Considerations for the design and conduct of human gut microbiota intervention studies relating to foods
Considerations for the design and conduct of human gut microbiota intervention studies relating to foods
With the growing appreciation for the influence of the intestinal microbiota on human health, there is increasing motivation to design and refine interventions to promote favorable shifts in the microbiota and their interactions with the host. Technological advances have improved our understanding and ability to measure this indigenous population and the impact of such interventions. However, the rapid growth and evolution of the field, as well as the diversity of methods used, parameters measured and populations studied, make it difficult to interpret the significance of the findings and translate their outcomes to the wider population. This can prevent comparisons across studies and hinder the drawing of appropriate conclusions. This review outlines considerations to facilitate the design, implementation and interpretation of human gut microbiota intervention studies relating to foods based upon our current understanding of the intestinal microbiota, its functionality and interactions with the human host. This includes parameters associated with study design, eligibility criteria, statistical considerations, characterization of products and the measurement of compliance. Methodologies and markers to assess compositional and functional changes in the microbiota, following interventions are discussed in addition to approaches to assess changes in microbiota-host interactions and host responses. Last, EU legislative aspects in relation to foods and health claims are presented. While it is appreciated that the field of gastrointestinal microbiology is rapidly evolving, such guidance will assist in the design and interpretation of human gut microbiota interventional studies relating to foods.
Foods, Gut bacteria, Human studies, Intestinal microbes, Microbiome, Microbiota, Prebiotics, Probiotics
3347-3368
Swann, J.R.
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Rajilic-Stojanovic, M.
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Salonen, A.
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Sakwinska, O.
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Gill, C.
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Meynier, A.
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Fança-Berthon, P.
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Schelkle, B.
79be8fe5-f2b7-487f-9b62-17fec23bee3e
Segata, N.
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Shortt, C.
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Tuohy, K.
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Hasselwander, O.
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December 2020
Swann, J.R.
7c11a66b-f4b8-4dbf-aa17-ad8b0561b85c
Rajilic-Stojanovic, M.
7c8e1f5a-d9cc-4af1-8ce4-2c735197f0b0
Salonen, A.
fee2bca5-a431-44df-b566-24275937b2d8
Sakwinska, O.
e5423954-ba96-4065-8a34-8520e2dbb6bc
Gill, C.
11bbe58e-e88f-4530-9311-bea8996986ad
Meynier, A.
87f7e56c-be92-4244-bd07-06a844e91b63
Fança-Berthon, P.
5534f123-0ed8-4ce9-841a-75375fcd5577
Schelkle, B.
79be8fe5-f2b7-487f-9b62-17fec23bee3e
Segata, N.
96dc7f37-62ee-4672-b141-971ba5d543c4
Shortt, C.
729da927-8090-435d-9c00-7c48b911c09d
Tuohy, K.
c68343d9-e2d4-4609-b75b-40289a34bf70
Hasselwander, O.
cce23b7f-aec2-4849-8fcb-18a4c477efe8
Swann, J.R., Rajilic-Stojanovic, M., Salonen, A., Sakwinska, O., Gill, C., Meynier, A., Fança-Berthon, P., Schelkle, B., Segata, N., Shortt, C., Tuohy, K. and Hasselwander, O.
(2020)
Considerations for the design and conduct of human gut microbiota intervention studies relating to foods.
European Journal of Nutrition, 59 (8), .
(doi:10.1007/s00394-020-02232-1).
Abstract
With the growing appreciation for the influence of the intestinal microbiota on human health, there is increasing motivation to design and refine interventions to promote favorable shifts in the microbiota and their interactions with the host. Technological advances have improved our understanding and ability to measure this indigenous population and the impact of such interventions. However, the rapid growth and evolution of the field, as well as the diversity of methods used, parameters measured and populations studied, make it difficult to interpret the significance of the findings and translate their outcomes to the wider population. This can prevent comparisons across studies and hinder the drawing of appropriate conclusions. This review outlines considerations to facilitate the design, implementation and interpretation of human gut microbiota intervention studies relating to foods based upon our current understanding of the intestinal microbiota, its functionality and interactions with the human host. This includes parameters associated with study design, eligibility criteria, statistical considerations, characterization of products and the measurement of compliance. Methodologies and markers to assess compositional and functional changes in the microbiota, following interventions are discussed in addition to approaches to assess changes in microbiota-host interactions and host responses. Last, EU legislative aspects in relation to foods and health claims are presented. While it is appreciated that the field of gastrointestinal microbiology is rapidly evolving, such guidance will assist in the design and interpretation of human gut microbiota interventional studies relating to foods.
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More information
Accepted/In Press date: 18 March 2020
e-pub ahead of print date: 3 April 2020
Published date: December 2020
Additional Information:
Funding Information:
This work was conducted by an expert group of the European branch of the International Life Sciences Institute, ILSI Europe. The expert group and this publication were coordinated and funded by the Health Benefits Assessment of Foods Task Force. Industry members of this task force are listed on the ILSI Europe website at https://ilsi.eu/task-forces/nutrition/functional-foods/ . The research reported is the result of a scientific evaluation in line with ILSI Europe’s framework to provide a precompetitive setting for public–private partnership (PPP). The opinions expressed herein and the conclusions of this publication are those of the authors and do not necessarily represent the views of ILSI Europe nor those of its member companies.
Publisher Copyright:
© 2020, The Author(s).
Keywords:
Foods, Gut bacteria, Human studies, Intestinal microbes, Microbiome, Microbiota, Prebiotics, Probiotics
Identifiers
Local EPrints ID: 439408
URI: http://eprints.soton.ac.uk/id/eprint/439408
ISSN: 1436-6207
PURE UUID: 9c16f51d-0b58-4f47-902e-a1702be8a58a
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Date deposited: 21 Apr 2020 16:52
Last modified: 17 Mar 2024 04:00
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Contributors
Author:
M. Rajilic-Stojanovic
Author:
A. Salonen
Author:
O. Sakwinska
Author:
C. Gill
Author:
A. Meynier
Author:
P. Fança-Berthon
Author:
B. Schelkle
Author:
N. Segata
Author:
C. Shortt
Author:
K. Tuohy
Author:
O. Hasselwander
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