LipidsRISSCI-1NCT03270527
RISSCI-1 Blood Cholesterol Response Study
A study testing High SFA diet (Diet 1) and Low SFA diet (Diet 2) in people with Lipids and Lipid Metabolism, run by University of Surrey at 2 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Lipids, Lipid Metabolism, Healthy
- What is being tested?
- High SFA diet (Diet 1) and Low SFA diet (Diet 2)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Sep 2017to 31 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI of 19-32 kg/m2
- Fasting serum total cholesterol < 7.5 mmol/l and triacylglycerol < 2.3 mmol/l
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Department of Nutritional Sciences, University of Surrey
Guildford, Surrey, GU2 7WG
Department of Food and Nutritional Sciences, University of Reading
Reading, Berkshire, RG6 6AP
About this study
Official title: Reading Imperial Surrey Saturated Fat Cholesterol Intervention (RISSCI) Study. RISSCI-1 Blood Cholesterol Response Study
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).
Read the 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 between people. While these differences in metabolism make it difficult to study how dietary SFA influences LDL-cholesterol in large numbers of people, they can be measured in the laboratory and used as biological markers to distinguish between people who respond well from those who will respond less well to moderate-fat diets, which are lower in SFA.
The main aim of this study is to measure the amount of variation in blood LDL-cholesterol in healthy male volunteers in response to the replacement of SFA with unsaturated fats, and to select LDL-C responders from non-responders for a subsequent metabolic study ('RISSC-2'). Estimate of statistical power and sample size for 'RISSCI-1': A decrease of 0.16 mmol/L (SD 0.54) in our primary outcome of fasting plasma LDL-C between the high- and low-SFA diets, as observed in a previous randomly controlled trial, will require a sample size of 92 participants, at 80% power and 5% significance level. An estimated attrition rate of 15% will increase this sample size to 106 participants. To recruit this sample of participants, we anticipate having to screen 150 volunteers (75 at each site).
Specific objectives:
- Undertake a dietary intervention study to examine the effects of two, 4 week diets that differ in their composition of fatty acids. The first diet ('Diet 1') will contain ~18% of its total energy as saturated fatty acids (SFA), while the second diet ('Diet 2') will contain ~10% of its total energy as SFA. Blood, urine and stool samples taken at the beginning (week 0) and end of Diet 1 (week 4), and end of Diet 2 (week 8), will be analysed to measure blood LDL-cholesterol and other relevant blood, urine and faecal metabolites. The white blood cell buffy coat will also be isolated from the blood samples collected at the baseline visit to enable genotyping of relevant genes involved in the absorption and metabolism of dietary fat.
- To examine the data for evidence of associations between the changes in blood LDL- cholesterol, and the physical and biochemical characteristics of the participants as possible determinants of the variation in serum cholesterol response. This will include measurement of a common genetic polymorphism in APOLIPOPROTEIN E, as an established determinant of variation in blood cholesterol in response to dietary SFA.
- To identify two subgroups of individuals whose blood LDL-cholesterol either responds ('Responders') or show little or no response ('Non-responders') on changing from Diet 1 to Diet 2, for participation in the follow-up study ('RISSCI-2'), which will be conducted at the Universities of Surrey, Reading and Imperial College London. In this follow-up study, the participants will be asked to repeat a similar study protocol as for RISSCI-1, and undergo more detailed measurements to determine how saturated fat is metabolised in the body.
Hypothesis:
In accordance with the variation in blood LDL-cholesterol response, that many studies have reported previously following substitution of dietary saturated with unsaturated fats, the investigators hypothesise that consuming Diet 1 (a high saturated fat diet) for 4 weeks followed by diet 2 (a low saturated fat/high unsaturated fat diet) for a further 4 weeks, will: 1) produce a variable distribution of responses in LDL-cholesterol that will enable the study of associations between the participants' baseline characteristics as possible determinants of the observed variation in blood LDL-cholesterol response, and 2) identify two distinct subgroups of individuals who either respond or show little or no response in their blood LDL- cholesterol. These distinct groups will be defined by the top and bottom ~10% of change in the concentration of blood LDL-cholesterol.
- Conditions
- Lipids, Lipid Metabolism, Healthy
- Being tested
- High SFA diet (Diet 1), Low SFA diet (Diet 2)
- Keywords
- Dietary fat modification, Lipids, LDL cholesterol, Dietary fatty acids, Saturated fat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High SFA diet (Diet 1)Other
'Diet 1' will contain ~18% of its total energy as SFA .
