RISSCI-1 Blood Cholesterol Response Study

NCT03270527 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2021-10-25

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03270527 on ClinicalTrials.gov