Glycemic ResponseAVOC1NCT02479048
Avocado Fruit on Postprandial Markers of the Glycemic Response, Satiety/Appetite and Cardiometabolic Risk
A study testing Test meal 1 and Test meal 2 in people with Glycemic Response, run by Clinical Nutrition Research Center, Illinois Institute of Technology at 1 site in United States.
Trial summary
The primary goal is to characterize the acute effects of avocado intake on glycemic and satiety/ appetite responses in relatively healthy overweight / obese adults. The secondary goal is to investigate risk factors for cardio-metabolic disease. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Glycemic Response
- What is being tested?
- Test meal 1 and Test meal 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2015to 1 Oct 2019
- 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 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women aged 25-60 yrs.
- BMI of 25 - 35 kg/m2
- No clinical evidence / history of cardiovascular, respiratory, renal, gastrointestinal, or hepatic disease
- Not taking over-the-counter or prescription medications / dietary supplements that may interfere with study procedures or endpoints (e.g., antioxidant supplements, anti-inflammatory, lipid-lowering or blood pressure lowering medications.
- Fasting blood glucose of 90-115 mg/dl
- Fasting insulin < 13 U/L
- Non-smoker or past smoker (smoking cessation > 2 yrs.)
- has at least 1 large, sturdy and well anchored vein in order to place a catheter
Who cannot join
- Aged < 25 or > 60 years
- BMI < 25 kg/m2 or > 35 kg/m2
- History of cardiovascular, respiratory, renal, gastrointestinal or hepatic disease
- Diabetes
- Uncontrolled blood pressure (>140 / 90 mmHg)
- Have or had cancer other than non-melanoma skin cancer in past 5 years
Show all 18Show fewer
- Taking over-the-counter or prescription medications or dietary supplements that may interfere with study procedures or endpoints (including protein powers, energy drinks)
- Fasting blood glucose <90 or > 115 mg/dl
- Fasting insulin ≥ 13 U/L
- Vegan dietary habits, unusual dietary habits or sensitive or allergic to any of the test meal components / ingredients
- Dislike avocados or non-consumers of avocados
- Current smoker
- Actively losing weight or trying to lose weight
- Drug or alcohol addiction
- Present with significant psychiatric or neurological disturbances
- Pregnant, lactating or planning to become pregnant
- Consuming 3 or more servings nuts or peanuts per week
- has no accessible vein site for placing a catheter
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Nutrition Research Center
Chicago, Illinois, 60616
About this study
Official title: The Impact of Avocado Fruit on Postprandial Markers of the Glycemic Response, Satiety/Appetite and Cardiometabolic Risk: An Acute Dose Response Study
The primary goal is to characterize the acute effects of avocado intake on glycemic and satiety/ appetite responses in relatively healthy overweight / obese adults. The secondary goal is to investigate risk factors for cardio-metabolic disease.
Read the detailed description
The trial is a single center randomized, 3-arm, controlled, within-subject crossover study utilizing a multiple sampling, repeated measures paradigm. The trial will test 3 treatment conditions in 30 relatively healthy men and women 25-60 years of age. Study treatments include Control (without avocado), Test Meal 1 (1/2 avocado; ~68g), and Test Meal 2 (1 Avocado; ~136g).
Subjects will be required to meet several inclusion and exclusion criteria, which will be assessed through online and clinic mechanisms, including questionnaires, blood analysis and anthropometric measures. Eligible subjects will be invited to participate in the study. Each subject will be asked to come for one Information Session/Screening Visit, one Pre-Study Visit, three dinner pick-ups (the day before each test day visit) and three Test Day Visits. Subjects will be randomized to receive test treatments based on randomization schedule at the Pre-Study Visit.
During the Pre-Study Visit subjects will be instructed on the process for completing study questionnaires and counseled to restrict avocado intake and intake of colored plant foods rich in phytonutrients the 3 days prior to each Test Day Visit. They will be asked to restrict alcohol intake, coffee/tea/ caffeinated beverage intake and moderate / vigorous physical activity and to drink plenty of water to maintain hydration in the 24 h prior to each Test Day Visit. They will be instructed to come to the CNRC the day before each Test Day Visit to pick up their dinner meal and evening snack. Subjects will be asked to get at least 7 hours sleep and to come to the CNRC after an overnight fast of 10 h on each Test Day Visit.