Low SFA diet (Diet 2)Other
'Diet 2' will contain ~10% of its total energy as SFA. The SFA-replacement fats will be mixture of PUFA/MUFA.
| Study group | Role | What they receive |
|---|---|---|
| High SFA diet to low SFA diet | Experimental | Participants will undergo, sequentially, a high SFA diet (Diet 1) followed by a low SFA diet (Diet 2) for 4 weeks each. Study visits will occur before and after each dietary intervention period. To comply with current UK dietary recommendations, Diets 1 and 2 will both contain ~35% energy from total fat. These diets will be consumed within the homes of free-living participants, by the substitution of ~40g of habitual fat, with either SFA-rich or mono/poly-unsaturated fatty acid-rich (MUFA/PUFA) cooking oils, spreads and snack foods, while maintaining their habitual diet (consistent intake of protein and carbohydrates, including dietary fibre). This will be achieved using a dietary exchange model developed and peer-reviewed for a previous dietary intervention study ('DIVAS') at the University of Reading, U.K. Receives: Other: High SFA diet (Diet 1); Other: Low SFA diet (Diet 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in fasting total cholesterol (consisting of LDL-cholesterol and HDL) concentrations
Measured: Baseline, 4 weeks (after diet 1), 8 weeks (after diet 2)
Secondary outcomes (18)
Fasting triacylglycerol
Measured: Baseline, 4 weeks (after diet 1), 8 weeks (after diet 2)
HDL immune functions
Measured: Baseline, 4 weeks (after diet 1), 8 weeks (after diet 2)
HDL anti-inflammatory and anti-oxidant (PON-1) properties
Measured: Baseline, 4 weeks (after diet 1), 8 weeks (after diet 2)
HDL capacity to promote cholesterol efflux (ex-vivo)
Measured: Baseline, 4 weeks (after diet 1), 8 weeks (after diet 2)
Fasting insulin, glucose
Measured: Baseline, 4 weeks (after diet 1), 8 weeks (after diet 2)
Adhesion molecules, markers of vascular function
Measured: Baseline, 4 weeks (after diet 1), 8 weeks (after diet 2)
Inflammatory markers & adipokines
Measured: Baseline, 4 weeks (after diet 1), 8 weeks (after diet 2)
LDL-R gene expression
Measured: Baseline, 4 weeks (after diet 1), 8 weeks (after diet 2)
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 (ε2,ε3,ε4 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.
Measured: Baseline
Metabolomic analysis for the determination of the low molecular weight metabolite profiles in the biological fluids
Analyses conducted by Imperial College London
Measured: Baseline, 4 weeks (after diet 1), 8 weeks (after diet 2)
Changes in faecal bacterial population
Measured: Baseline, 4 weeks (after diet 1), 8 weeks (after diet 2)
Weight
BMI will also be calculated (kg/ height in m^2)
Measured: Baseline, 4 weeks (after diet 1), 8 weeks (after diet 2)
Fat mass
Measured: Baseline, 4 weeks (after diet 1), 8 weeks (after diet 2)
Fat free mass
Measured: Baseline, 4 weeks (after diet 1), 8 weeks (after diet 2)
Waist circumference
Measured: Baseline, 4 weeks (after diet 1), 8 weeks (after diet 2)
Hip circumference
Measured: Baseline, 4 weeks (after diet 1), 8 weeks (after diet 2)
Blood pressure
Measured: Baseline, 4 weeks (after diet 1), 8 weeks (after diet 2)
Fasting vascular stiffness
Measured via pulse wave assessment using the Mobil-O-graph device.
Measured: baseline, 4 weeks (after diet 1), 8 weeks (after diet 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start1 Sep 2017
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for LipidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Surrey
- Sponsor type
- University, hospital or other
- Collaborators
- University of Reading, Imperial College London
- Responsible party
- Principal investigator, Bruce A. Griffin, University of Surrey
- Investigators
- Bruce Griffin, PhD, Principal investigator, University of SurreyJulie Lovegrove, PhD, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03270527
- Sponsor's protocol ID
- RN0307A
- Acronym
- RISSCI-1
- Status last verified
- Oct 2021
- First submitted
- 10 Aug 2017
- Last updated
- 25 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26016869Koutsos A, Griffin BA, Antoni R, Ozen E, Sellem L, Wong G, Ayyad H, Fielding BA, Robertson MD, Swann J, Jackson KG, Lovegrove JA. Variation of LDL cholesterol in response to the replacement of saturated with unsaturated fatty acids: a nonrandomized, sequential dietary intervention; the Reading, Imperial, Surrey, Saturated fat Cholesterol Intervention ("RISSCI"-1) study. Am J Clin Nutr. 2024 Oct;120(4):854-863. doi: 10.1016/j.ajcnut.2024.07.032. Epub 2024 Aug 5.
