- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01384032
Study Into Genetic Influence on Cholesterol Response to Dietary Fat (Satgene)
June 27, 2011 updated by: University of Reading
Apolipoprotein E Genotype as a Determinant of LDL-cholesterol Response to Dietary Fat Manipulation
Cardiovascular disease (CVD) is recognised as one of the main causes of death in the western world.
LDL- cholesterol ('bad' cholesterol) and other lipids (fats) are important CVD risk factors.
Apolipoprotein E (apoE) is an important transporter of fats in the blood.
ApoE comes in E2, E3 and E4 forms, depending on your genetic make up.
Approximately 60% of the UK population are E3/E3, 25% E4 carriers and 15% E2 carriers.
There is some evidence to suggest that an E4 genotype may put you at modestly higher risk of CVD.
Furthermore although very inconclusive previous studies have suggested that E4 individuals are slightly more sensitive to the LDL-cholesterol modifying effects of dietary fats (saturated fat, total fat, fish oil) showing slightly, greater reductions when low levels of these fat are consumed, and greater increases when high levels of these fat are consumed.
Therefore, the aims of the Satgene study is to examine the impact of modifications in dietary total fat and saturated fat intakes, alone and in combination with fish oil supplement on LDL-cholesterol and other blood lipids, in individuals with an E3 and E4 genotype.
The levels of total fat and saturated fat used in the current study are within the range observed in a typical UK population.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
88
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Reading, United Kingdom, RG6 6AP
- Department of Food and Nutritional Sciences, University of Reading
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
Men & women 35-70 years BMI 20-32 kg/m2 Haemoglobin (anaemia): 12.5-18.0g/l (men) and > 11.5-16g/l (women) Gamma GT (liver function) (< 80 IU/l), Triglyceride (between 1-4 mmol/l), Plasma total cholesterol (4.5-8 mmol/l) Glucose (World Health organisation recommend <7 mmol/L).
Exclusion Criteria:
- Females who are breast feeding, may be pregnant, or if child-bearing potential are not taking effective contraceptive precautions
- Likely to alter oral contraceptive or HRT usage during the course of the study
- Blood Pressure > 160/100 mm Hg (UK guidelines for stage 2 hypertension)
- Had suffered a myocardial infarction or stroke in the previous 12 months
- Hypertensive medication
- Diabetics type I and II
- Any volunteers on a weight reducing diet, or vegan/vegetarians as study requires consumption of dairy products and fish oils
- On high dose fish oil supplements (> 1g EPA + DHA per day)
- Elevated lipids requiring medication such as statins, fibrates, gall bladder problems or other abnormalities of fat metabolism
- Subjects not willing to make the necessary dietary changes during the study
- Subjects drinking excessive alcohol (UK recommendations/wk currently for men are, no more than 21 units of alcohol per week or more than four units in any one day. For women, no more than 14 units of alcohol per week or more than three units per day).
- Subjects who train at a high level, or attend more than 3 hours organised exercise classes per week
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Low fat diet
Subjects were asked to consume a low fat diet for 8 weeks.
Composition: 28% energy from fat, 8% energy from saturated fat, 55% energy from carbohydrate.
Subjects were provided with low fat spread, cooking oil and snacks and asked to consume these in place of normally eaten equivalent foods.
Subjects were asked to consume two extra portions of carbohydrate per day (e.g. two slices of bread, equivalent to 35g carbohydrate) and to consume low fat dairy products.
Subjects also consumed 2g control oil per day during this period.
Control oil comprised palm olein and soybean oil.
|
Subjects were asked to consume a low fat diet for 8 weeks.
Composition: 28% energy from fat, 8% energy from saturated fat, 55% energy from carbohydrate.
Subjects were provided with low fat spread, cooking oil and snacks and asked to consume these in place of normally eaten equivalent foods.
Subjects were asked to consume two extra portions of carbohydrate per day (e.g. two slices of bread, equivalent to 35g carbohydrate) and to consume low fat dairy products.
Subjects also consumed 2g control oil per day during this period.
Control oil comprised palm olein and soybean oil.
|
Experimental: High saturated fat diet
Subjects were asked to consume a high saturated fat diet for 8 weeks.
Composition: 38% energy from fat, 18% energy from saturated fat, 45% energy from carbohydrate.
Subjects were provided with spread, cooking oil and snacks and asked to consume these in place of normally eaten equivalent foods.
Subjects were asked to consume one less portion of carbohydrate per day (e.g. one slice of bread and to consume full fat dairy products.
Subjects also consumed 2g control oil per day during this period.
Control oil comprised palm olein and soybean oil.
|
Subjects were asked to consume a high saturated fat diet for 8 weeks.
Composition: 38% energy from fat, 18% energy from saturated fat, 45% energy from carbohydrate.
Subjects were provided with spread, cooking oil and snacks and asked to consume these in place of normally eaten equivalent foods.
