This trial is active, not recruiting.

Condition healthy
Treatment chewing of nuts
Sponsor King's College London
Start date June 2015
End date August 2015
Trial size 10 participants
Trial identifier NCT02497768, 15/WS/0104


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
8 samples (4-5 g) of nuts (pistachios or Brazils) on two separate visit days.
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.

Primary Outcomes

Particle size distribution of masticated nuts
time frame: At time of expectoration, up to 90 seconds after each sample ingested

Secondary Outcomes

Lipid content of masticated nuts
time frame: At time of expectoration, up to 90 seconds after each sample ingested.

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Particle Sizing of Masticated Tree Nuts - Pistachios and Brazils
Principal investigator Sarah EE Berry, BSc MSc PhD
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by King's College London.