Omega-3 and Hyperlipidemia Management

Introduction

The people with borderline hyperlipidaemia are those individuals who are the verge of developing a high level of cholesterol in the blood. As mentioned by Blom et al. (2018), people with hyperlipidaemia are prone to get affected by cardiovascular complications. This is because the presence of high cholesterol in the blood leads to deposition of the fats within the walls of the arteries which narrows the width of the arteries that slow down or in intense cases block the normal flow of blood to the heart. It interferes with the proper working of the heart raising cardiovascular complications. However, it is been found that omega-3 polysaturated fatty acids supplements reduce the amount of cholesterol in the blood helping individuals with borderline hyperlipidaemia to control the amount of triglycerides in the blood, in turn, avoiding risk of cardiovascular diseases (Song et al. 2018). The information is evident as in the study of Zibaeenezhad et al. (2017) the research executed informed that out of 48 patients who are suffering from hyperlipidaemia when put under omega-3 polysaturated fatty acids supplements each showed reduction in their level of triglycerides and non-HDL cholesterol in their blood. In the study of Zehr and Walker (2018), it is informed that combination of omega-3 polyunsaturated fatty acids supplements along with statins have an improved effect on increasing the endothelial function as well as decreasing the triglycerides compared to the reaction of only statin in case of hyperlipidemia. This study used individuals who are suffering from hyperlipidaemia and initially treated them with rouvastain+ EPA(eicosapentaenoic acid)+DHA(docosahexaenoic acid) who were in group 1 and only rosuvastatin who were in group 2. After 4 weeks, the triglycerides were considerably reduced in group 1 compared to the baseline data received. However, after the omega-3 fatty acid supplement was stopped it showed an increased level of triglycerides among the individuals. Thus, this study indicated that the effect of omega-3 polyunsaturated fatty acids supplements on individuals with hyperlipidemia is that it reduces the lipid content in the blood orienting them to live a better life out of the risk of cardiovascular and other diseases involved with hyperlipidemia, which can be crucial for those seeking healthcare dissertation help.

The omega-3 polyunsaturated fatty acids supplements include fresh fish such as Mackerel, Salmon and others; fish oil, oysters and others (Kuszewski et al. 2017). The study of Zibaeenezhad et al. (2017) informed that fresh fish is more effective in lowering and controlling triglycerides levels or lipid profiles in the blood compared to fish oil. This is evident as the survey from the study informed that LDL that is low-density lipid which rises in the blood leads to deposition of cholesterol was considerably reduced in individuals who ate fresh-fish compared to people who took omega-3 polysaturated capsules (+18.7 ± 24.97 vs. −22.75 ± 27.28, P < 0.001). Moreover, the study of Ooi et al. (2012) informed that a study conducted by involving 20 people showed that all them, when provided a diet rich in fresh dish, is a dietary supplement of omega-3- polyunsaturated fatty acids over 24 weeks reported reduction in concentration of lipoproteins, LDL as well as HDL. Thus, it can be ensured from the studies that omega-3 polysaturated supplements such as dietary-fish are more effective in controlling cholesterol level in the blood compared to the capsules as supplements. In contrast to the previous study, the study of Arca et al. (2018) highlighted the mechanism of the effect of omega-3 polysaturated fatty acids in controlling LDL and/or triglycerides level in the blood that determines the lipid profile of a person on borderline hyperlipidaemia or hyperlipidaemia or low lipidaemia. The study informed that omega-3 polysaturated fatty acids act to lower the regulation and production of hepatic VLDL (very low-density lipoprotein). The lipoproteins are seen to be made up of proteins, triglycerides and cholesterol which moves the lipids and fats in the body and VLDL being one of the key lipoproteins (Cicero and Colletti, 2018). Thus, lowering the production of VLDL would lower the lipid profile of people with borderline hyperlipidaemia which makes them less prone to have risk of developing cardiovascular disease and other health issues that they could have been affected if their lipid profiles in the blood are not reduced. The study of Karalis (2017), informed that omega-3 polysaturated fatty acids lower the level of non-esterified fatty acids which is delivered to the liver through increased regulation of the β-oxidation of the fatty acids present in the adipose tissues, skeletal muscles, heart and liver. This results the body to store few fatty acids intracellularly as well as lower the release back of increased fatty acids in the circulation. In comparison to the study, the article byShearer et al. (2012) informed that the omega-3 polysaturated fatty acids in peripheral tissues increase the uptake mechanism of fatty acids in the skeletal muscles, cardiac cells and adipocytes along with actions to reduce lipolytic release of non-esterified fatty acids which are produced from adipose tissue. This results in lowering the increased development of lipoproteins in the blood avoiding build-up of cholesterol or fats and others in the circulation and arteries.

