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Perspective: Guidelines Needed for the Conduct of Human Nutrition Randomized Controlled Trials
Connie M Weaver, Alice H Lichtenstein, Penny M Kris-Etherton
doi : 10.1093/advances/nmaa083
Volume 12, Issue 1, January 2021, Pages 1–3
Guidelines for designing, conducting, documenting, and reporting human nutrition randomized controlled trials (RCTs) have as yet to be developed and disseminated as reference for investigators, funders, regulators, institutions, assessors, trainees, and others involved in human nutrition research. Diet-related interventions can include diet and/or behavioral manipulation, provision of foods or entire meals, or delivery of dietary components in individual food items or supplements. This Perspective introduces a series of papers that outline core principles for the design and conduct of human nutrition RCTs, documentation and reporting of all aspects of clinical trial management, and data analysis and reporting of results. Human nutrition RCTs have unique considerations delineated in these papers. Conducting them with the highest scientific rigor is essential to the development of evidence-based dietary guidance for promoting optimal health and advancing health care.
Perspective: Design and Conduct of Human Nutrition Randomized Controlled Trials
Alice H Lichtenstein, Kristina Petersen, Kathryn Barger, Karen E Hansen, Cheryl A M Anderson ...
doi : 10.1093/advances/nmaa109
Volume 12, Issue 1, January 2021, Pages 4–20
In the field of human nutrition, randomized controlled trials (RCTs) are considered the gold standard for establishing causal relations between exposure to nutrients, foods, or dietary patterns and prespecified outcome measures, such as body composition, biomarkers, or event rates. Evidence-based dietary guidance is frequently derived from systematic reviews and meta-analyses of these RCTs. Each decision made during the design and conduct of human nutrition RCTs will affect the utility and generalizability of the study results.
Perspective: US Documentation and Regulation of Human Nutrition Randomized Controlled Trials
Connie M Weaver, Naomi K Fukagawa, DeAnn Liska, Richard D Mattes, Gregory Matuszek ...
doi : 10.1093/advances/nmaa118
Volume 12, Issue 1, January 2021, Pages 21–45
Training to ensure good documentation practices and adherence to regulatory requirements in human nutrition randomized controlled trials has not been given sufficient attention. Furthermore, it is difficult to find this information conveniently organized or in a form relevant to nutrition protocols. Current gaps in training and research surveillance exist in clinical nutrition research because training modules emphasize drugs and devices, promote reliance on monitoring boards, and lack nutrition expertise on human nutrition research teams. Additionally, because eating is essential, ongoing, and highly individualized, it is difficult to distinguish risks associated with interventions from eating under free-living conditions.
Perspective: Laboratory Considerations and Clinical Data Management for Human Nutrition Randomized Controlled Trials: Guidance for Ensuring Quality and Integrity
Kevin C Maki, Joshua W Miller, George P McCabe, Gowri Raman, Penny M Kris-Etherton
doi : 10.1093/advances/nmaa088
Volume 12, Issue 1, January 2021, Pages 46–58
In human nutrition randomized controlled trials (RCTs), planning, and careful execution of clinical data collection and management are vital for producing valid and reliable results. In this article, we provide an overview of best practices for biospecimen collection and analyses, and for the fundamentals of clinical data management, including preparation and study startup; data collection, entry, cleaning, and authentication; and database lock. The reader is also referred to additional resources for information to assist in the planning and conduct of human RCTs. The tools and strategies described are expected to improve the quality of data produced in human nutrition research that can, therefore, be used to support food and nutrition policies.
Perspective: The Role of Human Breast-Milk Extracellular Vesicles in Child Health and Disease
Daniel O'Reilly, Denis Dorodnykh, Nina V Avdeenko, Nikita A Nekliudov, Johan Garssen ...
doi : 10.1093/advances/nmaa094
Volume 12, Issue 1, January 2021, Pages 59–70
Human breast milk (HM) contains multiple bioactive substances determining its impact on children's health. Extracellular vesicles (EVs) are a heterogeneous group of secreted nanoparticles that are present in HM and may be partially responsible for its beneficial effects. The precise roles and content of EVs in HM remain largely unknown. To examine this, we performed a short narrative review on the literature focusing on HM EVs to contextualize the available data, followed by a scoping review of MEDLINE and Embase databases. We identified 424 nonduplicate citations with 19 original studies included.