PubMed 39111551Sellem L, Antoni R, Koutsos A, Ozen E, Wong G, Ayyad H, Weech M, Schulze MB, Wernitz A, Fielding BA, Robertson MD, Jackson KG, Griffin BA, Lovegrove JA. Impact of a food-based dietary fat exchange model for replacing dietary saturated with unsaturated fatty acids in healthy men on plasma phospholipids fatty acid profiles and dietary patterns. Eur J Nutr. 2022 Oct;61(7):3669-3684. doi: 10.1007/s00394-022-02910-2. Epub 2022 Jun 6.
PubMed 35668120
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reading Imperial Surrey Saturated Fat Cholesterol Intervention (RISSCI) Study. RISSCI-1 Blood Cholesterol Response Study
- ClinicalTrials.gov ID
- NCT03270527
- Acronym / sponsor ID
- RISSCI-1 / RN0307A
- Conditions
- Lipids, Lipid Metabolism, Healthy
- Keywords
- Dietary fat modification, Lipids, LDL cholesterol, Dietary fatty acids, Saturated fat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- University of SurreyUniversity, hospital or other
- Collaborators
- University of Reading, Imperial College London
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 1 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 between people. While these differences in metabolism make it difficult to study how dietary SFA influences LDL-cholesterol in large numbers of people, they can be measured in the laboratory and used as biological markers to distinguish between people who respond well from those who will respond less well to moderate-fat diets, which are lower in SFA.
The main aim of this study is to measure the amount of variation in blood LDL-cholesterol in healthy male volunteers in response to the replacement of SFA with unsaturated fats, and to select LDL-C responders from non-responders for a subsequent metabolic study ('RISSC-2'). Estimate of statistical power and sample size for 'RISSCI-1': A decrease of 0.16 mmol/L (SD 0.54) in our primary outcome of fasting plasma LDL-C between the high- and low-SFA diets, as observed in a previous randomly controlled trial, will require a sample size of 92 participants, at 80% power and 5% significance level. An estimated attrition rate of 15% will increase this sample size to 106 participants. To recruit this sample of participants, we anticipate having to screen 150 volunteers (75 at each site).
Specific objectives:
- Undertake a dietary intervention study to examine the effects of two, 4 week diets that differ in their composition of fatty acids. The first diet ('Diet 1') will contain ~18% of its total energy as saturated fatty acids (SFA), while the second diet ('Diet 2') will contain ~10% of its total energy as SFA. Blood, urine and stool samples taken at the beginning (week 0) and end of Diet 1 (week 4), and end of Diet 2 (week 8), will be analysed to measure blood LDL-cholesterol and other relevant blood, urine and faecal metabolites. The white blood cell buffy coat will also be isolated from the blood samples collected at the baseline visit to enable genotyping of relevant genes involved in the absorption and metabolism of dietary fat.
- To examine the data for evidence of associations between the changes in blood LDL- cholesterol, and the physical and biochemical characteristics of the participants as possible determinants of the variation in serum cholesterol response. This will include measurement of a common genetic polymorphism in APOLIPOPROTEIN E, as an established determinant of variation in blood cholesterol in response to dietary SFA.
- To identify two subgroups of individuals whose blood LDL-cholesterol either responds ('Responders') or show little or no response ('Non-responders') on changing from Diet 1 to Diet 2, for participation in the follow-up study ('RISSCI-2'), which will be conducted at the Universities of Surrey, Reading and Imperial College London. In this follow-up study, the participants will be asked to repeat a similar study protocol as for RISSCI-1, and undergo more detailed measurements to determine how saturated fat is metabolised in the body.
