Expired Study
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West Lafayette, Indiana 47907


Purpose:

Evidence indicates that almond consumption is associated with multiple health benefits. However, nuts are commonly excluded from diets on the basis that their high energy content may induce weight gain. Evidence from numerous studies show that this is not the case, yet the mechanism responsible for the less than predicted effect on weight is unknown. This study aimed to examine the effects of increased mastication on lipid bioavailability and satiety related peptide released in humans. Its purpose is to provide valuable mechanistic data to support the results from previous completed clinical studies.


Study summary:

This cross-over study consisted of three study periods of four consecutive days separated by at least one week. During each day of the three study periods, participants were required to consume 55g of almonds split up into 5 g portions. They were required to chew the almonds 10, 25, or 40 times before swallowing, depending on the treatment. During each treatment period, all participants followed the same procedures over the four days. On day one after an overnight fast, participants reported to the laboratory and were presented with 11, 5 gram portions of almonds to chew 10, 25, or 40 times, depending on treatment arm. The participant remained in the laboratory for 4 hours post-almond consumption for measurements of blood and appetite. For the remainder of the 4 days, participants consumed all meals in the laboratory and collected all stools passed. On a separate occasion, recovered particle sizes of masticated almonds were measured by a mechanical sieving process. Individuals chewed almond samples either 10, 25 or 40 times and expectorated them into sieves.


Criteria:

Inclusion Criteria: - 18-50 years of age - BMI 20-25 kg/m2 - Full set of healthy teeth - Weight stable (<3 kg change in past 3 mo) Exclusion Criteria: - Smoker - Eating Disorders or high level of restraint - Endocrine disorders - Pregnant or lactating - Allergic to nuts - Taking medication likely to confound study outcomes (meds affecting appetite)


Study is Available At:


Original ID:

0511003189


NCT ID:

NCT00768417


Secondary ID:


Study Acronym:


Brief Title:

Availability of Lipids in Almonds in Healthy Individuals


Official Title:

Mastication of Almonds: Effects of Lipid Bioaccessibility, Appetite, and Hormone Response


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

50 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Purdue University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Case-Crossover, Time Perspect


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

20


Enrollment Type:

Actual


Overall Contact Information

Official Name:Richard D Mattes, MPH, PhD, RD
Principal Investigator
Purdue University

Study Dates

Start Date:April 2006
Completion Date:August 2007
Completion Type:Actual
Primary Completion Date:August 2007
Primary Completion Type:Actual
Verification Date:November 2013
Last Changed Date:November 15, 2013
First Received Date:October 7, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Particle size distribution as measured by mechanical sieving process
Time Frame:3 separate sessions
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Lipid available for absorption as measured by stool collections, appetite measures, blood analysis
Time Frame:3, 4 day periods
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:10 chews
Description:Participants were required to chew 55g grams of almonds per day for four days in 11, 5 gram portions. Almonds were to be chewed 10 times before swallowing.
Arm Name:Participants
Other Name:Almonds
Intervention Type:Behavioral
Name:25 Chews
Description:Participants were required to chew 55g grams of almonds per day for four days in 11, 5 gram portions. Almonds were to be chewed 25 times before swallowing.
Arm Name:Participants
Other Name:Almonds
Intervention Type:Behavioral
Name:40 Chews
Description:Participants were required to chew 55g grams of almonds per day for four days in 11, 5 gram portions. Almonds were to be chewed 40 times before swallowing.
Arm Name:Participants
Other Name:Almonds

Study Arms

Study Arm Type:Other
Arm Name:Participants
Description:Participants completed all 3-arms of this cross-over design study.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Purdue University
Agency Class:Other
Agency Type:Collaborator
Agency Name:Almond Board of California

Samples and Retentions

Sample Retention:Samples With DNA
Description: Plasma, feces
Study Population: University and community sample
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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