RISSCI-1 Blood Cholesterol Response Study
NCT03270527 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 109
Last updated 2021-10-25
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 for raising blood LDL-cholesterol, and reducing its intake has been the mainstay of dietary guidelines for the prevention of heart disease for over 30 years. However, there is very little evidence for a direct link between the intake of saturated fat and risk of dying from heart disease. One explanation for this, is that the link between saturated fat intake and heart disease is not a direct one, but relies heavily on the ability of saturated fat to raise blood LDL-cholesterol levels. This LDL cholesterol-raising effect of saturated fat is complex, and highly variable between individuals because of differences in the metabolism of dietary fat and cholesterol between people. The main aim of this study is to measure the amount of variation in blood LDL-cholesterol in healthy volunteers at the Universities of Surrey and Reading in response to lowering the amount of saturated fat in the diet to the level recommended by the government for the prevention of heart disease. This collaborative project between the Universities of Reading, Surrey and Imperial ('RISSCI-1' Blood Cholesterol Response Study') will permit identification of two subgroups of men who show either a high or low LDL-cholesterol response to a reduction in dietary saturated intake. These two groups of participants will be provided with an opportunity to participate in a similar follow-up study ('RISSCI-2') that will also take place at the University of Surrey and Reading. In this follow-up study, the participants will be asked to repeat a similar study protocol as for RISSCI-1, but undergo more detailed measurements to investigate the metabolic and genetic origins of how saturated fat is metabolised in the body and influences blood LDL-cholesterol (LDL-C).
Conditions
- Lipids
- Lipid Metabolism
- Healthy
Interventions
- OTHER
-
High SFA diet (Diet 1)
'Diet 1' will contain \~18% of its total energy as SFA .
- OTHER
-
Low SFA diet (Diet 2)
'Diet 2' will contain \~10% of its total energy as SFA. The SFA-replacement fats will be mixture of PUFA/MUFA.
Sponsors & Collaborators
-
University of Reading
collaborator OTHER -
Imperial College London
collaborator OTHER -
University of Surrey
lead OTHER
Principal Investigators
-
Bruce Griffin, PhD · University of Surrey
-
Julie Lovegrove, PhD · University of Reading
Study Design
- Allocation
- NA
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 35 Years
- Max Age
- 65 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-09-01
- Primary Completion
- 2019-07-31
- Completion
- 2019-07-31
Countries
- United Kingdom
Study Locations
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