Study Into Genetic Influence on Cholesterol Response to Dietary Fat

NCT ID: NCT01384032

Last Updated: 2011-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2011-05-31

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.

Conditions

Cardiovascular Diseases

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Low fat diet

Intervention Type: DIETARY_SUPPLEMENT

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.

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.

Group Type: EXPERIMENTAL

Hgih saturated fat diet

Intervention Type: DIETARY_SUPPLEMENT

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.

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.

Group Type: EXPERIMENTAL

High saturated fat diet

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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 Type: 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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wellcome Trust

OTHER

Sponsor Role: collaborator

University of Reading

OTHER

Sponsor Role: lead

Responsible Party

Department of Food and Nutritional Sciences, University of Reading

Principal Investigators

Julie A Lovegrove, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Reading

Locations

Department of Food and Nutritional Sciences, University of Reading

Reading, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 26085515 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23134888 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22243632 (View on PubMed)

Other Identifiers

WT085045MA

Identifier Type: -

Identifier Source: org_study_id