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The studies indicated that omega-3 polyunsaturated fatty acids supplements have better effect on patients who are suffering from hyperlipidemia by reducing the level of triglycerides and other lipoprotein in the blood. However, most of the studies are till now is seen to be conducted on patients who have hyperlipidemia to understand the effect of omega-3 polyunsaturated fatty acids on them rather than focussing on individuals and their lipid profiles who are at the borderline of hyperlipidemia. Thus, this study will be conducted to understand the effect of omega-3 polyunsaturated fatty acids supplements on lipid profiles of people with borderline hyperlipidemia to understand the way the supplements act to control their condition and make them safe from facing health risks.

Research Questions

What is the effect of omega-3 fatty acids supplements on the lipid profile of people with borderline level of hyperlipidaemia?

Hypothesis

Alternative Hypothesis:

The consumption of Omega-3 fatty Acid supplementations will reduce total cholesterol, LDL, Triglyceride and increase the HDL in people who are at borderline state of hyperlipidaemia.

Null Hypothesis:

The consumption of Omega-3 fatty Acid supplementations does not have impacts on total lipid profile in people who are at borderline state of hyperlipidaemia

Aims

The aim is to identify the effect of omega-3 fatty acids supplements on the lipid profile of people with borderline level of hyperlipidaemia.

Objectives

To recruit free-disease people with same age group, and who are at the borderline level of total cholesterol, LDL and triglycerides

Divided the participants to two groups randomly to an intervention group, who will receive the omega-3 supplement as an intervention, and a control group who will receive placebo.

Assess the lipid profile at the beginning of the study by taking a blood sample of fasting state and after 8 weeks period.

Data include age, gender, eating habit, physical lifestyle and diet history will be collected from a baseline survey for both groups

Healthy diet instructions will be given for both groups from the dietitian following the Eat well guide as the study will carry out in the UK.

Data analysis for both groups will be done by using different methods for quantitative data and qualitative data

The final finding will be published in nutrition and health science journals and will share it in health-related conferences

Research Design/ Methodology

The study will be a randomised double-blind trial and mixed methods will be used for gathering information in the study. As asserted by Al-Lamee et al. (2018), randomised double-blind trial studies is the study in which neither participants nor the researcher knows who is going to receive the treatment as per the provided evidence in the study. This is executed to prevent rise of bias in the results developed in the study. As argued by Lawton et al. (2017), randomised control trial studies include allocation of participants which are often predictable. This results in development of selection bias when the groups are unmasked for gathering information. Thus, the randomised double-blind trail study will be used for executing the research because errors that are developed due to rise of bias as a result of placebo effect or demand characteristics can be prevented. As mentioned by Hesse-Biber (2016), mixed methods are those in which the research is executed by gathering, evaluating and integrating qualitative and quantitative research. The mixed methods will be used in this study because it helps to resolve the weakness of qualitative and quantitative research when either of them is used in conducting studies. Moreover, the combination of both the methods in mixed methods would help to reduce biases made by the researcher while using single methodologies (Holden et al. 2015). During the use of mixed methods, the qualitative information that will be collected would mention the mechanism and way through which omega-3 polystaurated fatty acid supplements affect the lipid profile of people with borderline hyperlipidemia to prevent them from the risk of cardiovascular and other diseases. The quantitative information that will be collected would mention the amount of reduction or increase in the lipid profile of the people in the borderline of hyperlipidemia. The qualitative results would connect with the quantitative results in the sense that the qualitative data will be effective to explain in words about the way omega-3 fatty acids are able to reduce the figures of the lipid profile of the people with borderline hyperlipidemia to protect them from cardiovascular diseases. (Refer to Appendix 1)

Subjects

In this study, total of 80 participants will be included who are above the age of 19 years. Moreover, the participants will be chosen who are reported to have recently figured out that they are suffering from high cholesterol, LDL or Triglyceride at borderline level and are referred for diet control along with they are also required to be healthy in nature meaning they should not have any cardiovascular disease. The participants with any history of disease would be excluded.

Plan of investigation

Sampling Strategy

The researcher will use stratified sampling strategy which is type of probability sampling method to gather participants for the study that represent the population from which they are selected. In probability sampling, the participants are randomly chosen who often represent the entire population (Alzahrani et al. 2016). The advantage of the method is that it is cost-effective and involves less judgement in selecting participants. Thus, out of 100 population based on the criteria mentioned in the subject section 80 participants are finalised for the study as the other 20 participants were seen to have history of other diseases that interfere with hyperlipidemia. As mentioned by Rothnie et al. (2016), in stratified random sampling strategy the collected sample is divided into different groups on the basis of their characteristics. The study on the basis of stratified sampling strategy which is type of probability sampling with divide the 80 participants equally into two groups in which the participants in Group 1 will be offered 2 capsules/day omega-3 supplements "containing eicosapentaenoic acid 2160 mg and docosahexaenoic acid 1440 mg” (Dasarathy, et al, 2016) whereas Group 2 will include rest 40 participants who will be treated as control group. The baseline data will be taken at the beginning of study and same data will be taken at the end to compare the data. In the middle of the experiment in week 4, blood test will be taken for lipid profile for both groups in order to compare the results more critically. The qualitative data will be collected by interviewing 5 dieticians to understand the mechanism of the effect of omega-3 polyunsaturated fatty acids supplements on lipid profile of people with borderline hyperlipidemia. The use of the qualitative and quantitative data in the process would help to understand whether or not in real omega-3 polyunsaturated fatty acids supplements reduce lipid content in the body of the people with borderline hyperlipidemia.

