NCT02927028

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2016

Completed
6 months until next milestone

First Posted

Study publicly available on registry

October 6, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2016

Completed
Last Updated

December 12, 2023

Status Verified

December 1, 2023

Enrollment Period

8 months

First QC Date

October 14, 2015

Last Update Submit

December 11, 2023

Conditions

Keywords

energy availabilitywalnuts

Outcome Measures

Primary Outcomes (1)

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

    Released fat concentration following chewing.

    7 months

Secondary Outcomes (1)

  • Particle size disruption

    7 months

Other Outcomes (8)

  • Cell staining and counting

    7 months

  • Appetite ratings

    7 months

  • In vitro digestion

    7 months

  • +5 more other outcomes

Study Arms (1)

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.

Other: Chewing

Interventions

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.

Chewing group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Natural dentition and no oral pathology
  • Rate hedonic value of all study foods between 3 and 7 on a 9-point category scale.

You may not qualify if:

  • BMI between 18-35 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47906, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Mastication

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EatingNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaDigestive System Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Richard D Mattes, PhD

    Purdue University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished Professor

Study Record Dates

First Submitted

October 14, 2015

First Posted

October 6, 2016

Study Start

August 1, 2015

Primary Completion

March 30, 2016

Study Completion

December 30, 2016

Last Updated

December 12, 2023

Record last verified: 2023-12

Locations