NUTR 670 GMU Nutrition Research Methods Randomized Controlled Trial Worksheet This is a Nutrition Research Methods Course (NUTR 670) The attached Word doc

NUTR 670 GMU Nutrition Research Methods Randomized Controlled Trial Worksheet This is a Nutrition Research Methods Course (NUTR 670)

The attached Word document contains the Homework 1 questions. You will also find a PDF research article and CONSORT checklist file that will be necessary to answer the questions.

Also, I attached all the PowerPoint slides that you MUST read and review before/during when you answering the questions PLUS watch the videos on the links below:

https://library.gmu.edu/tutorials/student-tutorials

I need Correct, High quality and professional answers”

Please, you MUST read and review all the Guidelines files which I attached before you start to answer the questions and you can use them while you answering the questions especially Questions 2 and 3.

PLEASE, DO NOT use any British words and vocabularies, JUST the U.S. words.

When you answer the question points in paragraphs way make sure that you answer all questions.

If you feel that you can not do this homework as well professionally as exactly required, please, do not accept the order from the first second.

Regards, Name __________________________
NUTR 670 Homework 1 (WEEKS 1,2,3,4,5 & 6)
1) Evaluating a Randomized Controlled Trial
The following research article describes the use of a randomized controlled trial to
evaluate the impact of adding lean red meat to a Mediterranean-style diet on risk factors
for cardiometabolic disease (which includes cardiovascular disease).
O’Connor LE, Paddon-Jones D, Wright AJ, Campbell WW. A Mediterranean-style
eating pattern with lean, unprocessed red meat has cardiometabolic benefits for
adults who are overweight or obese in a randomized, crossover, controlled
feeding trial. Am J Clin Nutr. 2018;108(1):33-40. doi:10.1093/ajcn/nqy075
Read the article and answer the following questions about it:
a) Complete the CONSORT checklist by identifying where each item number
appears in the published article. The checklist is included as a separate Word
doc with the Homework. (We did not practice using the checklist in class, but we
did talk about most of the items on the checklist. If you’re having trouble, I
recommend reviewing the documents on the CONSORT website
http://www.consort-statement.org, especially the “CONSORT 2010 Explanation
and Elaboration Document”.) Upload your completed checklist with your
homework submission. (15%)
Please type your answer here in blue (or some other bright color) text, so it’s easy for
me to spot them.
b) Provide a critical review of the study. There is no specific formula to follow,
but here are some items you may want to consider in your review; you may also
find the CONSORT review to help in your review. I anticipate your review will
be approximately 1 page, but can be longer. (30%)
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•
•
•
•
•
•
Does the research design fit the stated purpose of the study?
Have the authors included all relevant topics in the background? (Does
the background information provide sufficient justification and rationale for
this study? Have the authors omitted any relevant information to ‘spin’
their story?)
Do you recognize any intolerable sources of bias in the study design?
Are all major confounding variables controlled for in the study design?
Are the methods of data collection appropriate for the study outcomes?
Were the methodological limitations acknowledged and discussed?
What influence might these limitations have on the results?
•
•
•
What is the real-world significance of these results, and (how) does this
differ from the statistical significance?
Are the authors’ conclusions supported by the data?
Conclude with your overall assessment of what the impact of the study
could/should be.
Please type your answer here in blue (or some other bright color) text, so it’s easy for
me to spot them.
c) Using the information provided in the article, locate this trial on
www.clinicaltrials.gov . Review this information; you’ll sometimes notice that
there is some different information available on this website (or that the
information is presented differently), as compared to the published peer-reviewed
research article. Describe any differences you observe, and if/how these
