HealthyNCT02398084
Particle Sizing of Masticated Tree Nuts - Cashews and Walnuts
A study testing Chewing of nuts in people with Healthy, run by King's College London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Chewing of nuts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be generally healthy
- Must have eaten nuts within the last month with no adverse effects
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Diabetes and Nutritional Sciences Division, School of Medicine, King's College London
London, SE1 9NH
About this study
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:
Read more
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.
- Conditions
- Healthy
- Being tested
- Chewing of nuts
- Keywords
- mastication, cashews, walnuts, participants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chewing of nutsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Chewing of nuts | Experimental | 8 samples (4-5 g) of nuts (cashews or walnuts) on two separate visit days. Receives: Other: Chewing of nuts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Particle size distribution of masticated nuts
Particle size distribution of masticated nuts as measured by laser diffraction and sieving.
Measured: At time of expectoration, up to 90 seconds after each sample ingested.
Secondary outcomes (1)
Lipid content of masticated nuts
Lipid content of masticated nuts as measured by Soxhlet to be compared to predictions form mathematical model.
Measured: At time of expectoration, up to 90 seconds after each sample ingested.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionApr 2015
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Terri Grassby, BSc PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02398084
- Sponsor's protocol ID
- 14/LO/2286
- Status last verified
- Mar 2016
- First submitted
- 11 Mar 2015
- Last updated
- 9 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 25527747Grassby 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.
PubMed 25310222
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Particle Sizing of Masticated Tree Nuts - Cashews and Walnuts
- ClinicalTrials.gov ID
- NCT02398084
- Acronym / sponsor ID
- 14/LO/2286
- Conditions
- Healthy
- Keywords
- mastication, cashews, walnuts, participants
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2016 (estimated)
- First posted
- 25 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chewing of nuts | Experimental | Other: Chewing of nuts8 samples (4-5 g) of nuts (cashews or walnuts) on two separate visit days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Must be generally healthy
- Must have eaten nuts within the last month with no adverse effects
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chewing of nutsThe 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. | Other | Chewing of nuts |
Primary outcome
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.
1 secondary outcome
Lipid content of masticated nuts
Time frame: At time of expectoration, up to 90 seconds after each sample ingested.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2016.
- Background: PubMed 25527747Grundy 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.
- Background: PubMed 25310222Grassby 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terri Grassby, BSc PhD principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chewing of nuts in people with Healthy, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Particle size distribution of masticated nuts (time frame: At time of expectoration, up to 90 seconds after each sample ingested.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02398084, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2016.