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OpenTrials
Completed

NCT Number: NCT00768417

Availability of Lipids in Almonds in Healthy Individuals

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Purdue University, Laboratory forSensory and Ingestive Studies

West Lafayette, Indiana, 47907, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

10 chews

Behavioral

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

25 Chews

Behavioral

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

40 Chews

Behavioral

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

Primary outcomes

  1. Lipid available for absorption as measured by stool collections, appetite measures, blood analysis

    Time frame: 3, 4 day periods

Secondary outcomes

  1. Particle size distribution as measured by mechanical sieving process

    Time frame: 3 separate sessions

Sponsors and collaborators

Lead sponsor

Purdue University

Other

Collaborators

  • Almond Board of California

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Oct 8, 2008
Registry last updated
Nov 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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