NCT02398084

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 11, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 25, 2015

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

March 9, 2016

Status Verified

March 1, 2016

Enrollment Period

2 months

First QC Date

March 11, 2015

Last Update Submit

March 8, 2016

Conditions

Healthy

Keywords

masticationcashewswalnutsparticipants

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (1)

  • Lipid content of masticated nuts

    At time of expectoration, up to 90 seconds after each sample ingested.

Study Arms (1)

Chewing of nuts

EXPERIMENTAL

8 samples (4-5 g) of nuts (cashews or walnuts) on two separate visit days.

Other: Chewing of nuts

Interventions

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.

Chewing of nuts

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must be generally healthy
  • Must have eaten nuts within the last month with no adverse effects

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diabetes and Nutritional Sciences Division, School of Medicine, King's College London

London, SE1 9NH, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 25527747BACKGROUND

  • 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.

    PMID: 25310222BACKGROUND

Study Officials

  • Terri Grassby, BSc PhD

    King's College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2015

First Posted

March 25, 2015

Study Start

February 1, 2015

Primary Completion

April 1, 2015

Study Completion

April 1, 2016

Last Updated

March 9, 2016

Record last verified: 2016-03

Locations

GB(1)