- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01271829
Incorporating Avocados in Meals
Incorporating Avocados in Meals: Effect on Glycemic Index, Insulin Response, Satiety and Satiety-related Gastrointestinal Peptides in Humans
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Loma Linda, California, United States, 92350
- Loma Linda University, Department of Nutrition
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
Calories from avocados will be added to calories from the control lunch
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Satiety
Time Frame: 12 hours
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
post-ingestion glycemic index
Time Frame: 3 hours
|
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.
|
3 hours
|
|
insulin response
Time Frame: 3 hours
|
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.
|
3 hours
|
|
appetite-related gastrointestinal peptide and hormone release
Time Frame: 3 hours
|
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.
|
3 hours
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Joan Sabaté, MD, DrPH, Loma Linda University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 5100220
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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