<i>In vitro</i> and <i>in vivo</i> modeling of lipid bioaccessibility and digestion from almond muffins: The importance of the cell-wall barrier mechanism.

"Funding This research was funded by the Biotechnology and Biological Sciences Research Council (BBSRC, Grant Nos. BB/H004866/1, BB/H004874/1 and BB/H531994/1) and the University of Messina. CE was in receipt of a BBSRC-CASE award with Premier Foods as an industrial partner. We gratefully acknowledge Hughson Nut Inc (CA, US) for providing the almonds. The sponsors were not involved in any way with the research or its publication."

"A healthy volunteer was recruited by the Human Nutrition Unit at the Institute of Food Research (IFR) for a series of 8 study days (between November 2013 and February 2014), four for each muffin type, AF or AP. Only one volunteer was used to improve reproducibility between replicates. In previous studies, we found that the particle size distribution of masticated almonds is generally consistent across individuals, so this volunteer is likely to be representative of the general population (). The inclusion and exclusion criteria have been reported previously (). The mastication study received NHS ethics committee approval (10/H0717/096) and informed consent was obtained from the participant. The study was conducted in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments. The study was registered at the ISRCTN registry (ISRCTN58438021). On each study day the volunteer was asked to masticate half a muffin (110 g) and custard (40 g) and expectorate each mouthful when they felt the urge to swallow. Each frozen muffin was cut vertically in half; one half was defrosted at 4 °C the day before the study day, the remaining half was kept frozen (-20 °C) until needed. Mastication of the test meals took 3 min 22 s and 6 min 38 s on average for the AF and AP muffins, respectively. During mastication, the volunteer produced 21.8 g ± 4.2 and 35.8 g ± 3.3 of saliva for the AF and AP muffins, respectively. This study had participant recruitment and screening in common with the study described by Edwards et al., with the aim of recruiting 8–10 healthy participants with ileostomies (). The participants were eligible if they had undergone a proctocolectomy for ulcerative colitis, lower bowel cancer or pure colonic Crohn’s disease and had normal stoma function for at least one year previously. Other inclusion criteria included: no allergy to almonds or other test meal ingredients; no previous obstruction of the stoma; BMI in the range 20–35 kg m−2; no mouth, throat or GI problem (other than ileostomy); total serum cholesterol <7.8 mmol L−1; serum triacylglycerol (TAG) <3 mmol L−1; plasma glucose <7 mmol L−1; and liver function and blood cell counts within prescribed limits. These were assessed using a screening questionnaire and full medical examination. All screening and study visits took place at the Clinical Research Facility at St Thomas’ Hospital, London, UK between November 2012 and April 2013. The stopping guidelines for this study included clinical review of any participant who experienced adverse events (such as blockages), and discussion within the study team as to whether that adverse event posed sufficient risk to future participants to warrant early termination of the study. The study received NHS ethics committee approval (12/LO/1016) and informed consent was obtained from all participants. The study was conducted in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments. The study was registered at the ISRCTN registry (ISRCTN40517475)."