World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 13 January 2015
Main ID:  ISRCTN58438021
Date of registration: 13/11/2013
Prospective Registration: No
Primary sponsor: King's College London (UK)
Public title: Characterisation of chewed/sucked and expectorated raw almonds
Scientific title: The role of plant cell walls in regulating starch and lipid bioaccessibility from plant foods: in silico, in vivo and in vitro studies
Date of first enrolment: 15/04/2011
Target sample size: 15
Recruitment status: Completed
URL:  http://isrctn.com/ISRCTN58438021
Study type:  Interventional
Study design:  Randomised cross-over design trial (Other)  
Phase: 
Countries of recruitment
United Kingdom
Contacts
Name: Peter    Ellis
Address:  King's College London Biopolymers Group Department of Biochemistry Diabetes & Nutritional Sciences Division Franklin-Wilkins Building SE1 9NH London United Kingdom
Telephone:
Email:
Affiliation: 
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: 1. Be generally healthy
2. Healthy dentition
3. Be at least 18 years old
4. Have eaten almonds with no adverse effects

Exclusion criteria: You must not:
1. Be allergic to nuts of any kind
2. Be allergic to celery, pears, apples, cherries, peaches or parsley
3. Have any teeth missing (apart from unerupted wisdom teeth)
4. Have bleeding gums
5. Had dental treatment (other than checkups) in the last 3 months
6. Be currently suffering from any infectious disease that may be passed on via saliva e.g. Glandular fever, flu
7. Be allergic to wheat, gluten or milk, if chewing the almond muffin meals


Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
Digestion and nutrient bioaccessibility
Nutritional, Metabolic, Endocrine
Intervention(s)
Volunteers are randomly allocated to treatments using an electronic randomisation program

1. Mastication and expectoration of whole raw and roasted almonds.
2. Mastication and expectoration of muffins containing almond flour or almond particles of 2 mm.
Primary Outcome(s)
Measure the size of almond particles that have been chewed sufficiently to be swallowed. Mechanical sieving and laser diffraction are used to measure particle size distribution of the expectorated and digested almonds.
Secondary Outcome(s)
1. Find shape parameters (numerical values) that describe the general particle shape to allow the theoretical model to predict lipid release from intact cells: examined by microscopy (light, scanning electron and transmission)
2. Measure any changes in lipid content and cell-wall polysaccharide composition due to chewing. Quantifying the amount of lipid lost using the Soxhlet method and cell wall changes by gas chromatography.
3. Determine whether cooking almonds affects the release of lipid from the chewed almonds: examined by microscopy (light, scanning electron and transmission)
4. Determine whether lipid is removed from ruptured cells only when in the presence of saliva: examined by microscopy (light, scanning electron and transmission)
5. Determine the effects of chewing on lipid release and cell-wall structure during simulated gastric (stomach) digestion. Quantifying the amount of lipid lost using the Soxhlet method and cell wall changes by gas chromatography.
6. Evaluate how almond incorporated into a complex food structure (muffin) behaves following chewing and simulated digestion. Quantifying the amount of lipid lost using the Soxhlet method and cell wall changes by gas chromatography.

Time points:
1. Baseline (analysis of raw and roasted almonds, and muffins)
2. After mastication
3. During/after gastric digestion (various time points depending on the test food, i.e. almond vs muffin)
4. After duodenal digestion

Chewed almond and muffins are loaded into an in vitro digestion model (Dynamic Gastric Model at the Institute of Food Research in Norwich)
Secondary ID(s)
N/A
Source(s) of Monetary Support
Biotechnology and Biological Sciences Research Council (BBSRC) (UK), reference BB/H004866/1
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history