Availability of Lipids in Almonds in Healthy Individuals

Completed

• Conditions: Obesity; Overweight
• Interventions: Behavioral: 10 chews; Behavioral: 25 Chews; Behavioral: 40 Chews

• Registration Number: NCT00768417
• Lead Sponsor: Purdue University

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.

Study Timeline

• Study Start: 2006-04
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Study First Submitted: 2008-10-07
• Study First Submitted QC: 2008-10-07
• Study First Posted: 2008-10-08
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-15
• Last Update Posted: 2013-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants	10 chews	Participants completed all 3-arms of this cross-over design study.
Participants	25 Chews	Participants completed all 3-arms of this cross-over design study.
Participants	40 Chews	Participants completed all 3-arms of this cross-over design study.

Primary Outcome Measures

Name	Time	Method
Lipid available for absorption as measured by stool collections, appetite measures, blood analysis	3, 4 day periods

Secondary Outcome Measures

Name	Time	Method
Particle size distribution as measured by mechanical sieving process	3 separate sessions

Trial Locations

Locations (1)

Purdue University, Laboratory forSensory and Ingestive Studies; 🇺🇸 West Lafayette, Indiana, United States