Overview:You are asked to construct a “mock” research article using the results provided to you.
Your research team has conducted a single-blinded, randomized controlled clinical trial in people with type 2 diabetes. Participants were randomized to either a very low carbohydrate, ketogenic diet or a low fat diet. Both diets were hypo energetic, and involved the same degree of total dietary energy restriction. Patients were followed up at 12 months to investigate the primary outcome measure of long term glucose control (HbA1c). More details on the specifics of the study are provided in the Methods section below.
HSN301 Diet And Disease Assignment-Deakin University Australia
The maximum word count for the assignment is 2000 words(excluding references, tables, figures, figure legends and table captions).
Note that a methods section is not required in this assignment, but is provided to you for your information.
Learning outcomes of this assignment:
The Unit Learning Outcomes associated with this assignment are:
ULO1: Explain the aetiology and patho physiology of common nutrition-related diseases. In this research articles, you should demonstrate a good understanding of the pathophysiology of type 2 diabetes; as well as the clinical biomarkers of the disease. You should demonstrate a good understanding of how they may respond to dietary interventions.
ULO3: Search, interpret and critically evaluate scientific publications on the relationship between diets and nutrition-related diseases. In this assignment, you will be given details on the methods and key findings of a clinical trial. Using the given information to write your research article, you will demonstrate good skills in:searching for appropriate reference articles; accurately interpreting those identified studies; and critically evaluating them in the context of relationships between diet and disease.
ULO4: Synthesise current scientific knowledge on the prevention (treatment) of nutrition-related diseases and produce reports for a professional and lay audience You will learn to synthesize information from current scientific publications to provide strong background, rationale and discussion of results in this research article. You will also learn to use language suitable for a research article.
The following information describes the major requirements of each section of the assignment. Use this in conjunction with the other support materials provided to get the most out of this assignment.
Components of a research article
A. TITLE: Do not exceed two lines – 100 characters including spaces
Titles should include sufficient detail for indexing purposes (on databases such as PubMed), but also be general enough for readers outside the field to appreciate what the paper is about.
B. ABSTRACT
Typically, an abstract provides one or two lines regarding the importance and context of the current work, a statement of aims, a brief description of the methods, the major findings which include a summary of the data e.g. in an intervention study what factors changed and degree of change and a conclusion. This is often difficult to fit into such a brief number of words. You can however, assume a large amount of previous knowledge in terms of background and methodology on behalf of the reader. This allows you to focus more on what new information the current article is presenting. The abstract should not contain any undefined abbreviations or unspecified references.
HSN301 Diet And Disease Assignment-Deakin University Australia
C. INTRODUCTION
Your introduction should provide a brief but relevant literature review that places the importance of this study within the context of the current literature. While the included information will be specific to the topic, you can funnel your logical flow of ideas down from a “more general” level to a “more specific” level relevant to your aims.
A suggested structure for your writing in this section is as follows:
- Include prevalence/statistical data to outline the burden of type 2 diabetes
- Describe the major clinical and pathophysiological aspects of type 2 diabetes
- Describe the importance of dietary management for type 2 diabetes
- What is the proposed benefits and/or mechanisms of very low carbohydrate ketogenic diets in the management of type 2 diabetes?
- What biomarkers would be expected to be altered with reductions in the carbohydrate content of the diet?
- What previous research has been conducted on the topic and where does the focus of this study fit into that research area (research gaps)?
- What are the aims of this study? (note: aims have been provided for you)
METHODS
There is no need to include this section in your assignment.
D: RESULTS AND DISCUSSION
RESULTS:
Results should be succinctly summarised. You should firstly provide a brief description of the final sample population. You should summarize you findings clearly and concisely, regardless of whether your outcomes measures changed significantly or not during the intervention. The results section is an important one to consider as it provides you with a list and the structure of what you need to focus on within your discussion.
DISCUSSION:
Your discussion needs to be succinct, providing a critique of work undertaken within the Current article, highlighting the major findings and the importance of the results in terms of the intervention. You should discuss whether the results would be expected when compared results of other relevant studies. You should provide a summary of the possible physiological mechanisms that may explain the study results. Discuss the significance of the work and how this information adds to the scientific body of knowledge (i.e. why should other researchers and the general population care). You should also consider the strengths and potential limitations of this study, the general is ability of results, and the future research directions following on from this work.
A suggested structure for your writing which follows the overall theme and structure of the article is:
- Provide a succinct summary of the key results
- How do these findings fit within the context of the current literature? What do these findings add to the current literature?
- Based on evidence and data, how do you think the intervention acted to change the outcome measures? (if in fact it did; and if it didn’t, why might this be?)
- Is the magnitude of effect observed consistent with a clinical benefit? Note that statistical significance does not automatically equate to clinical importance. This is an important point, as it will be an important consideration for whether or not the dietary intervention is a candidate treatment to translate into practice.
- What were some strengths of the study design, methods and data found? What might have been some potential limitations of the study?
- Given possible limitations of the study and/or new questions raised in relation to the findings, what future investigations might be useful to further explore this topic?
HSN301 Diet And Disease Assignment-Deakin University Australia
E. CONCLUSIONS
A final conclusion is different from that presented in the abstract. It should be a touch wordier and is really your final say regarding the importance of the major outcome(s) of this work and how this information can be used for the common good (e.g. as a therapeutic aid to a particular pathology). Don’t overstate your achievements – for example, by claiming you have cured cancer (unless you have indeed done this!). A conclusion should never present new ideas or results that have not been described previously within the results and discussion.
