- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02927028
The Effects of Mastication on Energy Release From Walnuts
The Effects of Mastication and Digestion on the Bio Accessibility of Energy From Walnuts
Study Overview
Detailed Description
Recent evidence indicates up to 20% of the energy from walnuts is not absorbed. This low bio accessibility is comparable to almonds with markedly different physical properties and much higher than for pistachios with similar physical characteristics. These counter-intuitive findings require mechanistic explanations so they may be accepted and used to formulate policy and clinical recommendations. It is proposed that the differences in the structure of nuts accounts for the energy yield results. In addition, the whole nut yields superior effects on fullness and this leads to focus on oral processing. It may be that the mechanical act of chewing generates satiety sensations or it may be that the mechanical disruption of the parenchymal call walls releases lipid and protein and their higher concentrations activate the release of gut peptides associated with satiety.
Visit 1: Participants will report the Laboratory of Sensory and Ingestive Studies following and overnight fast, and having refrained from using oral care products for at least two hours prior to the visit. Participants who meet the BMI requirements, will have electrodes placed on their wrist, upper, and lower jaw and will be asked to chew the following stimuli: walnuts, almonds and pistachios for 15 seconds and expectorate the bolus into a beaker. However, when presented with 5 g walnuts participants will be asked to chew until the point where they would normally swallow and then spit the bolus into a beaker. The chewing conditions are randomized and include: 1) 5 g nuts alone, 2) 5 g nuts with 5 ml water, 3) 5 g nuts with 5 ml apple juice, 4) 5 g nuts with 5 g plain yogurt, 5) 5 g nuts with 5 g sweet yogurt. Following each chewing condition, participants will rate hedonic preference on a 9-point scale.
Visit 2 and 3: Following an overnight fast, the participant will be placed in a semi-supine position and a catheter will be placed in a vein in the antecubital space of one arm. A 9 ml baseline blood sample will be collected. Participants will complete a validated appetite questionnaire on a palm pilot right after the baseline blood draw. The participants will then consume 28 g of walnuts or 28 g walnut butter given in random order. Additional blood samples and appetite questionnaire will be taken at 15, 30, 45, 60,120, and 180 minutes. The blood will be stored in a minus 80 freezer to be analyzed at a later date for insulin, glucose, GLP-1, Ghrelin, and PYY.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Indiana
-
West Lafayette, Indiana, United States, 47906
- Purdue University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Natural dentition and no oral pathology
- Rate hedonic value of all study foods between 3 and 7 on a 9-point category scale.
Exclusion Criteria:
- BMI between 18-35 kg/m2
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Chewing group
50 individuals, both male and female, between the ages of 18 and 60 years old, with a BMI between 18-35 kg/m2 from any ethnic/racial background will be recruited.
Participants must have natural dentition and rate the hedonic value of all study foods between 3 and 7 on a 9-point category scale.
|
On the first visit, the random nut treatments will include chewing walnuts, almonds and pistachios. The chewing conditions will include: 1) 5 g nuts alone, 2) 5 g nuts with 5 ml water, 3) 5 g nuts with 5 ml apple juice, 4) 5 g nuts with 5 g plain yogurt, 5) 5 g nuts with 5 g sweet yogurt. On visits 2 and 3 the treatments of either 28 g of walnuts or walnut butter will be presented. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effects of oral processing on the energy yield from walnuts.
Time Frame: 7 months
|
Released fat concentration following chewing.
|
7 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Particle size disruption
Time Frame: 7 months
|
The proportion of particle size distributions of chewed samples (nuts) will be determined by sieving the boluses.
|
7 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cell staining and counting
Time Frame: 7 months
|
Quantify the effects of mastication on nut cell structure by quantify cell viability measured by cell size and number.
|
7 months
|
Appetite ratings
Time Frame: 7 months
|
The effects of walnut consumption on fullness sensations will be measured using 100 mm visual analogue scale.
Participants will rate their fullness after consuming 28 g of walnuts in two forms.
|
7 months
|
In vitro digestion
Time Frame: 7 months
|
Released fat concentration following gastric and intestinal digestion.
|
7 months
|
Insulin
Time Frame: 7 months
|
Blood samples will be taken an analyzed for insulin.
|
7 months
|
Glucose
Time Frame: 7 months
|
Blood samples will be taken an analyzed for glucose.
|
7 months
|
GLP-1
Time Frame: 7 months
|
Blood samples will be taken an analyzed for GLP-1.
|
7 months
|
Ghrelin
Time Frame: 7 months
|
Blood samples will be taken an analyzed for Ghrelin.
|
7 months
|
PYY
Time Frame: 7 months
|
Blood samples will be taken an analyzed for PYY.
|
7 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Richard D Mattes, PhD, Purdue University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 055-042
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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