Best practices for the design, laboratory analysis, and reporting of trials involving fatty acids

Abstract

Fatty acids are among the most studied nutrients in human metabolism and health. Endogenous fatty acid status influences health and disease via multiple mechanisms at all stages of the life cycle. Despite widespread interest, attempts to summarize the results of multiple studies addressing similar fatty acid–related outcomes via meta-analyses and systematic reviews have been disappointing, largely because of heterogeneity in study design, sampling, and laboratory and data analyses. Our purpose is to recommend best practices for fatty acid clinical nutrition and medical studies. Key issues in study design include judicious choice of sampled endogenous pools for fatty acid analysis, considering relevant physiologic state, duration of intervention and/or observation, consideration of specific fatty acid dynamics to link intake and endogenous concentrations, and interpretation of results with respect to known fatty acid ranges. Key laboratory considerations include proper sample storage, use of sample preparation methods known to be fit-for-purpose via published validation studies, detailed reporting or methods to establish proper fatty acid identification, and quantitative analysis, including calibration of differential response, quality control procedures, and reporting of data on a minimal set of fatty acids to enable comprehensive interpretation. We present a checklist of recommendations for fatty acid best practices to facilitate design, review, and evaluation of studies with the intention of improving study reproducibility.

Human milk fatty acid profile across lactational stages after term and preterm delivery: A pooled data analysis

“…SCFAs and most MCFAs contribute relatively little to the overall fat content of HM, and especially SCFAs are seldomly reported in the included studies. Only one of the included studies reported SCFA butyric acid (C4:0) in term HM, possibly because in other studies analytical methods to measure HMFAs may not adapted to measure these highly volatile FA methyl esters [54,55].…”

Improving natural product research translation: From source to clinical trial

“…6,[19][20][21][22][23][24][25][26][27] As was done for a recent workshop focused on fatty acids, 28 we assemble here relevant prior publications citing critical or state-of-the-art approaches drawn from a breadth of NP research and related disciplines, and address in greater depth NP-related topics that were specific foci of the workshop. Past efforts to enhance rigor in NP research include the NCCIH Policy on Natural Product Integrity 18 as well as numerous guidance documents addressing identification, reproducibility, study design, and execution, as well as conflict of interest issues.…”

“…Past efforts to enhance rigor in NP research include the NCCIH Policy on Natural Product Integrity 18 as well as numerous guidance documents addressing identification, reproducibility, study design, and execution, as well as conflict of interest issues. 6,[19][20][21][22][23][24][25][26][27] As was done for a recent workshop focused on fatty acids, 28 we assemble here relevant prior publications citing critical or state-of-the-art approaches drawn from a breadth of NP research and related disciplines, and address in greater depth NP-related topics that were specific foci of the workshop.…”

Omega-3 PUFA metabolism and brain modifications during aging

“…Hence, it is difficult to draw a clear conclusion for the omega-3 fatty acid results in RBC but it appears that at older ages, there is more omega-3 in RBC. It is important to note that these papers did not include a complete fatty acid profile of the RBC as it was recently recommended in a paper describing the best practices for the design, laboratory analysis and reporting of clinical trials involving fatty acids 51 , hence limiting comparisons between studies. With respect to plasma/serum PL, there were eight studies 45,[52][53][54][55][56][57][58] .…”