Availability of Lipids in Almonds in Healthy Individuals

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00768417
• Other study ID #: 0511003189
• Status: Completed
• Phase: N/A
• First received: October 7, 2008
• Last updated: November 15, 2013
• Start date: April 2006
• Est. completion date: August 2007

Study information

• Verified date: November 2013
• Source: Purdue University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Observational Model: Case-Crossover, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Purdue University, Laboratory forSensory and Ingestive Studies	West Lafayette	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Purdue University	Almond Board of California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lipid available for absorption as measured by stool collections, appetite measures, blood analysis		3, 4 day periods	No
Secondary	Particle size distribution as measured by mechanical sieving process		3 separate sessions	No