- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02398084
Particle Sizing of Masticated Tree Nuts - Cashews and Walnuts
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
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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London, United Kingdom, SE1 9NH
- Diabetes and Nutritional Sciences Division, School of Medicine, King's College London
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 (cashews or walnuts) on two separate visit days.
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The volunteers will be asked to chew and spit 8 portions (4-5 g) of nuts (cashews or walnuts) 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.
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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.
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Particle size distribution of masticated nuts as measured by laser diffraction and sieving.
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At time of expectoration, up to 90 seconds after each sample ingested.
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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.
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Lipid content of masticated nuts as measured by Soxhlet to be compared to predictions form mathematical model.
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At time of expectoration, up to 90 seconds after each sample ingested.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Terri Grassby, BSc PhD, King's College London
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 14/LO/2286
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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