F: RESEARCH TRANSLATION
A very important part of scientific research (particularly health-based research) is to highlight the importance of your work in a simple, yet succinct manner that is understandable to a non-specific health professional audience. You should summarise the main implications of your findings as they pertain to potential translate ability to the clinic, public health and/or policy (whichever is most relevant to your research). You should provide your summary as a text box within your article. The use of bullet points is recommended: a maximum of 4 points should be included. No references are required.
You need to keep the language simple without losing the impact of your findings, or, on the flip-side, without over-stating your findings. Note that this section may include repeating some of the same information you have already included in your discussion and/or conclusions.
Methods and results of a randomized, controlled trial
Aim
The aim of this study is to assess the effects of a low carbohydrate ketogenic diet on glycaemic control (HbA 1c ), insulin sensitivity, body weight, fat mass, and metabolic indicators of inflammation and cardiovascular health in obese individuals with type 2 diabetes.
Methods
Study design:
This was a single-blinded, randomized controlled, parallel-arm study consisting of two study groups.
Study population:
Male and female participants aged over 18 years were recruited from the community via newspaper study advertisements. To be eligible for the study, the participants had to have: (a) diagnosed type 2 diabetes; and (b) a BMI greater than 30 kg.m -2 . Participants who were already diagnosed with cardiovascular diseases, renal diseases, neurological diseases or musculoskeletal disorders were excluded from the study. Individuals who had body weight fluctuations of >5 kg over the last 3 months or were following a weight loss diet were also excluded. Volunteers who met all inclusion criteria were enrolled and randomly assigned into one of the two study groups.
Study groups:
Following phone screening and clinical screening of potential participants, n=160 individuals were deemed eligible to participate. Participants were randomized to either a VLCKD or a low fat diet for 12 months. Both diet groups consumed low-energy diets that were is o energetic, but with differences in macro nutrient percentages. Participants on the VLCKD consumed a diet consisting of approximately 10% carbohydrate, 20% protein and 70% fat. Participants on the low fat diet consumed approximately 60% carbohydrate, 20% protein and 20% fat. All participants were asked to maintain their usual physical activity levels throughout the study to avoid potentially confounding effects. Physical activity recall surveys were performed every 3 months to monitor activity. Participants from both groups received dietary counselling from qualified dietitians every 4 weeks to ensure compliance to the diets. Compliance with diet was assessed using: 1) 3-monthly self-reported 7-day weighed diet records; and 2) ketone concentrations in blood and urine taken every 3 months.
HSN301 Diet And Disease Assignment-Deakin University Australia
Outcome measures:
All measurements were taken at baseline, 6 months and 12 months of the study.The primary outcome measure was glycated haemoglobin (HbA 1c ), which was measured from whole blood samples using High Performance Liquid Chromatography.Secondary outcomes included body weight, body mass index (BMI), and body composition, including lean mass and fat mass measured using dual-energy x-ray absorptiometry (DXA). Plasma outcome measures included markers of inflammation,insulin sensitivity, and cardiovascular health. Fasting blood samples (after 10 hours of overnight fasting) were collected from participants in EDTA blood tubes. Inflammation markers included fasting plasma C-reactive protein (CRP), tum or necrosis factor alpha(TNF-α), interleukin-6 (IL-6) and adiponectin were assessed. Fasting plasma glucose and insulin were measured, from which homeostatic model assessment (HOMA-IR) was determined and used to estimate insulin sensitivity. Cardiovascular health indicators measured were blood pressure, fasting plasma triglycerides, total cholesterol, LDL-cholesterol and HDL-cholesterol levels.
Statistical Analysis:
The normality of data was confirmed using Shapiro-Wilk tests. At baseline, study outcomes of participants in the VLCKD and low fat groups were compared using independent-sample t-tests and no significant differences were shown. Changes in all study outcome measurements from baseline through to 12 months (baseline, 6 months, 12 months) were compared between the VLCKD and low fat groups using repeated measures A NOVA with Bonferroni corrections. Statistical significance was determined at alpha of 5%, i.e. p<0.05, two-sided. Statistical analyses were performed using SPSS version 24.0 software. Data are presented as mean ± SD.
Results (summary of data, without a description)
Table 1. Dietary intake characteristics over 12 months (data are mean ± SD)
(*denotes statistically different between diets at the time point, p<0.05; †denotes statistically different when compared to baseline [time=0], p<0.05)
Figure 2. Effect of diets on HbA1c over 12 months. Data are mean ± SD (*denotes statistically different means between diets at the time point, p<0.05; †denotes statistically different mean when compared to baseline [time=0], p<0.05)
Table 2. Effect of different diets on secondary outcome measures (data are mean ± SD)
(*denotes statistically different between diets at the time point, p<0.05; †denotes statistically different when compared to baseline [time=0], p<0.05; SBP – systolic blood pressure; DBP – diastolic blood pressure; CRP- C-Reactive protein; TNF-α – tumor necrosis factor-alpha; IL-6 – Interleukin-6; HOMA-IR – homeostatic model assessment for insulin resistance; trigs – triglycerides)
HSN301 Diet And Disease Assignment-Deakin University Australia
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