measured fasted at baseline (0 min) only | |
Other | Plasma calcium | Venepuncture blood sample collected, analyzed and reported in mmol/L | Measured fasted at baseline (0 min) only | |
Other | Total cholesterol | Venepuncture blood sample collected, analyzed and reported in mmol/L | Measured fasted at baseline (0 min) only | |
Other | High-density lipoprotein (HDL) | Venepuncture blood sample collected, analyzed and reported in mmol/L | Measured fasted at baseline (0 min) only | |
Other | Triglycerides (TG) | Venepuncture blood sample collected, analyzed and reported in mmol/L | Measured fasted at baseline (0 min) only | |
Other | C-reactive protein (CRP) | Venepuncture blood sample collected, analyzed and reported in mg/L | Measured fasted at baseline (0 min) only | |
Primary | Postprandial glycaemic response | Blood glucose concentrations measured using HemoCue glucose analyser (Angelholm, Sweden) at five time points for each beverage (one visit per beverage) | Measured at fasted baseline (0 min), +30, +60, +90 and +120 minutes for each beverage | |
Secondary | Plasma 25(OH)D | Indicator of vitamin D status | Measured fasted at baseline (0 min) only | |
Secondary | Dietary vitamin D intake | An estimated four-day food diary will be analyzed by using Nutritics software (Nutritics Ltd., Dublin). | Four consecutive days recorded between visits 1 and 2 (average 7 days) | |
Secondary | Knowledge and perception of vitamin D | Participants will complete a seven question questionnaire via Qualtrics survey platform adapted from Boland et al 2015 - A Survey of University Students' Vitamin D-Related Knowledge. All questions are weighted evenly, resulting in a maximum of 7 points. A higher score indicates a greater level of Vitamin D knowledge. | Measured fasted at baseline (0 min) only |
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