Eric Hentges

Human gut microbiota and its relationship to health and disease

Probiotics are live microorganisms that confer a health benefit on the host when administered in appropriate amounts. Over 700 randomized, controlled, human studies have been conducted with probiotics thus far, with the results providing strong support for the use of probiotics in the clinical prevention or treatment of gastrointestinal tract disorders and metabolic syndrome. The present review is based on webinar presentations that were developed by the American Gastroenterological Association (AGA) in partnership with the International Scientific Association for Probiotics and Prebiotics (ISAPP) and the North American branch of the International Life Sciences Institute (ILSI North America). The presentations provided gastroenterologists and researchers with fundamental and current scientific information on the influence of gut microbiota on human health and disease, as well as clinical intervention strategies and practical guidelines for the use of probiotics and prebiotics.

Funding food science and nutrition research: financial conflicts and scientific integrity

There has been significant public debate about the susceptibility of research to biases of various kinds. The dialogue has extended to the peer-reviewed literature, scientific conferences, the mass media, government advisory bodies, and beyond. Whereas biases can come from myriad sources, the overwhelming focus of the discussion to date has been on industry-funded science. Given the critical role that industry has played and will continue to play in the research process, the International Life Sciences Institute (ILSI) North America Working Group on Guiding Principles has, in this article, proposed conflict-of-interest guidelines regarding industry funding to protect the integrity and credibility of the scientific record, particularly with respect to health, nutrition, and food-safety science. Eight principles are enumerated, which specify the ground rules for industry-sponsored research. This article, which issues a challenge to the broader scientific community to address all bias issues, is only a first step; the document is intended to be dynamic, prompting ongoing discussion and refinement. In the conduct of public/private research relationships, all relevant parties shall 1) conduct or sponsor research that is factual, transparent, and designed objectively, and, according to accepted principles of scientific inquiry, the research design will generate an appropriately phrased hypothesis and the research will answer the appropriate questions, rather than favor a particular outcome; 2) require control of both study design and research itself to remain with scientific investigators; 3) not offer or accept remuneration geared to the outcome of a research project; 4) ensure, before the commencement of studies, that there is a written agreement that the investigative team has the freedom and obligation to attempt to publish the findings within some specified time frame; 5) require, in publications and conference presentations, full signed disclosure of all financial interests; 6) not participate in undisclosed paid authorship arrangements in industry-sponsored publications or presentations; 7) guarantee accessibility to all data and control of statistical analysis by investigators and appropriate auditors/reviewers; 8) require that academic researchers, when they work in contract research organizations (CRO) or act as contract researchers, make clear statements of their affiliation; and require that such researchers publish only under the auspices of the CRO.

Integrating the Totality of Food and Nutrition Evidence for Public Health Decision Making and Communication

The interpretation and integration of epidemiological studies detecting weak associations (RR <2) with data from other study designs (e.g., animal models and human intervention trials) is both challenging and vital for making science-based dietary recommendations in the nutrition and food safety communities. The 2008 ILSI North America “Decision-Making for Recommendations and Communication Based on Totality of Food-Related Research” workshop provided an overview of epidemiological methods, and case-study examples of how weak associations have been incorporated into decision making for nutritional recommendations. Based on the workshop presentations and dialogue among the participants, three clear strategies were provided for the use of weak associations in informing nutritional recommendations for optimal health. First, enable more effective integration of data from all sources through the use of genetic and nutritional biomarkers; second, minimize the risk of bias and confounding through the adoption of rigorous quality-control standards, greater emphasis on the replication of study results, and better integration of results from independent studies, perhaps using adaptive study designs and Bayesian meta-analysis methods; and third, emphasize more effective and truthful communication to the public about the evolving understanding of the often complex relationship between nutrition, lifestyle, and optimal health.

Principles for building public-private partnerships to benefit food safety, nutrition, and health research

The present article articulates principles for effective public-private partnerships (PPPs) in scientific research. Recognizing that PPPs represent one approach for creating research collaborations and that there are other methods outside the scope of this article, PPPs can be useful in leveraging diverse expertise among government, academic, and industry researchers to address public health needs and questions concerned with nutrition, health, food science, and food and ingredient safety. A three-step process was used to identify the principles proposed herein: step 1) review of existing PPP guidelines, both in the peer-reviewed literature and at 16 disparate non-industry organizations; step 2) analysis of relevant successful or promising PPPs; and step 3) formal background interviews of 27 experienced, senior-level individuals from academia, government, industry, foundations, and non-governmental organizations. This process resulted in the articulation of 12 potential principles for establishing and managing successful research PPPs. The review of existing guidelines showed that guidelines for research partnerships currently reside largely within institutions rather than in the peer-reviewed literature. This article aims to introduce these principles into the literature to serve as a framework for dialogue and for future PPPs.

