Nutritional health relating to carbohydrate digestion and metabolism, scope includes but the study is not designed to test association to type 2 diabetes Nutritional, Metabolic, Endocrine
Conditions
Interventions
Current interventions as of 22/09/2014:
As part of the screening procedures, participants will make a saliva sample by spitting into a collection pot. This is pain free and will be demonstrated to the
this will be done following standard venepuncture procedures and performed by highly trained professionals.
Participants will attend two study days where they will be asked to consume the test meals
this will be done following standard venepuncture procedures and performed by highly trained professionals.
During the study day a fixed needle (cannula) will be inserted into the forearm of the part
Sponsors
University College London (UCL) (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 10/03/2014: 1. Healthy, non-smoking, men and women aged between 18-40 years old 2. British participants who were born in the UK and who have four grandparents that were also born in the UK Previous inclusion criteria: Healthy, non-smoking, men and women, aged 18-40 years, of British ethnicity
Exclusion criteria
Exclusion criteria: Exclusion criteria identified during visit 1 using questionnaire: 1. The subject is an employee of Unilever 2. Medical history of myocardial infarction, angina, thrombosis, stroke, cancer or diabetes 3. Medical history of eating disorders such as anorexia nervosa, bulimia, binge eating disorder 4. Medical history of digestive dysfunction, or intestinal disease such as IBS and Crohn?s disease 5. Medical history of pancreatitis (Acute, Chronic or Hereditary) and exocrine pancreatic insufficiency 6. Alcohol intake exceeding a moderate intake (>28 units per week) 7. Needle phobic, fear of blood and blood clotting disorders such as haemophilia 8. Pregnant, breast-feeding and post-menopausal women Exclusion criteria identified after visit 2, using genetic and health screening methods: 1. Fasting plasma glucose > 6.0 mmol /L 2. Fasting plasma insulin > 60 pmol/L 3. Fasting plasma cholesterol > 7.8 mmol /L 4. Body fat percentage 25% for men and 35% for women 5. Body mass index (BMI) 25.5 6. Blood pressure 120/80 7. Abnormal liver function The following will be recorded but are not considered grounds for exclusion, as there is no evidence that this will cause adverse response or distress to the subjects, but it may be of interest. 1. Diagnosed lactose intolerance 2. Confirmed gluten sensitivity, including coeliac disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 10/03/2014: The primary outcome measures will be the postprandial changes in indices of glucose metabolism and insulin secretion. Blood samples will be collected for the analysis of plasma glucose and plasma insulin. Previous primary outcome measures: Primary outcome measures are plasma glucose and plasma insulin concentrations, which are to be measured at t = baseline (blood samples taken before the participant consumes the test carbohydrate.-15, -5), 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 mins. Plasma glucose is used to determine postprandial glycaemic responses and plasma insulin is used to determine postprandial insulinaemic responses. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 10/03/2014: Secondary outcome measures will be to use blood samples collected in the postprandial study to analyse the effect of gut hormone response to the ingestion and digestion of different CHOs. This will be done by analysing concentrations of gut hormones including incretin, glucose-dependent insulinotropic polypeptide (GIP), glucagon-like polypeptide-1 (GLP-1) peptide YY (PYY) and cholecystokinin (CCK). Blood fractions for C-peptide analysis will also be collected, as a marker of the rate of insulin synthesis, to be used in addition to insulin concentrations to understand the postprandial insulinaemic response. Finally, the DNA samples collected in this study will be used to further investigate genetic variation in the genes of CDEs and to estimate the frequency of the polymorphic genetic loci in CDEs within the healthy UK population. This data will then be used in population-based genetic analysis to draw conclusions about human evolution and adaptation to dietary changes. Previous secondary outcome measures: Further genetic analysis of the DNA samples collected in this study will take place after the conclusion of the trial so that participants do not lose interest. The informed consent form signed prior to swab collection ensures that the volunteers know that their DNA will be analysed using population genetic techniques. Data generated from genetic analysis of DNA samples collected as part of this trial will be analysed to make estimates of the frequency of variant alleles in CDEs within the healthy UK population. Doing this in conjunction with the latter stages of this trail may identify new genetic variants that affect the digestive health of the UK population. These data will also be incorporated into genotype data collected bioinformatically to inform on the global distribution of the studied genetic variants. Secondary outcome measures of blood-borne molecules include: 1. C-peptide concentrations measured a | — |
Countries
United Kingdom
Outcome results
None listed