Incorporating Avocados in Meals

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

Hass Avocado Board

Information provided by (Responsible Party):

Joan Sabate,DrPH, MD, Loma Linda University

ClinicalTrials.gov Identifier:

NCT01271829

First received: January 5, 2011

Last updated: June 19, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

January 5, 2011

Last Updated Date

June 19, 2012

Start Date ^ICMJE

January 2011

Estimated Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Satiety [ Time Frame: 12 hours ] [ Designated as safety issue: No ]

The effect that consumption of avocados has on feelings of fullness and the quantity of food consumed in a subsequent eating episode

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01271829 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

post-ingestion glycemic index [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
Blood will be drawn at 30 minutes, 60 minutes, 120 minutes and 180 minutes after consumption of a meal with or without avocados. The glycemic index will be analyzed.
insulin response [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
Blood will be drawn at 30 minutes, 60 minutes, 120 minutes and 180 minutes after consumption of a meal with or without avocados. Insulin response will be analyzed.
appetite-related gastrointestinal peptide and hormone release [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
Blood will be drawn at 30 minutes, 60 minutes, 120 minutes and 180 minutes after consumption of a meal with or without avocados. Gastrointestinal peptide and hormones will be analyzed.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Incorporating Avocados in Meals

Official Title ^ICMJE

Incorporating Avocados in Meals: Effect on Glycemic Index, Insulin Response, Satiety and Satiety-related Gastrointestinal Peptides in Humans

Brief Summary

The purpose of this study is to examine the effect of incorporating avocados in meals on post-ingestion glycemic index, insulin response, sensations of satiety and on appetite-related gastrointestinal peptide and hormone release. Also the effect of consuming avocado containing meals on the caloric intake of participants in subsequent eating episodes will be explored.

Each subject will participate in one intervention for one day, wait one or two weeks, come for another intervention, wait one or two weeks and come for a final intervention- three in total. Participants will be randomly assigned to one of six treatment sequences. Postprandial response to the control and two avocado-containing test meals will be assessed and compared using a 3 x 3 single blind cross-over design. The Subjects will be between 25 and 60 years old, female or male, with a BMI of 23 to 32, stable weight, no sports involvement, non-smoking and not dependent on caffeine. Thirty subjects will be recruited.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)

Condition ^ICMJE

Satiety
Glycemic Index
Insulin
Gastrointestinal Peptides and Hormones

Intervention ^ICMJE

Dietary Supplement: Avocado supplement
Calories from avocados replace calories of the control lunch
Dietary Supplement: Avocado included
Calories from avocados will be added to calories from the control lunch

Study Arm (s)

No Intervention: Control
While on the control arm subjects will be given a meal with no avocado.
Active Comparator: Avocado supplement
While on the avocado supplement arm subjects will be given a meal in which a given amount of calories will be replaced by calories contributed by avocados.

Intervention: Dietary Supplement: Avocado supplement
Active Comparator: Avocado included
While on the avocado included arm subjects will be given a meal in which the calories of avocado will be added to the calories of the control meal.

Intervention: Dietary Supplement: Avocado included

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

September 2012

Estimated Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

23-60 years old
BMI 23-32
Stable weight for 6 months
Live or work near Loma Linda University

Exclusion Criteria:

Smoker
Heavy involvement in sports
Dependent on caffeine

Gender

Both

Ages

23 Years to 60 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01271829

Other Study ID Numbers ^ICMJE

5100220

Has Data Monitoring Committee

Yes

Responsible Party

Joan Sabate,DrPH, MD, Loma Linda University

Study Sponsor ^ICMJE

Loma Linda University

Collaborators ^ICMJE

Hass Avocado Board

Investigators ^ICMJE

Principal Investigator:

Joan Sabaté, MD, DrPH

Loma Linda University

Information Provided By

Loma Linda University

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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