Clinical trial NCT00768417: Availability of Lipids in Almonds in Healthy Individuals
Official title: Mastication of Almonds: Effects of Lipid Bioaccessibility, Appetite, and Hormone Response
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Overweight
Keywords: Nuts
Lipids
Mastication
Bioaccessibility
Satiety
Hormones
Human
Lead sponsor: Purdue University
Sponsor class: OTHER
Collaborators: name: Almond Board of California
First posted: 2008-10-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: University and community sample

Brief summary: 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.

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 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)

Primary outcomes:
measure: Lipid available for absorption as measured by stool collections, appetite measures, blood analysis
timeFrame: 3, 4 day periods
Secondary outcomes:
measure: Particle size distribution as measured by mechanical sieving process
timeFrame: 3 separate sessions
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University, Laboratory forSensory and Ingestive Studies
state: Indiana
Study officials:
affiliation: Purdue University
name: Richard D Mattes, MPH, PhD, RD
role: PRINCIPAL_INVESTIGATOR
affiliation: Purdue University
name: Bridget A Cassady, B.S.
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.3945/ajcn.2008.26669. Epub 2009 Jan 14.