Incorporating Avocados in Meals
This study is ongoing, but not recruiting participants.
Sponsor:
Loma Linda University
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
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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 |
| Estimated Study Completion Date: | September 2012 |
| Estimated 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
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
No publications provided
| 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: | June 19, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Loma Linda University:
|
Avocados Satiety Feeding study |
ClinicalTrials.gov processed this record on May 16, 2013