Availability of Lipids in Almonds in Healthy Individuals | NCT00768417

Studies
Availability of Lipids in Almonds in Healthy Individuals

NCT00768417

Sponsor

Purdue University

Status

Completed

Last Update Posted

Nov 18, 2013Estimated

Enrollment

20Actual

Phase

Not provided

Conditions

Obesity
Overweight

Interventions

10 chews
25 Chews
40 Chews

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2006

Primary Completion Date

Aug 2007Actual

Completion Date

Aug 2007Actual

First Submitted Date

Oct 7, 2008

First Submission Date that Met QC Criteria

Oct 7, 2008

First Posted Date

Oct 8, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 15, 2013

Last Update Posted Date

Nov 18, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Richard Mattes, Distinguished Professor, Foods and Nutrition, Purdue UniversityPrincipal Investigator

Lead Sponsor

Purdue UniversityOTHER

Collaborators

Name	Class
Almond Board of California	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Participants		Participants completed all 3-arms of this cross-over design study.	Behavioral: 10 chews Behavioral: 25 Chews Behavioral: 40 Chews

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Lipid available for absorption as measured by stool collections, appetite measures, blood analysis		3, 4 day periods

Secondary Outcomes

Measure	Description	Time Frame
Particle size distribution as measured by mechanical sieving process		3 separate sessions

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

University and community sample

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Richard D Mattes, MPH, PhD, RD	Purdue University	Principal Investigator
Bridget A Cassady, B.S.	Purdue University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Purdue University, Laboratory forSensory and Ingestive Studies		West Lafayette	Indiana	47907	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19144727	Derived	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.

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight

ID	Term
D009765	Obesity
D050177	Overweight