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

October 7, 2008
November 15, 2013
April 2006
August 2007   (final data collection date for primary outcome measure)
Lipid available for absorption as measured by stool collections, appetite measures, blood analysis [ Time Frame: 3, 4 day periods ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00768417 on ClinicalTrials.gov Archive Site
Particle size distribution as measured by mechanical sieving process [ Time Frame: 3 separate sessions ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Availability of Lipids in Almonds in Healthy Individuals
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.

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.

Observational
Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

Plasma, feces

Non-Probability Sample

University and community sample

  • Obesity
  • Overweight
  • 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
Participants
Participants completed all 3-arms of this cross-over design study.
Interventions:
  • Behavioral: 10 chews
  • Behavioral: 25 Chews
  • Behavioral: 40 Chews
Cassady BA, Hollis JH, Fulford AD, Considine RV, Mattes RD. Mastication of almonds: effects of lipid bioaccessibility, appetite, and hormone response. Am J Clin Nutr. 2009 Mar;89(3):794-800. Epub 2009 Jan 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
August 2007
August 2007   (final data collection date for primary outcome measure)

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)
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00768417
0511003189
Yes
Richard Mattes, Purdue University
Purdue University
Almond Board of California
Principal Investigator: Richard D Mattes, MPH, PhD, RD Purdue University
Study Director: Bridget A Cassady, B.S. Purdue University
Purdue University
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP