Particle Sizing of Masticated Tree Nuts - Pistachios and Brazils

Healthy Clinical Trial

Official title:

Particle Sizing of Masticated Tree Nuts - Pistachios and Brazils

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02497768
• Other study ID #: 15/WS/0104
• Status: Active, not recruiting
• Phase: N/A
• First received: July 7, 2015
• Last updated: March 8, 2016
• Start date: June 2015
• Est. completion date: April 2016

Study information

• Verified date: March 2016
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: April 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Chewing of nuts
The volunteers will be asked to chew and spit 8 portions (4-5 g) of nuts (pistachios or Brazils) on two separate visits. They will provide samples for particle sizing. Two portions will be used as practice samples in order to measure the number of chews. Two portions will be sieved. Two portions will be measured by laser diffraction. Two portions will be frozen for later lipid analysis.

Locations

Country	Name	City	State
United Kingdom	Diabetes and Nutritional Sciences Division, School of Medicine, King's College London	London

Sponsors (1)

Lead Sponsor	Collaborator
King's College London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Particle size distribution of masticated nuts	Particle size distribution of masticated nuts as measured by laser diffraction and sieving.	At time of expectoration, up to 90 seconds after each sample ingested	No
Secondary	Lipid content of masticated nuts	Lipid content of masticated nuts as measured by Soxhlet to be compared to predictions form mathematical model.	At time of expectoration, up to 90 seconds after each sample ingested.	No