Allocation

The enrolled participants will be randomized by using stratified randomization which will be used to specify all variable in equal way except the Omega-3 supplements which are the intervention we are interested in this study. ( Kim and Shin, 2014) In order to make sure that the randomization will be correct, software Excel will be used (Betterevaluation.org, n.d.). The 40 subjects will allocated to intervention group who will follow a healthy diet plan from dietician and omega-3 supplements however the control group will receive a placebo and the same diet instruction.

Recruitment:

Patients who visit the GP and after doing a blood test they diagnosed of having risk for high cholesterol level at borderline level, but they do not need to start taking medication. The people will be contacted either by telephone or by email to discuss the research study. All the study details will be explained to the people. If they accept to participate, written informed consent will be given to them to read and sign. They will be asked to complete questionnaires to collect data, even though their data will be in the medical profile, it will be double check by asking them in the questioner. Lab test will be done on first day of the study and then will be taken after 8 weeks. The qualitative data from the dieticians will to be collected by interviewing them through a semi-structured questionnaire. The advantage of semi-structured interview over structured interview is that in the former the participants are allowed to inform data with freedom in their own terms to enrich the execution of the study which is not allowed in the later (Kallio et al. 2016). The dieticians are to be interviewed by using telephone and Skype.

Inclusion criteria

Inclusion criteria

Exclusion criteria:

Exclusion criteria

Procedure

Procedure

Data collection

All people will be evaluated by using baseline questionnaire, which they will be given before the dietitian interview. In addition, body analysis data such as fat mass, lean mass, intercellular, and extracellular water will be collected from body composition analysis device like InBody720 as the information would help the dietitian to provide a suitable diet plan. The survey will include closed-end question and some information, which will be taken from medical profile such as age, gender and disease history to double check the data. Medical profile, lab report will be done at the beginning to collect the lipid profile result, total cholesterol, LDL, HDL, triglyceride. The interview transcripts developed while interviewing the participants will be collected to develop data for further analysis.

Data analysis

The questionnaire data will be recorded to convert it to numerical data and then will be carried out statistically by using SPSS which will be clear to find out the relationship between omega-3 supplements and lipid profile. The data collected at the beginning of the study from blood test results, medical profile and questionnaire will be analysis and compare with the data after the end of 8 weeks to. The Open-ended question will be categorised to themes and any other extra information added from the participants will be coded after collecting the data. The interview transcripts will be analysed by the researchers and an in-depth study will be done to identify key data and results by evaluating the feelings and expression of the participants presented in the transcripts for developing themes to represent the qualitative results.

Beneficiaries of the study

Patients life quality: The information developed from the study will be helpful to lead the people with borderline hyperlipidemia to have statistical proof along with theoretical understand of the mechanism through which intake of omega-3 fatty acids supplements will benefit them in controlling the lipid profile to normal for avoiding risk of cardiovascular disease.

Dieticians: The dieticians will be benefited from the study to provide evidential proof to the patients regarding the way intake of proper amount of omega-3 fatty acids supplements will help them to avoid unnecessary level of lipid profile.

Food industries: The food industries will be benefited from the study to understand the importance of including omega-3 fatty acids supplements in their products as well as be able to provide evidence to the consumers about the advantage of intake of their products, in turn, increasing the sales of their products properly.

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Ethical Concerns

This study will be carry out after obtaining approval by the NHS in the UK because it required to have access to the participants' medical profile, and lab result report. All the participants are to be clarified about short and long terms aims and objective of the study before signing the informed consent. In case, any individual wishes to leave the survey or interview in the middle the person is allowed to do so without facing any opposition from the researcher. In order to maintain ethical concern, the diet plan that will be shared in the study would to be generalised and it will mentioned. Moreover, it will be mentioned that the plan needs to be evaluated by each individuals with their personal GP to ensure it is effective for them to control their lipid profile before adopting it in real life. (Refer to Appendix 3)

Methods of Dissemination

Publication would be sort of health science of human nutrition and dietetics journals and the data will be presented at health-related conferences to share the findings.

