NCT01271829

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

March 18, 2014

Status Verified

March 1, 2014

Enrollment Period

1.7 years

First QC Date

January 5, 2011

Last Update Submit

March 17, 2014

Conditions

SatietyGlycemic IndexInsulinGastrointestinal Peptides and Hormones

Keywords

AvocadosSatietyFeeding study

Outcome Measures

Primary Outcomes (1)

  • Satiety

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

    12 hours

Secondary Outcomes (3)

  • post-ingestion glycemic index

    3 hours

  • insulin response

    3 hours

  • appetite-related gastrointestinal peptide and hormone release

    3 hours

Study Arms (3)

Control

NO INTERVENTION

While on the control arm subjects will be given a meal with no avocado.

Avocado supplement

ACTIVE COMPARATOR

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.

Dietary Supplement: Avocado supplement

Avocado included

ACTIVE COMPARATOR

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.

Dietary Supplement: Avocado included

Interventions

Avocado supplementDIETARY_SUPPLEMENT

Calories from avocados replace calories of the control lunch

Avocado supplement
Avocado includedDIETARY_SUPPLEMENT

Calories from avocados will be added to calories from the control lunch

Avocado included

Eligibility Criteria

Age23 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Smoker
  • Heavy involvement in sports
  • Dependent on caffeine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda University, Department of Nutrition

Loma Linda, California, 92350, United States

Location

Related Publications (1)

  • Wien M, Haddad E, Oda K, Sabate J. A randomized 3x3 crossover study to evaluate the effect of Hass avocado intake on post-ingestive satiety, glucose and insulin levels, and subsequent energy intake in overweight adults. Nutr J. 2013 Nov 27;12:155. doi: 10.1186/1475-2891-12-155.

    PMID: 24279738RESULT

Related Links

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Joan Sabaté, MD, DrPH

    Loma Linda University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair, Department of Nutrition

Study Record Dates

First Submitted

January 5, 2011

First Posted

January 7, 2011

Study Start

January 1, 2011

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

March 18, 2014

Record last verified: 2014-03

Locations

US(1)