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Study Into Genetic Influence on Cholesterol Response to Dietary Fat (Satgene)

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ClinicalTrials.gov Identifier: NCT01384032
Recruitment Status : Completed
First Posted : June 28, 2011
Last Update Posted : June 28, 2011
Sponsor:
Collaborator:
Wellcome Trust
Information provided by:
University of Reading

Tracking Information
First Submitted Date  ICMJE June 20, 2011
First Posted Date  ICMJE June 28, 2011
Last Update Posted Date June 28, 2011
Study Start Date  ICMJE January 2009
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2011)
Change in low density lipoprotein cholesterol (LDL-C) [ Time Frame: 0, 8, 16, and 24 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2011)
  • 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)
  • Change in fasting glucose [ Time Frame: 0, 8, 16, 24 weeks ]
  • Change in fasting insulin [ Time Frame: 0, 8, 16, 24 weeks ]
  • Change in fasting triglycerides (TAG) [ Time Frame: 0, 8, 16, 24 weeks ]
  • Change in C-reactive protein (CRP) [ Time Frame: 0, 8, 16, 24 weeks ]
  • Change in blood pressure [ Time Frame: 0, 8, 16, 24 weeks ]
  • Change in body weight [ Time Frame: 0, 8, 16, 24 weeks ]
  • Change in plasma phospholipid fatty acids [ Time Frame: 0, 8, 16, 24 weeks ]
  • Change in total cholesterol [ Time Frame: 0, 8, 16, 24 weeks ]
  • Change in high-density lipoprotein cholesterol (HDL) [ Time Frame: 0, 8, 16, 24 weeks ]
  • Change in apolipoproteins B, CIII and E [ Time Frame: 0, 8, 16, 24 weeks ]
  • Change in very low density lipoprotein (VLDL) [ Time Frame: 0, 8, 16, 24 weeks ]
  • Change in chylomicrons (CM) [ Time Frame: 0, 8, 16, 24 weeks ]
  • Change in inflammatory cytokine production [ Time Frame: 9, 8, 16, 24 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Into Genetic Influence on Cholesterol Response to Dietary Fat
Official Title  ICMJE Apolipoprotein E Genotype as a Determinant of LDL-cholesterol Response to Dietary Fat Manipulation
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Cardiovascular Diseases
Intervention  ICMJE
  • Dietary Supplement: 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.
  • Dietary Supplement: Hgih 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.
  • Dietary Supplement: 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 6g DHA-rich oil per day during this period providing 3g DHA.
Study Arms  ICMJE
  • 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.
    Intervention: Dietary Supplement: Low fat diet
  • 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.
    Intervention: Dietary Supplement: Hgih saturated fat diet
  • 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.
    Intervention: Dietary Supplement: High saturated fat diet
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 27, 2011)
88
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01384032
Other Study ID Numbers  ICMJE WT085045MA
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Professor Julie Lovegrove, Department of Food and Nutritional Sciences, University of Reading
Study Sponsor  ICMJE University of Reading
Collaborators  ICMJE Wellcome Trust
Investigators  ICMJE
Principal Investigator: Julie A Lovegrove, Professor University of Reading
PRS Account University of Reading
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP