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Availability of Lipids in Almonds in Healthy Individuals

This study has been completed.
Sponsor:
Collaborator:
Almond Board of California
Information provided by (Responsible Party):
Richard Mattes, Purdue University
ClinicalTrials.gov Identifier:
NCT00768417
First received: October 7, 2008
Last updated: November 15, 2013
Last verified: November 2013
  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.


Condition Intervention
Obesity
Overweight
Behavioral: 10 chews
Behavioral: 25 Chews
Behavioral: 40 Chews

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Official Title: Mastication of Almonds: Effects of Lipid Bioaccessibility, Appetite, and Hormone Response

Further study details as provided by Purdue University:

Primary Outcome Measures:
  • Lipid available for absorption as measured by stool collections, appetite measures, blood analysis [ Time Frame: 3, 4 day periods ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Particle size distribution as measured by mechanical sieving process [ Time Frame: 3 separate sessions ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Plasma, feces


Enrollment: 20
Study Start Date: April 2006
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: 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 Name: 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 Name: Almonds

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

University and community sample

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00768417

Locations
United States, Indiana
Purdue University, Laboratory forSensory and Ingestive Studies
West Lafayette, Indiana, United States, 47907
Sponsors and Collaborators
Purdue University
Almond Board of California
Investigators
Principal Investigator: Richard D Mattes, MPH, PhD, RD Purdue University
Study Director: Bridget A Cassady, B.S. Purdue University
  More Information

No publications provided by Purdue University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Richard Mattes, Distinguished Professor, Foods and Nutrition, Purdue University
ClinicalTrials.gov Identifier: NCT00768417     History of Changes
Other Study ID Numbers: 0511003189
Study First Received: October 7, 2008
Last Updated: November 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Purdue University:
Nuts
Lipids
Mastication
Bioaccessibility
Satiety
Hormones
Human

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014