differences impact your assessment of the published research article.
(10%)
Please type your answer here in blue (or some other bright color) text, so it’s easy for
me to spot them.
d) The authors provided a general hypothesis in their article, but they did not
provide a fully conceived research question, null hypothesis, and alternative
hypothesis as we have discussed at length in class. Re-write their research
question, null hypothesis and alternative hypothesis according to the
criteria discussed in class. (10%)
Please type your answer here in blue (or some other bright color) text, so it’s easy for
me to spot them.
e) The authors chose a crossover study design for their RCT. Describe the
advantages and disadvantages of using a crossover trial, as compared to a
parallel arm design. Use specific examples from this study where possible in
your answer. (10%)
Please type your answer here in blue (or some other bright color) text, so it’s easy for
me to spot them.
(more on the next page)
2) Library Guest Lecture (10%)
Name two library resources that Kathy Butler discussed that are available to you
(other than Zotero) and provide a brief description of (1) what they are/do and (2)
how they can be useful to you in your coursework and/or your future practice as a
nutritionist.
Please type your answer here in blue (or some other bright color) text, so it’s easy for
me to spot them.
3) Nutrition Research Importance (15%)
Imagine that you’re visiting with a family member or friend over the break, and they
ask about your progress toward a nutrition degree. You naturally tell them that
Nutrition Research Methods is your favorite class. Upon hearing this, they begin to
complain about how they don’t appreciate that their tax dollars are being used to
support nutrition research. After taking a deep breath and a moment to collect your
thoughts, you respond by describing all the important reasons why nutrition
research is important to our society and thus warrants spending public funds.
Write that response here.
Please type your answer here in blue (or some other bright color) text, so it’s easy for
me to spot them.
Lauren E O’Connor,1 Douglas Paddon-Jones,2 Amy J Wright,1 and Wayne W Campbell1
1 Department
of Nutrition Science, Purdue University, West Lafayette, IN and 2 Department of Nutrition and Metabolism, University of Texas Medical Branch,
Galveston, TX
ABSTRACT
Background: A Mediterranean-style eating pattern (Mediterranean
Pattern) is often described as being low in red meat. Research shows
that lean, unprocessed red meat can be incorporated into healthy eating patterns to improve cardiometabolic disease (CMD) risk factors.
Objective: We assessed the effects of consuming different amounts
of lean, unprocessed red meat in a Mediterranean Pattern on CMD
risk factors. We hypothesized that consuming a Mediterranean Pattern would improve CMD risk factors and that red meat intake would
not influence these improvements.
Design: In an investigator-blinded, randomized, crossover, controlled feeding trial, 41 subjects [mean ± SD age: 46 ± 2 y; mean
± SD body mass index (kg/m2 ): 30.5 ± 0.6] were provided with
a Mediterranean Pattern for two 5-wk interventions separated by
4 wk of self-selected eating. The Mediterranean Patterns contained
∼500 g [typical US intake (Med-Red)] and ∼200 g [commonly recommended intake in heart-healthy eating patterns (Med-Control)]
of lean, unprocessed beef or pork per week. Red meat intake was
compensated by poultry and other protein-rich foods. Baseline and
postintervention outcomes included fasting blood pressure, serum
lipids, lipoproteins, glucose, insulin, and ambulatory blood pressure.
The presented results were adjusted for age, sex, and body mass at
each time point (P < 0.05). Results: Total cholesterol decreased, but greater reductions occurred with Med-Red than with Med-Control (−0.4 ± 0.1 and −0.2 ± 0.1 mmol/L, respectively, intervention × time = 0.045]. Low-density lipoprotein decreased with Med-Red but was unchanged with MedControl [−0.3 ± 0.1 and −0.1 ± 0.1 mmol/L, respectively, intervention × time = 0.038], whereas high-density lipoprotein (HDL) concentrations decreased nondifferentially [−0.1 ± 0.0 mmol/L]. Triglycerides, total cholesterol:HDL, glucose, and insulin did not change with either Med-Red or Med-Control. All blood pressure parameters improved, except during sleep, independent of the red meat intake amount. Conclusions: