ObesityNCT02927028
The Effects of Mastication on Energy Release From Walnuts
A study testing Chewing in people with Obesity, run by Purdue University at 1 site in United States.
Trial summary
With an emphasis on oral processing, this study seeks to characterize the mechanisms that account for the high satiation properties of walnuts and low energy yield during digestion. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Chewing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2015to 30 Dec 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Natural dentition and no oral pathology
- Rate hedonic value of all study foods between 3 and 7 on a 9-point category scale.
Who cannot join
- BMI between 18-35 kg/m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Mastication and Digestion on the Bio Accessibility of Energy From Walnuts
With an emphasis on oral processing, this study seeks to characterize the mechanisms that account for the high satiation properties of walnuts and low energy yield during digestion.
Read the 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.
- Conditions
- Obesity
- Being tested
- Chewing
- Keywords
- energy availability, walnuts
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChewingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Chewing group | Other | 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. Receives: Other: Chewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of oral processing on the energy yield from walnuts.
Released fat concentration following chewing.
Measured: 7 months
Secondary outcomes (1)
Particle size disruption
The proportion of particle size distributions of chewed samples (nuts) will be determined by sieving the boluses.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study start1 Aug 2015
- Primary completion30 Mar 2016
- Study completion30 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Collaborators
- California Walnut Commission
- Responsible party
- Principal investigator, Richard Mattes, Purdue University
- Investigators
- Richard D Mattes, PhD, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02927028
- Sponsor's protocol ID
- 055-042
- Status last verified
- Dec 2023
- First submitted
- 14 Oct 2015
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Mastication and Digestion on the Bio Accessibility of Energy From Walnuts
- ClinicalTrials.gov ID
- NCT02927028
- Acronym / sponsor ID
- 055-042
- Conditions
- Obesity
- Keywords
- energy availability, walnuts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Collaborators
- California Walnut Commission
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 30 Mar 2016 (actual)
- Study completion
- 30 Dec 2016 (actual)
- First posted
- 6 Oct 2016 (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.
With an emphasis on oral processing, this study seeks to characterize the mechanisms that account for the high satiation properties of walnuts and low energy yield during digestion.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chewing group | Other | Other: Chewing50 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Natural dentition and no oral pathology
- Rate hedonic value of all study foods between 3 and 7 on a 9-point category scale.
Key exclusion criteria (1 listed)
- BMI between 18-35 kg/m2
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 |
|---|---|---|
| ChewingOn 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. | Other | Chewing group |
Primary outcome
Effects of oral processing on the energy yield from walnuts.
Time frame: 7 months
Released fat concentration following chewing.
1 secondary outcome
Particle size disruption
Time frame: 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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.
Richard D Mattes, PhD principal investigator
Purdue University
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 in people with Obesity, run by Purdue University at 1 site in United States.
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 1 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: finished, as of the sponsor's last update on 12 Dec 2023. 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 States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Effects of oral processing on the energy yield from walnuts. (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Dec 2023.