Achieving a transparent, actionable framework for public-private partnerships for food and nutrition research

Officers and other representatives of more than a dozen food-, nutrition-, and health-related scientific societies and organizations, food industry scientists, and staff of the USDA, the CDC, the Food and Drug Administration, and the NIH convened on 8 December 2014 in Washington, DC, to reach a consensus among individuals participating on guiding principles for the development of research-oriented, food- and nutrition-related public-private partnerships. During the daylong working meeting, participants discussed and revised 12 previously published guidelines to ensure integrity in the conduct of food and nutrition research collaborations among public, nonprofit, and private sectors. They agreed to reconvene periodically to reassess the public-private partnership principles. This article presents the guiding principles and potential benefits, outlines key discussion points, and articulates points of agreement and reservation.

Funding food science and nutrition research: financial conflicts and scientific integrity.

There has been significant public debate about the susceptibility of research to biases of various kinds. The dialogue has extended to the peer-reviewed literature, scientific conferences, the mass media, government advisory bodies, and beyond. While biases can come from myriad sources, the overwhelming focus of the discussion, to date, has been on industry-funded science. Given the critical role that industry has played and will continue to play in the research process, the International Life Sciences Institute (ILSI) North America Working Group on Guiding Principles has, in this paper, set out proposed conflict-of-interest guidelines, regarding industry funding, for protecting the integrity and credibility of the scientific record, particularly with respect to health, nutrition, and food-safety science. Eight principles are enumerated, specifying ground rules for industry-sponsored research. The paper, which issues a challenge to the broader scientific community to address all bias issues, is only a first step; the document is intended to be dynamic, prompting ongoing discussion and refinement. The Guiding Principles are as follows. In the conduct of public/private research relationships, all relevant parties shall: 1) conduct or sponsor research that is factual, transparent, and designed objectively; according to accepted principles of scientific inquiry, the research design will generate an appropriately phrased hypothesis and the research will answer the appropriate questions, rather than favor a particular outcome; 2) require control of both study design and research itself to remain with scientific investigators; 3) not offer or accept remuneration geared to the outcome of a research project; 4) prior to the commencement of studies, ensure that there is a written agreement that the investigative team has the freedom and obligation to attempt to publish the findings within some specified time-frame; 5) require, in publications and conference presentations, full signed disclosure of all financial interests; 6) not participate in undisclosed paid authorship arrangements in industry-sponsored publications or presentations; 7) guarantee accessibility to all data and control of statistical analysis by investigators and appropriate auditors/reviewers; and 8) require that academic researchers, when they work in contract research organizations (CRO) or act as contract researchers, make clear statements of their affiliation; require that such researchers publish only under the auspices of the CRO.

How experts are chosen to inform public policy: can the process be improved?

The ever-increasing complexity of the food supply has magnified the importance of ongoing research into nutrition and food safety issues that have significant impact on public health. At the same time, ethical questions have been raised regarding conflict of interest, making it more challenging to form the expert panels that advise government agencies and public health officials in formulating nutrition and food safety policy. Primarily due to the growing complexity of the interactions among government, industry, and academic research institutions, increasingly stringent conflict-of-interest policies may have the effect of barring the most experienced and knowledgeable nutrition and food scientists from contributing their expertise on the panels informing public policy. This paper explores the issue in some depth, proposing a set of principles for determining considerations for service on expert advisory committees. Although the issues around scientific policy counsel and the selection of advisory panels clearly have global applicability, the context for their development had a US and Canadian focus in this work. The authors also call for a broader discussion in all sectors of the research community as to whether and how the process of empaneling food science and nutrition experts might be improved.

Public-Private Partnerships: The Evolving Role of Industry Funding in Nutrition Research

The global burdens of morbidity and mortality associated with obesity-related chronic diseases are crippling public health and are predicted to exponentially increase over the next 3 decades. Meanwhile, the resources necessary to conduct research that may offer solutions to the obesity epidemic continue to decline and funding has become increasingly difficult to secure. Alternative models for funding nutrition and health research are necessary to make considerable and timely progress to improve public health. Key stakeholders include, but are not limited to, government agencies, foundations, private industry, and nongovernmental organizations.

Key attributes of global partnerships in food and nutrition to align research agendas and improve public health.

Partnerships among academia, government, and industry have emerged in response to global challenges in food and nutrition. At a workshop reviewing international partnerships, we concluded that to build a partnership, partners must establish a common goal, identify barriers, and engage all stakeholders to ensure project sustainability. To be effective, partnerships must synchronize methodologies and adopt evidence-based processes, and be led by governmental or nonprofit organizations to ensure trust among partners and with the public.