Clinical trial NCT02497768: Particle Sizing of Masticated Tree Nuts - Pistachios and Brazils
Official title: Particle Sizing of Masticated Tree Nuts - Pistachios and Brazils
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: mastication
pistachios
brazils
participants
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2015-07-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The investigators want to understand how oral processing (chewing) of nuts affects particle size and the presence of lipid (fat) on the cut surfaces.

The main objective of the study is to:

Measure the size of nut particles that have been chewed sufficiently to be swallowed.

The secondary objective of this study is to:

Measure any changes in lipid content due to chewing and compare it to a prediction from a theoretical model.

The investigators have developed a theoretical model for determining the release of nutrients from plant foods, specifically lipid (fat) from almonds. The model has been used to calculate the amount of lipid released from chewed almonds. The model shows that only about 10% of the lipid is immediately released. The investigators require information on the particle size distribution (number of particles of each size) for other chewed nuts to calculate the amount of lipid released for other nuts. This will allow us to check the validity of our model for other foods.


Eligibility criteria: Inclusion Criteria:

* Must be generally healthy
* Must have eaten nuts within the last month with no adverse effects

Exclusion Criteria:

* Must not be allergic to nuts of any kind
* Must not have any teeth missing (apart from unerupted wisdom teeth)
* Must not have bleeding gums
* Must not have had dental treatment (other than checkups) in the last 3 months
* Must not be currently suffering from any infectious disease that may be passed on via saliva e.g. Glandular fever, flu

Primary outcomes:
measure: Particle size distribution of masticated nuts
timeFrame: At time of expectoration, up to 90 seconds after each sample ingested
Secondary outcomes:
measure: Lipid content of masticated nuts
timeFrame: At time of expectoration, up to 90 seconds after each sample ingested.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Diabetes and Nutritional Sciences Division, School of Medicine, King's College London
Study officials:
affiliation: King's College London
name: Sarah EE Berry, BSc MSc PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grundy MM, Grassby T, Mandalari G, Waldron KW, Butterworth PJ, Berry SE, Ellis PR. Effect of mastication on lipid bioaccessibility of almonds in a randomized human study and its implications for digestion kinetics, metabolizable energy, and postprandial lipemia. Am J Clin Nutr. 2015 Jan;101(1):25-33. doi: 10.3945/ajcn.114.088328. Epub 2014 Nov 12.
citation: Grassby T, Picout DR, Mandalari G, Faulks RM, Kendall CW, Rich GT, Wickham MS, Lapsley K, Ellis PR. Modelling of nutrient bioaccessibility in almond seeds based on the fracture properties of their cell walls. Food Funct. 2014 Dec;5(12):3096-106. doi: 10.1039/c4fo00659c.