Availability of Lipids in Almonds in Healthy Individuals

November 15, 2013 updated by: Richard Mattes, Purdue University

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • West Lafayette, Indiana, United States, 47907
        • Purdue University, Laboratory forSensory and Ingestive Studies

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

University and community sample

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Crossover
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants
Participants completed all 3-arms of this cross-over design study.
Behavioral: 10 chews
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.
Other Names:
  • Almonds
Behavioral: 25 Chews
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.
Other Names:
  • Almonds
Behavioral: 40 Chews
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.
Other Names:
  • Almonds

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lipid available for absorption as measured by stool collections, appetite measures, blood analysis
Time Frame: 3, 4 day periods
3, 4 day periods

Secondary Outcome Measures

Outcome Measure
Time Frame
Particle size distribution as measured by mechanical sieving process
Time Frame: 3 separate sessions
3 separate sessions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Purdue University

Collaborators

Almond Board of California

Investigators

  • Principal Investigator: Richard D Mattes, MPH, PhD, RD, Purdue University
  • Study Director: Bridget A Cassady, B.S., Purdue University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

October 7, 2008

First Submitted That Met QC Criteria

October 7, 2008

First Posted (Estimate)

October 8, 2008

Study Record Updates

Last Update Posted (Estimate)

November 18, 2013

Last Update Submitted That Met QC Criteria

November 15, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0511003189

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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