Hypothesis:
In accordance with the variation in blood LDL-cholesterol response, that many studies have reported previously following substitution of dietary saturated with unsaturated fats, the investigators hypothesise that consuming Diet 1 (a high saturated fat diet) for 4 weeks followed by diet 2 (a low saturated fat/high unsaturated fat diet) for a further 4 weeks, will: 1) produce a variable distribution of responses in LDL-cholesterol that will enable the study of associations between the participants' baseline characteristics as possible determinants of the observed variation in blood LDL-cholesterol response, and 2) identify two distinct subgroups of individuals who either respond or show little or no response in their blood LDL- cholesterol. These distinct groups will be defined by the top and bottom ~10% of change in the concentration of blood LDL-cholesterol.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High SFA diet to low SFA diet | Experimental | Other: High SFA diet (Diet 1), Other: Low SFA diet (Diet 2)Participants will undergo, sequentially, a high SFA diet (Diet 1) followed by a low SFA diet (Diet 2) for 4 weeks each. Study visits will occur before and after each dietary intervention period. To comply with current UK dietary recommendations, Diets 1 and 2 will both contain ~35% energy from total fat. These diets will be consumed within the homes of free-living participants, by the substitution of ~40g of habitual fat, with either SFA-rich or mono/poly-unsaturated fatty acid-rich (MUFA/PUFA) cooking oils, spreads and snack foods, while maintaining their habitual diet (consistent intake of protein and carbohydrates, including dietary fibre). This will be achieved using a dietary exchange model developed and peer-reviewed for a previous dietary intervention study ('DIVAS') at the University of Reading, U.K. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI of 19-32 kg/m2
- Fasting serum total cholesterol < 7.5 mmol/l and triacylglycerol < 2.3 mmol/l
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High SFA diet (Diet 1)'Diet 1' will contain ~18% of its total energy as SFA . | Other | High SFA diet to low SFA diet |
| 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. | Other | High SFA diet to low SFA diet |
Primary outcome
Changes in fasting total cholesterol (consisting of LDL-cholesterol and HDL) concentrations
Time frame: Baseline, 4 weeks (after diet 1), 8 weeks (after diet 2)
18 secondary outcomes
Fasting triacylglycerol
Time frame: Baseline, 4 weeks (after diet 1), 8 weeks (after diet 2)
HDL immune functions
Time frame: Baseline, 4 weeks (after diet 1), 8 weeks (after diet 2)
HDL anti-inflammatory and anti-oxidant (PON-1) properties
Time frame: Baseline, 4 weeks (after diet 1), 8 weeks (after diet 2)
HDL capacity to promote cholesterol efflux (ex-vivo)
Time frame: Baseline, 4 weeks (after diet 1), 8 weeks (after diet 2)
Fasting insulin, glucose
Time frame: Baseline, 4 weeks (after diet 1), 8 weeks (after diet 2)
Adhesion molecules, markers of vascular function
Time frame: Baseline, 4 weeks (after diet 1), 8 weeks (after diet 2)
Inflammatory markers & adipokines
Time frame: Baseline, 4 weeks (after diet 1), 8 weeks (after diet 2)
LDL-R gene expression
Time frame: Baseline, 4 weeks (after diet 1), 8 weeks (after diet 2)
Other relevant genes involved in the absorption and metabolism of dietary fat
Time frame: Baseline
Metabolomic analysis for the determination of the low molecular weight metabolite profiles in the biological fluids
Time frame: Baseline, 4 weeks (after diet 1), 8 weeks (after diet 2)
Changes in faecal bacterial population
Time frame: Baseline, 4 weeks (after diet 1), 8 weeks (after diet 2)
Weight
Time frame: Baseline, 4 weeks (after diet 1), 8 weeks (after diet 2)
Fat mass
Time frame: Baseline, 4 weeks (after diet 1), 8 weeks (after diet 2)
Fat free mass
Time frame: Baseline, 4 weeks (after diet 1), 8 weeks (after diet 2)
Waist circumference
Time frame: Baseline, 4 weeks (after diet 1), 8 weeks (after diet 2)
Hip circumference
Time frame: Baseline, 4 weeks (after diet 1), 8 weeks (after diet 2)
Blood pressure
Time frame: Baseline, 4 weeks (after diet 1), 8 weeks (after diet 2)
Fasting vascular stiffness
Time frame: baseline, 4 weeks (after diet 1), 8 weeks (after diet 2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
- Background: PubMed 26016869Vafeiadou 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.
- Derived from this study: PubMed 39111551Koutsos A, Griffin BA, Antoni R, Ozen E, Sellem L, Wong G, Ayyad H, Fielding BA, Robertson MD, Swann J, Jackson KG, Lovegrove JA. Variation of LDL cholesterol in response to the replacement of saturated with unsaturated fatty acids: a nonrandomized, sequential dietary intervention; the Reading, Imperial, Surrey, Saturated fat Cholesterol Intervention ("RISSCI"-1) study. Am J Clin Nutr. 2024 Oct;120(4):854-863. doi: 10.1016/j.ajcnut.2024.07.032. Epub 2024 Aug 5.
- Derived from this study: PubMed 35668120Sellem L, Antoni R, Koutsos A, Ozen E, Wong G, Ayyad H, Weech M, Schulze MB, Wernitz A, Fielding BA, Robertson MD, Jackson KG, Griffin BA, Lovegrove JA. Impact of a food-based dietary fat exchange model for replacing dietary saturated with unsaturated fatty acids in healthy men on plasma phospholipids fatty acid profiles and dietary patterns. Eur J Nutr. 2022 Oct;61(7):3669-3684. doi: 10.1007/s00394-022-02910-2. Epub 2022 Jun 6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce Griffin, PhD principal investigator
University of Surrey
Julie Lovegrove, PhD principal investigator
University of Reading
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High SFA diet (Diet 1) and Low SFA diet (Diet 2) in people with Lipids and Lipid Metabolism, run by University of Surrey at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in fasting total cholesterol (consisting of LDL-cholesterol and HDL) concentrations (time frame: Baseline, 4 weeks (after diet 1), 8 weeks (after diet 2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03270527, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2021.