Protein Intake and Human Health: Implications of Units of Protein Intake
Adela Hruby, Paul F Jacques
doi : 10.1093/advances/nmaa097
Volume 12, Issue 1, January 2021, Pages 71–88
Understanding the health effects of protein intake is bedeviled by a number of factors, including protein quality and source. In addition, different units, including grams, grams per kilogram body weight (g/kg BW), and percent energy, may contribute to confusion about protein's effects on health, especially BW-based units in increasingly obese populations. We aimed to review the literature and to conduct a modeling demonstration of various units of protein intake in relation to markers of cardiometabolic health.
Intake of Sugar-Sweetened and Low-Calorie Sweetened Beverages and Risk of Cardiovascular Disease: A Meta-Analysis and Systematic Review
Jiawei Yin, Yalun Zhu, Vasanti Malik, Xiaoqin Li, Xiaolin Peng ...
doi : 10.1093/advances/nmaa084
Volume 12, Issue 1, January 2021, Pages 89–101
The long-term associations between the consumption of sugar-sweetened beverages (SSBs) and low-calorie sweetened beverages (LCSBs) with cardiovascular diseases (CVDs) remains inconsistent. To synthesize the evidence, we conducted a meta-analysis of prospective cohort studies published up to 1 December, 2019 on the associations between SSB and LCSB intake and the risk of CVD incidence and mortality. Out of 5301 articles retrieved from our literature search, 11 articles evaluating the consumption of SSBs (16,915 incident CVD cases, 18,042 CVD deaths) and 8 articles evaluating the consumption of LCSBs (18,077 incident CVD cases, 14,114 CVD deaths) were included in the meta-analysis.
Systematic Review of Beef Protein Effects on Gut Microbiota: Implications for Health
Kembra Albracht-Schulte, Tariful Islam, Paige Johnson, Naima Moustaid-Moussa
doi : 10.1093/advances/nmaa085
Volume 12, Issue 1, January 2021, Pages 102–114
The influence of diet on the gut microbiota is an emerging research area with significant impact on human health and disease. However, the effects of beef, the most consumed red meat in the United States, on gut microbial profile are not well studied. Following Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols, the objective of this systematic review was to conduct a rigorous and thorough review of the current scientific literature regarding the effects of beef protein and the resulting bioactivity of beef protein and amino acids on the gut microbiota, with the goal of identifying gaps in the literature and guiding future research priorities.
Effects of Total Red Meat Intake on Glycemic Control and Inflammatory Biomarkers: A Meta-Analysis of Randomized Controlled Trials
Lauren E O'Connor, Jung Eun Kim, Caroline M Clark, Wenbin Zhu, Wayne W Campbell
doi : 10.1093/advances/nmaa096
Volume 12, Issue 1, January 2021, Pages 115–127
Our objective was to conduct a systematic review and meta-analysis to assess the effects of total red meat (TRM) intake on glycemic control and inflammatory biomarkers using randomized controlled trials of individuals free from cardiometabolic disease.
Comparing the Effects of Docosahexaenoic and Eicosapentaenoic Acids on Inflammation Markers Using Pairwise and Network Meta-Analyses of Randomized Controlled Trials
Cécile Vors, Janie Allaire, Sonia Blanco Mejia, Tauseef A Khan, John L Sievenpiper ...
doi : 10.1093/advances/nmaa086
Volume 12, Issue 1, January 2021, Pages 128–140
Recent data from randomized clinical trials (RCTs) suggest that DHA may have stronger anti-inflammatory effects than EPA. This body of evidence has not yet been quantitatively reviewed. The aim of this study was to compare the effect of DHA and EPA on several markers of systemic inflammation by pairwise and network meta-analyses of RCTs. MEDLINE, EMBASE, and The Cochrane Library were searched through to September 2019. We included RCTs of ?7 d on adults regardless of health status that directly compared the effects of DHA with EPA and RCTs of indirect comparisons, in which the effects of DHA or EPA were compared individually to a control fatty acid.
