SatietyNCT01271829
Incorporating Avocados in Meals
A study testing Avocado supplement and Avocado included in people with Satiety and Glycemic Index, run by Loma Linda University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 23 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Satiety, Glycemic Index, Insulin
- What is being tested?
- Avocado supplement and Avocado included
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 23-60 years old
- BMI 23-32
- Stable weight for 6 months
- Live or work near Loma Linda University
Who cannot join
- Smoker
- Heavy involvement in sports
- Dependent on caffeine
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University, Department of Nutrition
Loma Linda, California, 92350
About this study
Official title: 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.
- Being tested
- Avocado supplement, Avocado included
- Keywords
- Avocados, Satiety, Feeding study
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avocado supplementDietary supplement
Calories from avocados replace calories of the control lunch
Avocado includedDietary supplement
Calories from avocados will be added to calories from the control lunch
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Avocado included |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satiety
The effect that consumption of avocados has on feelings of fullness and the quantity of food consumed in a subsequent eating episode
Measured: 12 hours
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SatietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Collaborators
- Hass Avocado Board
- Responsible party
- Principal investigator, Joan Sabate,DrPH, MD, Loma Linda University
- Investigators
- Joan Sabaté, MD, DrPH, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01271829
- Sponsor's protocol ID
- 5100220
- Status last verified
- Mar 2014
- First submitted
- 5 Jan 2011
- Last updated
- 18 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24279738
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incorporating Avocados in Meals: Effect on Glycemic Index, Insulin Response, Satiety and Satiety-related Gastrointestinal Peptides in Humans
- ClinicalTrials.gov ID
- NCT01271829
- Acronym / sponsor ID
- 5100220
- Keywords
- Avocados, Satiety, Feeding study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Collaborators
- Hass Avocado Board
- Study start
- Jan 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 7 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –While on the control arm subjects will be given a meal with no avocado. |
| Avocado supplement | Active comparator | Dietary Supplement: Avocado supplementWhile 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. |
| Avocado included | Active comparator | Dietary Supplement: Avocado includedWhile 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. |
Who may qualify
- Ages
- 23 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 23-60 years old
- BMI 23-32
- Stable weight for 6 months
- Live or work near Loma Linda University
Key exclusion criteria (3 listed)
- Smoker
- Heavy involvement in sports
- Dependent on caffeine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Avocado supplementCalories from avocados replace calories of the control lunch | Dietary supplement | Avocado supplement |
| Avocado includedCalories from avocados will be added to calories from the control lunch | Dietary supplement | Avocado included |
Primary outcome
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
3 secondary outcomes
post-ingestion glycemic index
Time frame: 3 hours
insulin response
Time frame: 3 hours
appetite-related gastrointestinal peptide and hormone release
Time frame: 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2014.
- Results publication: PubMed 24279738Wien 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.
- Publication of study resultsLink provided by the sponsor.
Related trials for Satiety
Not yet recruitingPhase 2
Supplementation of Gut-brain Axis (GLP-1)-Activating Carbohydrates for Increasing Satiety in Adolescents With Obesity
Obesity & Overweight
Recruiting
Cerebellar TMS and Satiety in Prader-Willi Syndrome
Prader-Willi Syndrome
Recruiting
Satiety, Microbiome, Appetite Regulation, and Tracking Energy Across Targeted Snacks: Chronic Study
Healthy Participants, Healthy Adult Subject
Recruiting
Satiety, Microbiome, Appetite Regulation, and Tracking Energy Across Targeted Snacks: Acute Postprandial Study
Healthy Participants, Healthy Adult Subject
Recruiting
The Relationship Between Satiety Per Calorie (SPC) and Food Intake
Healthy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joan Sabaté, MD, DrPH principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Avocado supplement and Avocado included in people with Satiety and Glycemic Index, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satiety (time frame: 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01271829, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2014.