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References

Al-Lamee, R., Thompson, D., Dehbi, H.M., Sen, S., Tang, K., Davies, J., Keeble, T., Mielewczik, M., Kaprielian, R., Malik, I.S. and Nijjer, S.S., (2018). Percutaneous coronary intervention in stable angina (ORBITA): a double-blind, randomised controlled trial. The Lancet, 391(10115), pp.31-40.

Alzahrani, T.A., Abaalkhail, B.A. and Ramadan, I.K., (2016). Prevalence of intimate partner violence and its associated risk factors among Saudi female patients attending the primary healthcare centers in Western Saudi Arabia. Saudi medical journal, 37(1), p.96.

Arca, M., Borghi, C., Pontremoli, R., De Ferrari, G.M., Colivicchi, F., Desideri, G. and Temporelli, P.L., (2018). Hypertriglyceridemia and omega-3 fatty acids: Their often overlooked role in cardiovascular disease prevention. Nutrition, Metabolism and Cardiovascular Diseases, 28(3), pp.197-205.

Blom, W.A., Koppenol, W.P., Hiemstra, H., Stojakovic, T., Scharnagl, H. and Trautwein, E.A., (2018). A low-fat spread with added plant sterols and fish omega-3 fatty acids lowers serum triglyceride and LDL-cholesterol concentrations in individuals with modest hypercholesterolaemia and hypertriglyceridaemia. European journal of nutrition, pp.1-10.

Hesse-Biber, S., (2016). Doing interdisciplinary mixed methods health care research: working the boundaries, tensions, and synergistic potential of team-based research. Qualitative health research, 26(5), pp.649-658.

Holden, R.J., Eriksson, A., Andreasson, J., Williamsson, A. and Dellve, L., (2015). Healthcare workers' perceptions of lean: A context-sensitive, mixed methods study in three Swedish hospitals. Applied ergonomics, 47, pp.181-192.

Kallio, H., Pietilä, A.M., Johnson, M. and Kangasniemi, M., (2016). Systematic methodological review: developing a framework for a qualitative semi‐structured interview guide. Journal of advanced nursing, 72(12), pp.2954-2965.

Karalis, D.G., (2017). A review of clinical practice guidelines for the management of hypertriglyceridemia: a focus on high dose omega-3 fatty acids. Advances in therapy, 34(2), pp.300-323.

Kuszewski, J., Wong, R. and Howe, P., (2017). Effects of long-chain Omega-3 polyunsaturated fatty acids on endothelial vasodilator function and cognition—Are they interrelated?. Nutrients, 9(5), p.487.

Lawton, R., O'hara, J.K., Sheard, L., Armitage, G., Cocks, K., Buckley, H., Corbacho, B., Reynolds, C., Marsh, C., Moore, S. and Watt, I., (2)017. Can patient involvement improve patient safety? A cluster randomised control trial of the Patient Reporting and Action for a Safe Environment (PRASE) intervention. BMJ Qual Saf, 26(8), pp.622-631.

Ooi, E.M., Lichtenstein, A.H., Millar, J.S., Diffenderfer, M.R., Lamon-Fava, S., Rasmussen, H., Welty, F.K., Barrett, P.H.R. and Schaefer, E.J., (2012). Effects of therapeutic lifestyle change diets high and low in dietary fish-derived FAs on lipoprotein metabolism in middle-aged and elderly subjects. Journal of lipid research, 53(9), pp.1958-1967.

Rothnie, K.J., Müllerová, H., Hurst, J.R., Smeeth, L., Davis, K., Thomas, S.L. and Quint, J.K., (2016). Validation of the recording of acute exacerbations of COPD in UK primary care electronic healthcare records. PLoS One, 11(3), p.e0151357.

Shearer, G.C., Savinova, O.V. and Harris, W.S., (2012). Fish oil—how does it reduce plasma triglycerides?. Biochimica et Biophysica Acta (BBA)-Molecular and Cell Biology of Lipids, 1821(5), pp.843-851.

Song, J., Hu, M., Li, C., Yang, B., Ding, Q., Wang, C. and Mao, L., (2018). Dose-dependent effects of fish oil on cardio-metabolic biomarkers in healthy middle-aged and elderly Chinese people: a double-blind randomized controlled trial. Food & function, 9(6), pp.3235-3243.

Zehr, K.R. and Walker, M.K., (2018). Omega-3 polyunsaturated fatty acids improve endothelial function in humans at risk for atherosclerosis: A review. Prostaglandins & other lipid mediators, 134, pp.131-140.

Zibaeenezhad, M.J., Ghavipisheh, M., Attar, A. and Aslani, A., (2017). Comparison of the effect of omega-3 supplements and fresh fish on lipid profile: a randomized, open-labeled trial. Nutrition & diabetes, 7(12), p.1.

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