Postprandial effects of genetic variation on carbohydrate digestio

Not Applicable

Completed

• Conditions: utritional 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

• Registration Number: ISRCTN17837384
• Lead Sponsor: niversity College London (UCL) (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-06
• Last Update Posted: 5 June 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 48

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 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 < 8% or >25% for men and < 20% or >35% for women
5. Body mass index (BMI) <18.5 or >25.5
6. Blood pressure < 90/60 or >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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measures as of 10/03/2014:<br>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.<br><br>Previous primary outcome measures:<br>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.