Healthy Clinical Trial
— RISSCI-1Official title:
Reading Imperial Surrey Saturated Fat Cholesterol Intervention (RISSCI) Study. RISSCI-1 Blood Cholesterol Response Study
NCT number | NCT03270527 |
Other study ID # | RN0307A |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 1, 2017 |
Est. completion date | July 31, 2019 |
Verified date | October 2021 |
Source | University of Surrey |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 109 |
Est. completion date | July 31, 2019 |
Est. primary completion date | July 31, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 35 Years to 65 Years |
Eligibility | Inclusion Criteria: - BMI of 19-32 kg/m2 - Fasting serum total cholesterol < 7.5 mmol/l and triacylglycerol < 2.3 mmol/l Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Department of Nutritional Sciences, University of Surrey | Guildford | Surrey |
United Kingdom | Department of Food and Nutritional Sciences, University of Reading | Reading | Berkshire |
Lead Sponsor | Collaborator |
---|---|
University of Surrey | Imperial College London, University of Reading |
United Kingdom,
Vafeiadou K, Weech M, Altowaijri H, Todd S, Yaqoob P, Jackson KG, Lovegrove JA. Replacement of saturated with unsaturated fats had no impact on vascular function but beneficial effects on lipid biomarkers, E-selectin, and blood pressure: results from the randomized, controlled Dietary Intervention and VAScular function (DIVAS) study. Am J Clin Nutr. 2015 Jul;102(1):40-8. doi: 10.3945/ajcn.114.097089. Epub 2015 May 27. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Genotyping for apolipoprotein E to determine the impact of this genotype on changes in the primary and secondary outcome measurements in response to dietary fat intake | Baseline | ||
Primary | Changes in fasting total cholesterol (consisting of LDL-cholesterol and HDL) concentrations | Baseline, 4 weeks (after diet 1), 8 weeks (after diet 2) | ||
Secondary | Fasting triacylglycerol | Baseline, 4 weeks (after diet 1), 8 weeks (after diet 2) | ||
Secondary | HDL immune functions | Baseline, 4 weeks (after diet 1), 8 weeks (after diet 2) | ||
Secondary | HDL anti-inflammatory and anti-oxidant (PON-1) properties | Baseline, 4 weeks (after diet 1), 8 weeks (after diet 2) | ||
Secondary | HDL capacity to promote cholesterol efflux (ex-vivo) | Baseline, 4 weeks (after diet 1), 8 weeks (after diet 2) | ||
Secondary | Fasting insulin, glucose | Baseline, 4 weeks (after diet 1), 8 weeks (after diet 2) | ||
Secondary | Adhesion molecules, markers of vascular function | Baseline, 4 weeks (after diet 1), 8 weeks (after diet 2) | ||
Secondary | Inflammatory markers & adipokines | Baseline, 4 weeks (after diet 1), 8 weeks (after diet 2) | ||
Secondary | LDL-R gene expression | Baseline, 4 weeks (after diet 1), 8 weeks (after diet 2) | ||
Secondary | Other relevant genes involved in the absorption and metabolism of dietary fat | Polymorphic genes with potential influence on the serum LDL response to dietary saturated fat, e.g.: ATP-binding cassette proteins (cholesterol efflux proteins) ABCG5 (e.g. C1950G) ABCG8 (e.g. D19H, C1895T), functional polymorphisms in the farnesoid X receptor (FXR) and bile acid transporters (e.g. solute carrier organics anion 1B1). Fatty acid desaturases (FADS1 and FADS2). The patatin-like phospholipase domain-containing protein (PNPLA3) (e.g. rs738409 C/G), eNOS. Lipid/cholesterol homeostasis: serum apolipoprotein genes: APOE (e2,e3,e4 e.g. rs429358 and rs7412), APOA-I (e.g. -75G/A), APOA4 (e.g. 360-2), APOA5 (e.g. -113/T>:c), APOCIII, APOB (e.g. -516C/T). Lipase genes: (e.g. LPL, HL, MGLL). Lipoprotein receptor genes (e.g. pvu11 in the LDL receptor), lipid transfer proteins (e.g. CETP e.g Taq1B, MTP), and other polymorphic genes related to the absorption and metabolism of dietary fat and regulation of lipid/cholesterol homeostasis. | Baseline | |
Secondary | Metabolomic analysis for the determination of the low molecular weight metabolite profiles in the biological fluids | Analyses conducted by Imperial College London | Baseline, 4 weeks (after diet 1), 8 weeks (after diet 2) | |
Secondary | Changes in faecal bacterial population | Baseline, 4 weeks (after diet 1), 8 weeks (after diet 2) | ||
Secondary | Weight | BMI will also be calculated (kg/ height in m^2) | Baseline, 4 weeks (after diet 1), 8 weeks (after diet 2) | |
Secondary | Fat mass | Baseline, 4 weeks (after diet 1), 8 weeks (after diet 2) | ||
Secondary | Fat free mass | Baseline, 4 weeks (after diet 1), 8 weeks (after diet 2) | ||
Secondary | Waist circumference | Baseline, 4 weeks (after diet 1), 8 weeks (after diet 2) | ||
Secondary | Hip circumference | Baseline, 4 weeks (after diet 1), 8 weeks (after diet 2) | ||
Secondary | Blood pressure | Baseline, 4 weeks (after diet 1), 8 weeks (after diet 2) | ||
Secondary | Fasting vascular stiffness | Measured via pulse wave assessment using the Mobil-O-graph device. | baseline, 4 weeks (after diet 1), 8 weeks (after diet 2) |
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