Incorporating Avocados in Meals

This study has been completed.
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: March 17, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Satiety
Glycemic Index
Insulin
Gastrointestinal Peptides and Hormones
Dietary Supplement: Avocado supplement
Dietary Supplement: Avocado included

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Official Title: Incorporating Avocados in Meals: Effect on Glycemic Index, Insulin Response, Satiety and Satiety-related Gastrointestinal Peptides in Humans

Resource links provided by NLM:


Further study details as provided by Loma Linda University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 30
Study Start Date: January 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Dietary Supplement: Avocado supplement
Calories from avocados replace calories of the control lunch
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.
Dietary Supplement: Avocado included
Calories from avocados will be added to calories from the control lunch

  Eligibility

Ages Eligible for Study:   23 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01271829

Locations
United States, California
Loma Linda University, Department of Nutrition
Loma Linda, California, United States, 92350
Sponsors and Collaborators
Loma Linda University
Hass Avocado Board
Investigators
Principal Investigator: Joan Sabaté, MD, DrPH Loma Linda University
  More Information

Additional Information:
Publications:
Responsible Party: Joan Sabate,DrPH, MD, Chair, Department of Nutrition, Loma Linda University
ClinicalTrials.gov Identifier: NCT01271829     History of Changes
Other Study ID Numbers: 5100220
Study First Received: January 5, 2011
Last Updated: March 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Loma Linda University:
Avocados
Satiety
Feeding study

ClinicalTrials.gov processed this record on July 23, 2014