Effects of Dose and Duration of Zinc Interventions on Risk Factors for Type 2 Diabetes and Cardiovascular Disease: A Systematic Review and Meta-Analysis
Laura M Pompano, Erick Boy
doi : 10.1093/advances/nmaa087
Volume 12, Issue 1, January 2021, Pages 141–160
No meta-analysis has examined the effect of dose and duration of zinc interventions on their impact on risk factors for type 2 diabetes (T2D) or cardiovascular disease (CVD). This study aimed first to compare the effects of zinc interventions dichotomized as low versus high dose (<25 mg/d and ?25 mg/d, respectively) and short versus long duration (<12 wk and ?12 wk, respectively) on risk factors for T2D and CVD. Second, it discusses the results from the low-dose and long-duration meta-analyses as a foundation for understanding what impact a zinc-biofortification intervention could have on these risk factors.
Effects of Dietary Glycemic Index and Glycemic Load on Cardiometabolic and Reproductive Profiles in Women with Polycystic Ovary Syndrome: A Systematic Review and Meta-analysis of Randomized Controlled Trials
Maryam Kazemi, Amir Hadi, Roger A Pierson, Marla E Lujan, Gordon A Zello ...
doi : 10.1093/advances/nmaa092
Volume 12, Issue 1, January 2021, Pages 161–178
Women with polycystic ovary syndrome (PCOS) exhibit cardiometabolic (e.g., insulin resistance) and associated reproductive disruptions. Lifestyle modification (e.g., diet) is recommended as the first-line therapy to manage PCOS; however, a favorable dietary regimen remains unclear beyond energy restriction. We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) to summarize evidence on impacts of dietary glycemic index (GI) or glycemic load (GL) on cardiometabolic and reproductive profiles to update the International Evidence-based Guideline for the Assessment and Management of PCOS.
The Effect of Aerobic and Resistance Training and Combined Exercise Modalities on Subcutaneous Abdominal Fat: A Systematic Review and Meta-analysis of Randomized Clinical Trials
Habib Yarizadeh, Reza Eftekhar, Javad Anjom-Shoae, John R Speakman, Kurosh Djafarian
doi : 10.1093/advances/nmaa090
Volume 12, Issue 1, January 2021, Pages 179–196
Subcutaneous abdominal adipose tissue (SAT), is the largest fat depot and major provider of free fatty acids to the liver. Abdominal fat is indirectly (via increased levels of low-grade inflammation) correlated with many of the adverse health effects of obesity. Although exercise is one of the most prominent components of obesity management, its effects on SAT are still unclear.
Cross-Kingdom Regulation by Plant microRNAs Provides Novel Insight into Gene Regulation
Abdul Fatah A Samad, Mohd Farizal Kamaroddin, Muhammad Sajad
doi : 10.1093/advances/nmaa095
Volume 12, Issue 1, January 2021, Pages 197–211
microRNAs (miRNAs) are well known as major players in mammalian and plant genetic systems that act by regulating gene expression at the post-transcriptional level. These tiny molecules can regulate target genes (mRNAs) through either cleavage or translational inhibition. Recently, the discovery of plant-derived miRNAs showing cross-kingdom abilities to regulate mammalian gene expression has prompted exciting discussions among researchers.
Maternal Inositol Status and Neural Tube Defects: A Role for the Human Yolk Sac in Embryonic Inositol Delivery?
Stephen W D'Souza, Andrew J Copp, Nicholas D E Greene, Jocelyn D Glazier
doi : 10.1093/advances/nmaa100
Volume 12, Issue 1, January 2021, Pages 212–222
Supplementation with myo-inositol during the periconceptional period of pregnancy may ameliorate the recurrence risk of having a fetus affected by a neural tube defect (NTD; e.g., spina bifida). This could be of particular importance in providing a means for preventing NTDs that are unresponsive to folic acid. This review highlights the characteristics of inositol and describes the role of myo-inositol in the prevention of NTDs in rodent studies and the evidence for its efficacy in reducing NTD risk in human pregnancy.
