Crossover Designs in Nutrition and Dietetics Research

Harris, Jeffrey E.; Raynor, Hollie A.

doi:10.1016/j.jand.2017.03.017

Cited by 17 publications

(12 citation statements)

References 18 publications

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“…The FRESH study design has several strengths. First a randomized cross-over trial where each person acts as their own control is an efficient design and prevents contamination that often occurs in parallel arm trials [ 27 ]. Second, participants are free-living and consume their own foods and maintain personal food preferences, which maximizes compliance [ 20 ].…”

Section: Discussionmentioning

confidence: 99%

Rationale and design of the frequency of eating and Satiety Hormones (FRESH) study: A randomized cross-over clinical trial

Neuhouser¹,

Clowry²,

Beatty³

et al. 2019

Contemporary Clinical Trials Communications

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Background The goal of the Frequency of Eating and Satiety Hormones (FRESH) Study is to understand the relationship between eating frequency (EF) and biomarkers of appetite and disease risk. This report gives the study rationale and design. Methods The FRESH study was conducted in n = 50 overweight and obese, but otherwise healthy, male and female adults aged 18–50 years. The protocol included four in-person clinic visits for protocol instruction, blood draws, anthropometry, and meal testing; all other activities were done at home. Participants completed two 21-day phases in random order with a two-week washout between phases. One phase was high EF (6 eating occasions/day) and the other was low EF (3 eating occasions/day). Each phase specified time of day for each eating occasion. Participants prepared their own meals throughout the study using study-provided individualized, structured meal plans ensuring that calories, macronutrients and micronutrients were identical during both study phases. Fasting blood was collected before and after each phase to test intervention effects on the biomarkers. At the end of each phase participants also completed extended appetite testing with meals prepared by the study clinic. Results Participants were recruited using print, radio, and digital ads. 60 participants consented to enroll; 10 dropped out due to work or school scheduling conflicts and 50 (target sample size) completed the study. Compliance was assessed by completion of daily on-line meal plan checklists. Conclusions The FRESH study will provide data on whether higher vs. lower daily EF in the context of constant energy and nutrient intake may be harmful or beneficial based on intervention effects on biomarkers of health and disease risk.

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Section: Discussionmentioning

confidence: 99%

Rationale and design of the frequency of eating and Satiety Hormones (FRESH) study: A randomized cross-over clinical trial

Neuhouser¹,

Clowry²,

Beatty³

et al. 2019

Contemporary Clinical Trials Communications

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show abstract

“…In this type of design, the same animal is sampled multiple times, and it can be a powerful approach for several reasons. First, the possibility of confounding due to differences between the experimental groups is eliminated (46,56). Second, microbiomes tend to be more consistent within an individual than between individuals, so a crossover approach will typically have lower variance (49,50).…”

Section: Crossover Designsmentioning

confidence: 99%

“…For example, clearing an animal of parasitic infection, performing a surgical procedure, or altering immune functions with treatments such as vaccines, will be guaranteed to have carryover effects. Crossover designs are best suited to studying chronic problems, and are particularly ideal for diet research (55,56).…”

Section: Crossover Designsmentioning

confidence: 99%

“…If there is reason to suspect that carryover will be an issue, switching to a parallel design, adding a run-in period, or extending the treatment period as appropriate are all preferable to trying to correct carryover effects in the analysis phase (55)(56)(57). A washout is a period without treatment or with a control treatment that allows the effects of a previous intervention to wane, and its length should be based on what is known about the duration of effect of the intervention (55).…”

Section: Crossover Designsmentioning

confidence: 99%

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Best Practices for Microbiome Study Design in Companion Animal Research

Jarett¹,

Kingsbury²,

Dahlhausen³

et al. 2021

Front. Vet. Sci.

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The gut microbiome is a community of microorganisms that inhabits an animal host's gastrointestinal tract, with important effects on animal health that are shaped by multiple environmental, dietary, and host-associated factors. Clinical and dietary trials in companion animals are increasingly including assessment of the microbiome, but interpretation of these results is often hampered by suboptimal choices in study design. Here, we review best practices for conducting feeding trials or clinical trials that intend to study the effects of an intervention on the microbiota. Choices for experimental design, including a review of basic designs, controls, and comparison groups, are discussed in the context of special considerations necessary for microbiome studies. Diet is one of the strongest influences on the composition of gut microbiota, so applications specific to nutritional interventions are discussed in detail. Lastly, we provide specific advice for successful recruitment of colony animals and household pets into an intervention study. This review is intended to serve as a resource to academic and industry researchers, clinicians, and veterinarians alike, for studies that test many different types of interventions.

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“…In this approach, baseline and postprandial biological samples are collected for analysis and for identifying potential biomarkers. For these dietary interventions, the use of crossover studies is an efficient design having less bias and requiring less sample size than randomized parallel group intervention trials [ 14 ]. In crossover studies, participants receive all interventions in consecutive periods, which means that the influence of individual variation is minimized.…”

Section: Introductionmentioning

confidence: 99%

Ultra-Performance Liquid Chromatography-Ion Mobility Separation-Quadruple Time-of-Flight MS (UHPLC-IMS-QTOF MS) Metabolomics for Short-Term Biomarker Discovery of Orange Intake: A Randomized, Controlled Crossover Study

et al. 2020

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A major problem with dietary assessments is their subjective nature. Untargeted metabolomics and new technologies can shed light on this issue and provide a more complete picture of dietary intake by measuring the profile of metabolites in biological samples. Oranges are one of the most consumed fruits in the world, and therefore one of the most studied for their properties. The aim of this work was the application of untargeted metabolomics approach with the novel combination of ion mobility separation coupled to high resolution mass spectrometry (IMS-HRMS) and study the advantages that this technique can bring to the area of dietary biomarker discovery, with the specific case of biomarkers associated with orange consumption (Citrus reticulata) in plasma samples taken during an acute intervention study (consisting of a randomized, controlled crossover trial in healthy individuals). A total of six markers of acute orange consumption, including betonicines and conjugated flavonoids, were identified with the experimental data and previous literature, demonstrating the advantages of ion mobility in the identification of dietary biomarkers and the benefits that an additional structural descriptor, as the collision cross section value (CCS), can provide in this area.

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Crossover Designs in Nutrition and Dietetics Research

Cited by 17 publications

References 18 publications

Rationale and design of the frequency of eating and Satiety Hormones (FRESH) study: A randomized cross-over clinical trial

Rationale and design of the frequency of eating and Satiety Hormones (FRESH) study: A randomized cross-over clinical trial

Best Practices for Microbiome Study Design in Companion Animal Research

Ultra-Performance Liquid Chromatography-Ion Mobility Separation-Quadruple Time-of-Flight MS (UHPLC-IMS-QTOF MS) Metabolomics for Short-Term Biomarker Discovery of Orange Intake: A Randomized, Controlled Crossover Study

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