Subjects were asked to consume one less portion of carbohydrate per day (e.g. one slice of bread and to consume full fat dairy products.
Subjects also consumed 2g control oil per day during this period.
Control oil comprised palm olein and soybean oil.
|
Experimental: High saturated fat plus DHA diet
Subjects were asked to consume a high saturated fat diet for 8 weeks.
Composition: 38% energy from fat, 18% energy from saturated fat, 45% energy from carbohydrate.
Subjects were provided with spread, cooking oil and snacks and asked to consume these in place of normally eaten equivalent foods.
Subjects were asked to consume one less portion of carbohydrate per day (e.g. one slice of bread and to consume full fat dairy products.
Subjects also consumed 6g DHA-rich oil per day during this period providing 3g DHA.
|
Subjects were asked to consume a high saturated fat diet for 8 weeks.
Composition: 38% energy from fat, 18% energy from saturated fat, 45% energy from carbohydrate.
Subjects were provided with spread, cooking oil and snacks and asked to consume these in place of normally eaten equivalent foods.
Subjects were asked to consume one less portion of carbohydrate per day (e.g. one slice of bread and to consume full fat dairy products.
Subjects also consumed 6g DHA-rich oil per day during this period providing 3g DHA.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in low density lipoprotein cholesterol (LDL-C)
Time Frame: 0, 8, 16, and 24 weeks
|
0, 8, 16, and 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in arterial stiffness
Time Frame: 0, 8, 16, 24 weeks
|
Arterial stiffness is a measure of vascular reactivity.
This was assessed by Digital Volume Pulse using Pulse Trace PCA2 Machine (Micromedical, UK)
|
0, 8, 16, 24 weeks
|
Change in fasting glucose
Time Frame: 0, 8, 16, 24 weeks
|
0, 8, 16, 24 weeks
|
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Change in fasting insulin
Time Frame: 0, 8, 16, 24 weeks
|
0, 8, 16, 24 weeks
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Change in fasting triglycerides (TAG)
Time Frame: 0, 8, 16, 24 weeks
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0, 8, 16, 24 weeks
|
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Change in C-reactive protein (CRP)
Time Frame: 0, 8, 16, 24 weeks
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0, 8, 16, 24 weeks
|
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Change in blood pressure
Time Frame: 0, 8, 16, 24 weeks
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0, 8, 16, 24 weeks
|
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Change in body weight
Time Frame: 0, 8, 16, 24 weeks
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0, 8, 16, 24 weeks
|
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Change in plasma phospholipid fatty acids
Time Frame: 0, 8, 16, 24 weeks
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0, 8, 16, 24 weeks
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Change in total cholesterol
Time Frame: 0, 8, 16, 24 weeks
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0, 8, 16, 24 weeks
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Change in high-density lipoprotein cholesterol (HDL)
Time Frame: 0, 8, 16, 24 weeks
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0, 8, 16, 24 weeks
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Change in apolipoproteins B, CIII and E
Time Frame: 0, 8, 16, 24 weeks
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0, 8, 16, 24 weeks
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Change in very low density lipoprotein (VLDL)
Time Frame: 0, 8, 16, 24 weeks
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0, 8, 16, 24 weeks
|
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Change in chylomicrons (CM)
Time Frame: 0, 8, 16, 24 weeks
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0, 8, 16, 24 weeks
|
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Change in inflammatory cytokine production
Time Frame: 9, 8, 16, 24 weeks
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9, 8, 16, 24 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Chouinard-Watkins R, Conway V, Minihane AM, Jackson KG, Lovegrove JA, Plourde M. Interaction between BMI and APOE genotype is associated with changes in the plasma long-chain-PUFA response to a fish-oil supplement in healthy participants. Am J Clin Nutr. 2015 Aug;102(2):505-13. doi: 10.3945/ajcn.114.103507. Epub 2015 Jun 17.
- Carvalho-Wells AL, Jackson KG, Lockyer S, Lovegrove JA, Minihane AM. APOE genotype influences triglyceride and C-reactive protein responses to altered dietary fat intake in UK adults. Am J Clin Nutr. 2012 Dec;96(6):1447-53. doi: 10.3945/ajcn.112.043240. Epub 2012 Nov 7.
- Lockyer S, Tzanetou M, Carvalho-Wells AL, Jackson KG, Minihane AM, Lovegrove JA. SATgenepsilon dietary model to implement diets of differing fat composition in prospectively genotyped groups (apoE) using commercially available foods. Br J Nutr. 2012 Nov 14;108(9):1705-13. doi: 10.1017/S0007114511007082. Epub 2012 Jan 16.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
October 1, 2010
Study Completion (Actual)
May 1, 2011
Study Registration Dates
First Submitted
June 20, 2011
First Submitted That Met QC Criteria
June 27, 2011
First Posted (Estimate)
June 28, 2011
Study Record Updates
Last Update Posted (Estimate)
June 28, 2011
Last Update Submitted That Met QC Criteria
June 27, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- WT085045MA
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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