Incorporating Avocados in Meals

Study Overview
=================
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.

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

Conditions
-----------------
Satiety, Glycemic Index, Insulin, Gastrointestinal Peptides and Hormones

Intervention / Treatment
-----------------
* Dietary Supplement: Avocado supplement
* Dietary Supplement: Avocado included


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 23 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>While on the control arm subjects will be given a meal with no avocado. | |
| Active Comparator: Avocado supplement<br>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<br>* Calories from avocados replace calories of the control lunch<br>|
| Active Comparator: Avocado included<br>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<br>* Calories from avocados will be added to calories from the control lunch<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-ingestion glycemic index | 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 | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Avocados, Satiety, Feeding study