Affordable Access

deepdyve-link
Publisher Website

The challenges of control groups, placebos and blinding in clinical trials of dietary interventions.

Authors
  • Staudacher, Heidi M1
  • Irving, Peter M1
  • Lomer, Miranda C E1
  • Whelan, Kevin1
  • 1 King's College London,Diabetes and Nutritional Sciences Division,London SE1 9NH,UK.
Type
Published Article
Journal
Proceedings of The Nutrition Society
Publisher
Cambridge University Press
Publication Date
Aug 01, 2017
Volume
76
Issue
3
Pages
203–212
Identifiers
DOI: 10.1017/S0029665117000350
PMID: 28629483
Source
Medline
Keywords
License
Unknown

Abstract

High-quality placebo-controlled evidence for food, nutrient or dietary advice interventions is vital for verifying the role of diet in optimising health or for the management of disease. This could be argued to be especially important where the benefits of dietary intervention are coupled with potential risks such as compromising nutrient intake, particularly in the case of exclusion diets. The objective of the present paper is to explore the challenges associated with clinical trials in dietary research, review the types of controls used and present the advantages and disadvantages of each, including issues regarding placebos and blinding. Placebo-controlled trials in nutrient interventions are relatively straightforward, as in general placebos can be easily produced. However, the challenges associated with conducting placebo-controlled food interventions and dietary advice interventions are protean, and this has led to a paucity of placebo-controlled food and dietary advice trials compared with drug trials. This review appraises the types of controls used in dietary intervention trials and provides recommendations and nine essential criteria for the design and development of sham diets for use in studies evaluating the effect of dietary advice, along with practical guidance regarding their evaluation. The rationale for these criteria predominantly relate to avoiding altering the outcome of interest in those delivered the sham intervention in these types of studies, while not compromising blinding.

Report this publication

Statistics

Seen <100 times