Adults who are overweight or moderately obese may improve multiple cardiometabolic disease risk factors by adopting a Mediterranean-style eating pattern with or without reductions in red meat intake when red meats are lean and unprocessed. This trial was registered at clinicaltrials.gov as NCT02573129. Am J Clin Nutr 2018;108:33–40. Keywords: beef, pork, healthy eating pattern, blood lipids, blood lipoproteins, blood pressure INTRODUCTION The historically low chronic disease rates in Mediterranean countries are often attributed to eating habits. In the 1960s, a Mediterranean-style eating pattern (Mediterranean Pattern) was first recognized in a small cohort of coastal Greek olive farmers who had lower rates of cardiovascular disease than six other world regions (1). Their eating pattern was predominantly plantbased, notably low in red meat, and olive oil was the main source of fat (2). The health-promoting properties of a Mediterranean Pattern, including reduced risk of developing cardiovascular disease and type 2 diabetes, are supported by recent and larger studies (3–7). These recent studies, including the Prevención con Dieta Mediterránea (PREDIMED) (5) and Seguimiento Universidad de Navarra (SUN) cohorts (8), were largely conducted on This study was funded in part by the Beef Checkoff, the Pork Checkoff, the National Institute of Health’s Ingestive Behavior Research Center at Purdue University (5T32DK076540-08), and the National Institute of Health’s Indiana Clinical and Translational Sciences Institute. These organizations had no role in the design or conduct of the study; collection, analysis, or interpretation of the data; or writing of the manuscript. Supplemental Tables 1–4 and Supplemental Figure 1 are available from the “Supplementary data” link in the online posting of the article and from the same link in the online table of contents at https://academic.oup.com/ajcn/. Address correspondence to WWC (e-mail: campbellw@purdue.edu). Abbreviations used: ApoB, apolipoprotein B; CMD, cardiometabolic disease; CRP, C-reactive protein; DASH, Dietary Approaches to Stop Hypertension; DGAC, Dietary Guidelines Advisory Committee; LS, least squares; Med-Control, Mediterranean-style eating pattern with ∼200 g of lean, unprocessed red meat per week; Mediterranean Pattern, Mediterranean-style eating pattern; Med-Red, Mediterranean-style eating pattern with ∼500 g of lean, unprocessed red meat per week; PREDIMED, Prevención con Dieta Mediterránea; total-C, total cholesterol. Received December 29, 2017. Accepted for publication March 21, 2018. First published online June 13, 2018; doi: https://doi.org/10.1093/ajcn/ nqy075. Am J Clin Nutr 2018;108:33–40. Printed in USA. © 2018 American Society for Nutrition. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited. 33 Downloaded from https://academic.oup.com/ajcn/article-abstract/108/1/33/5036105 by guest on 03 March 2020 A Mediterranean-style eating pattern with lean, unprocessed red meat has cardiometabolic benefits for adults who are overweight or obese in a randomized, crossover, controlled feeding trial 34 O’CONNOR ET AL. METHODS Experimental design This experimental design was a 16-wk randomized, crossover, investigator-blinded, controlled feeding study. Subjects consumed a Mediterranean Pattern for two 5-wk controlled feeding interventions separated by at least 4 wk of a self-selected and unrestricted eating pattern (washout). Dietary intake, body mass and composition, and CMD risk factors [including total cholesterol (total-C), LDL cholesterol, HDL cholesterol, totalC:HDL cholesterol, total apolipoprotein B (ApoB), triglycerides, glucose, insulin, HOMA-IR, C-reactive protein (CRP), fasting blood pressure, ambulatory blood pressure, and the Framingham Heart Study 10-y cardiovascular disease risk and vascular age] were measured at both baselines and during the last week of each Mediterranean Pattern intervention. Randomization was completed using an online randomization plan generator (http://www.randomization.com/). The trial was registered at clinicaltrials.gov as NCT02573129. Subjects Subjects who were overweight or obese [BMI (kg/m2 ) 25– 37], aged 30–69 y [representing middle-aged adults and adulthood life stage groups of the Dietary Reference Intakes (19)], and not already following a Mediterranean Pattern [as indicated by a score of Purchase answer to see full attachment