Status:
COMPLETED
RISSCI-1 Blood Cholesterol Response Study
Lead Sponsor:
University of Surrey
Collaborating Sponsors:
University of Reading
Imperial College London
Conditions:
Lipids
Lipid Metabolism
Eligibility:
MALE
35-65 years
Phase:
NA
Brief Summary
Raised blood cholesterol (also referred to as blood LDL-cholesterol) is a major risk factor for developing heart disease. Dietary saturated fat is recognised as the main dietary component responsible ...
Detailed Description
The LDL cholesterol-raising effect of saturated fatty acids (SFA) is complex, and highly variable between individuals because of differences in the metabolism of dietary fat and blood cholesterol betw...
Eligibility Criteria
Inclusion
- BMI of 19-32 kg/m2
- Fasting serum total cholesterol \< 7.5 mmol/l and triacylglycerol \< 2.3 mmol/l
Exclusion
- Smokers
- Medical history of myocardial ischemia or stroke in the past 12 months;
- Diabetes (defined as fasting glucose \> 7.0 mmol/l) or other endocrine disorders; kidney, liver, pancreas or gastrointestinal disorders
- Hypertension (blood pressure \> 140/90 mmHg),
- Cancer
- Medication for hyperlipidaemia (e.g. statins), hypertension, inflammation or prescribed antibiotics within the last three months
- Drinking in excess of 14 units of alcohol per week,
- Anaemia (\<130 g/L haemoglobin), or planning on a weight-reducing regime
- Taking any dietary supplements known to influence lipids/gut microbiota (eg. plant stanols, fish oil, phytochemicals, natural laxatives, probiotics and prebiotics)
- Any other unusual medical history or diet and lifestyle habits or practices that would preclude volunteers from participating in a dietary intervention and metabolic study.
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2019
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT03270527
Start Date
September 1 2017
End Date
July 31 2019
Last Update
October 25 2021
Active Locations (2)
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1
Department of Food and Nutritional Sciences, University of Reading
Reading, Berkshire, United Kingdom, RG6 6AP
2
Department of Nutritional Sciences, University of Surrey
Guildford, Surrey, United Kingdom, GU2 7WG