High-Fat Ketogenic Diets and Physical Performance: A Systematic Review
Nancy E Murphy, Christopher T Carrigan, Lee M Margolis
doi : 10.1093/advances/nmaa101
Volume 12, Issue 1, January 2021, Pages 223–233
Use of high-fat, ketogenic diets (KDs) to support physical performance has grown in popularity over recent years. While these diets enhance fat and reduce carbohydrate oxidation during exercise, the impact of a KD on physical performance remains controversial. The objective of this work was to assess the effect of KDs on physical performance compared with mixed macronutrient diets [control (CON)]. A systematic review of the literature was conducted using PubMed and Cochrane Library databases.
Prognostic Potential of the Preoperative Controlling Nutritional Status (CONUT) Score in Predicting Survival of Patients with Cancer: A Systematic Review
Sorayya Kheirouri, Mohammad Alizadeh
doi : 10.1093/advances/nmaa102
Volume 12, Issue 1, January 2021, Pages 234–250
The nutritional status of a patient has prognostic potency concerning short- and long-term outcomes, including survival, in many diseases. The controlling nutritional status (CONUT) score is a method for assessing nutritional status and predicting outcomes of several diseases. This study sought to systematically identify the prognostic role of preoperative CONUT score on posttreatment overall survival (OS), recurrence-free survival (RFS), and cancer-specific survival (CSS) in patients with cancer. The PubMed, SCOPUS, and Google Scholar databases and Google were searched for all dates until December 2019.
Nutrition-Sensitive Agriculture: A Systematic Review of Impact Pathways to Nutrition Outcomes
Indu K Sharma, Sabina Di Prima, Dirk Essink, Jacqueline E W Broerse
doi : 10.1093/advances/nmaa103
Volume 12, Issue 1, January 2021, Pages 251–275
The role of agriculture in reducing undernutrition is widely recognized, yet there is also consensus on the need to make the sector nutrition-sensitive. Evidence on the impact pathways from nutrition-sensitive agriculture (NSA) interventions, agricultural interventions with specific nutrition objectives, and actions detailing each temporal stage to reach nutrition outcomes is limited, however. We thus synthesized study results regarding impact of NSA interventions on nutrition outcomes relating to undernutrition, and constructed an impact pathway by mapping the evidence on each temporal stage from interventions to nutrition outcomes.
Letter to the Editor on “Comparing the Effects of Docosahexaenoic and Eicosapentaenoic Acids on Inflammation Markers Using Pairwise and Network Meta-Analyses of Randomized Controlled Trials”
Jakub Morze, Lukas Schwingshackl
doi : 10.1093/advances/nmaa128
Volume 12, Issue 1, January 2021, Pages 276–277
Reply to J Morze and L Schwingshackl
Cécile Vors, Janie Allaire, Sonia Blanco Mejia, Tauseef A Khan, John L Sievenpiper ...
doi : 10.1093/advances/nmaa131
Volume 12, Issue 1, January 2021, Pages 278–279
Comment on “The Role of Human Breast-Milk Extracellular Vesicles in Child Health and Disease”
Janos Zempleni
doi : 10.1093/advances/nmaa141
Volume 12, Issue 1, January 2021, Page 280
Reply to J Zempleni
Daniel O'Reilly, Denis Dorodnykh, Nina V Avdeenko, Nikita A Nekliudov, Johan Garssen ...
doi : 10.1093/advances/nmaa149
Volume 12, Issue 1, January 2021, Page 281
Nickel
Forrest Nielsen
doi : 10.1093/advances/nmaa154
Volume 12, Issue 1, January 2021, Pages 281–282
Advances Reviewer Acknowledgements
doi : 10.1093/advances/nmaa165
Volume 12, Issue 1, January 2021, Pages 283–285
