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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

United States1 site
  • Purdue University

    West Lafayette, Indiana, 47906

Other trials in United States

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 groups in NCT02927028
Study groupRoleWhat they receive
Chewing groupOther50 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.

  1. Effects of oral processing on the energy yield from walnuts.

    Released fat concentration following chewing.

    Measured: 7 months

Secondary outcomes (1)
  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.

  1. First posted6 Oct 2016 (estimated)
  2. Study start1 Aug 2015
  3. Primary completion30 Mar 2016
  4. Study completion30 Dec 2016

Resources

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)
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

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.

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