Particle Sizing of Masticated Tree Nuts - Pistachios and Brazils

March 8, 2016 updated by: King's College London

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SE1 9NH
        • Diabetes and Nutritional Sciences Division, School of Medicine, King's College London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chewing of nuts
8 samples (4-5 g) of nuts (pistachios or Brazils) on two separate visit days.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Particle size distribution of masticated nuts
Time Frame: At time of expectoration, up to 90 seconds after each sample ingested
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lipid content of masticated nuts
Time Frame: At time of expectoration, up to 90 seconds after each sample ingested.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College London

Investigators

  • Principal Investigator: Sarah EE Berry, BSc MSc PhD, King's College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

August 1, 2015

Study Completion (Anticipated)

April 1, 2016

Study Registration Dates

First Submitted

July 7, 2015

First Submitted That Met QC Criteria

July 14, 2015

First Posted (Estimate)

July 15, 2015

Study Record Updates

Last Update Posted (Estimate)

March 9, 2016

Last Update Submitted That Met QC Criteria

March 8, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 15/WS/0104

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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