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

This study has been completed.
Sponsor:
Collaborator:
Wellcome Trust
Information provided by:
University of Reading
ClinicalTrials.gov Identifier:
NCT01384032
First received: June 20, 2011
Last updated: June 27, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
Cardiovascular Diseases
Dietary Supplement: Low fat diet
Dietary Supplement: Hgih saturated fat diet
Dietary Supplement: High saturated fat diet

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Apolipoprotein E Genotype as a Determinant of LDL-cholesterol Response to Dietary Fat Manipulation

Resource links provided by NLM:


Further study details as provided by University of Reading:

Primary Outcome Measures:
  • Change in low density lipoprotein cholesterol (LDL-C) [ Time Frame: 0, 8, 16, and 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in arterial stiffness [ Time Frame: 0, 8, 16, 24 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Change in fasting insulin [ Time Frame: 0, 8, 16, 24 weeks ] [ Designated as safety issue: No ]
  • Change in fasting triglycerides (TAG) [ Time Frame: 0, 8, 16, 24 weeks ] [ Designated as safety issue: No ]
  • Change in C-reactive protein (CRP) [ Time Frame: 0, 8, 16, 24 weeks ] [ Designated as safety issue: No ]
  • Change in blood pressure [ Time Frame: 0, 8, 16, 24 weeks ] [ Designated as safety issue: No ]
  • Change in body weight [ Time Frame: 0, 8, 16, 24 weeks ] [ Designated as safety issue: No ]
  • Change in plasma phospholipid fatty acids [ Time Frame: 0, 8, 16, 24 weeks ] [ Designated as safety issue: No ]
  • Change in total cholesterol [ Time Frame: 0, 8, 16, 24 weeks ] [ Designated as safety issue: No ]
  • Change in high-density lipoprotein cholesterol (HDL) [ Time Frame: 0, 8, 16, 24 weeks ] [ Designated as safety issue: No ]
  • Change in apolipoproteins B, CIII and E [ Time Frame: 0, 8, 16, 24 weeks ] [ Designated as safety issue: No ]
  • Change in very low density lipoprotein (VLDL) [ Time Frame: 0, 8, 16, 24 weeks ] [ Designated as safety issue: No ]
  • Change in chylomicrons (CM) [ Time Frame: 0, 8, 16, 24 weeks ] [ Designated as safety issue: No ]
  • Change in inflammatory cytokine production [ Time Frame: 9, 8, 16, 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 88
Study Start Date: January 2009
Study Completion Date: May 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.
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.
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.

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01384032

Locations
United Kingdom
Department of Food and Nutritional Sciences, University of Reading
Reading, United Kingdom, RG6 6AP
Sponsors and Collaborators
University of Reading
Wellcome Trust
Investigators
Principal Investigator: Julie A Lovegrove, Professor University of Reading
  More Information

No publications provided by University of Reading

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Professor Julie Lovegrove, Department of Food and Nutritional Sciences, University of Reading
ClinicalTrials.gov Identifier: NCT01384032     History of Changes
Other Study ID Numbers: WT085045MA
Study First Received: June 20, 2011
Last Updated: June 27, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Reading:
CVD, LDL-C, apoE, SFA, DHA

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 28, 2014