Healthy Men Clinical Trial
— INTERFATOfficial title:
The Acute Effects of Interesterification of Commercially Used Fats on Postprandial Lipaemia and Satiety: a Randomised Controlled Trial. The INTER-FAT Study
Verified date | March 2017 |
Source | King's College London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to investigate whether there are differences in postprandial metabolic indices following interesterified fats used in commercial spreads versus the corresponding un-interesterified blend.
Status | Completed |
Enrollment | 12 |
Est. completion date | December 2015 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: 1. Age: 18-45 2. Male 3. Healthy (free of diagnosed diseases listed in exclusion criteria) 4. Able to understand the information sheet and willing to comply with study protocol 5. Able to give informed consent Exclusion criteria: 1. Medical history of myocardial infarction, angina, thrombosis, stroke, cancer, liver or bowel disease or diabetes 2. Body mass index < 20 kg/m2 or > 35 kg/m2 3. Plasma cholesterol =7.5 mmol/L 4. Plasma triacylglycerol > 3 mmol/L 5. Plasma glucose > 7 mmol/L 6. Blood pressure =160/100 mmHg 7. Current use of antihypertensive or lipid lowering medications 8. Alcohol intake exceeding a moderate intake (> 28 units per week) 9. Current cigarette smoker 10. = 20% 10-year risk of cardiovascular disease as calculated using risk calculator 11. Ingestion of paracetamol in the preceding 24 hrs to study days |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Diabetes and Nutritional Sciences Division, School of Medicine, Kings College London | London |
Lead Sponsor | Collaborator |
---|---|
King's College London |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Satiety (Postprandial visual analogue scales) | Postprandial visual analogue scales | Postprandial 4 hrs | |
Other | Gastric emptying (Postprandial paracetamol concentrations) | Postprandial paracetamol concentrations | Postprandial 4 hrs | |
Primary | Postprandial lipaemia (Postprandial plasma triacylglycerol concentrations) | Postprandial plasma triacylglycerol concentrations | Postprandial 4 hrs | |
Secondary | Glycemia (Postprandial plasma glucose and insulin concentrations) | Postprandial plasma glucose and insulin concentrations | Postprandial 4 hrs | |
Secondary | Gut hormones (Postprandial gut peptide YY and glucose-dependent insulinotropic polypeptide concentrations) | Postprandial gut peptide YY and glucose-dependent insulinotropic polypeptide concentrations | Postprandial 4 hrs |
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