Each Test Day Visit will require subjects to be in the clinic for ~7 h to complete all baseline and post challenge meal testing procedures. Subjects will be evaluated for compliance with the protocol (diet, exercise, sleep, fasting), have their body weight and blood pressure measured and baseline flow mediated dilation (FMD) will be recoded before placement of a catheter and baseline blood sample is taken. Baseline subjective satiety will be measured by visual analogue scale (VAS) just before consuming one of the 3 breakfast treatment meals. FMD will be measured at 2 time points after breakfast and blood samples and VAS questionnaires will be collected at multiple time points over the 6 h postprandial period.
- Conditions
- Glycemic Response
- Being tested
- Test meal 1, Test meal 2, Control Meal (CM)
- Keywords
- satiety/appetite, glycemic response, cardiometabolic risk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test meal 1Dietary supplement
High fat meal (HF) with ½ avocado (~68g), matched to CM for energy content; not matched for macronutrient content or type (e.g., fat type).
Test meal 2Dietary supplement
High fat meal (HF) with 1 avocado (~136g) matched for energy but not macronutrient content or type.
Control Meal (CM)Dietary supplement
High carbohydrate, high saturated fat control meal (CM) without avocado.
| Study group | Role | What they receive |
|---|---|---|
| Test meal 1 (TM1) | Active comparator | High fat meal (HF) with ½ avocado (~68g) Receives: Dietary Supplement: Test meal 1 |
| Test meal 2 (TM2) | Active comparator | High fat meal (HF) with 1 avocado (~136g) Receives: Dietary Supplement: Test meal 2 |
| Control meal (CM) | Placebo comparator | High carbohydrate, high saturated fat control meal (CM) without avocado. Receives: Dietary Supplement: Control Meal (CM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in postprandial blood glucose concentration response for treatments compared to control over 6-hour postprandial period
postprandial blood glucose concentration response
Measured: Baseline to 6 hours
Secondary outcomes (4)
Changes in postprandial endothelial function using Flow Mediated Dilation (FMD) for treatments compared to control
postprandial endothelial function using Flow Mediated Dilation (FMD)
Measured: Baseline to 6 hours
Change in postprandial blood insulin and triglycerides concentration response for treatments compared to control over 6-hour postprandial period
postprandial blood insulin and triglycerides concentration response
Measured: Baseline to 6 hours
Changes in postprandial subjective satiety responses using visual analog scales (VAS) for treatments compared to control over 6-hour postprandial period
postprandial subjective satiety responses using visual analog scales (VAS)
Measured: Baseline to 6 hours
Changes in postprandial gut hormones related to satiety for treatments compared to control over 6-hour postprandial period
postprandial gut hormones related to satiety for treatments
Measured: Baseline to 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study start1 Jun 2015
- Primary completion1 Oct 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glycemic ResponseStudies of the same condition, open and under way.
- More trials run by Clinical Nutrition Research Center, Illinois Institute of TechnologyThe sponsor's other registered studies.
- 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Britt Burton-Freeman, Ph.D, Principal investigator, Illinois Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02479048
- Sponsor's protocol ID
- IRB2015-001
- Acronym
- AVOC1
- Status last verified
- Jul 2020
- First submitted
- 19 Jun 2015
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Avocado Fruit on Postprandial Markers of the Glycemic Response, Satiety/Appetite and Cardiometabolic Risk: An Acute Dose Response Study
- ClinicalTrials.gov ID
- NCT02479048
- Acronym / sponsor ID
- AVOC1 / IRB2015-001
- Conditions
- Glycemic Response
- Keywords
- satiety/appetite, glycemic response, cardiometabolic risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Clinical Nutrition Research Center, Illinois Institute of TechnologyIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 23 Jun 2015 (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 primary goal is to characterize the acute effects of avocado intake on glycemic and satiety/ appetite responses in relatively healthy overweight / obese adults. The secondary goal is to investigate risk factors for cardio-metabolic disease.
Detailed description
The trial is a single center randomized, 3-arm, controlled, within-subject crossover study utilizing a multiple sampling, repeated measures paradigm. The trial will test 3 treatment conditions in 30 relatively healthy men and women 25-60 years of age. Study treatments include Control (without avocado), Test Meal 1 (1/2 avocado; ~68g), and Test Meal 2 (1 Avocado; ~136g).
Subjects will be required to meet several inclusion and exclusion criteria, which will be assessed through online and clinic mechanisms, including questionnaires, blood analysis and anthropometric measures. Eligible subjects will be invited to participate in the study. Each subject will be asked to come for one Information Session/Screening Visit, one Pre-Study Visit, three dinner pick-ups (the day before each test day visit) and three Test Day Visits. Subjects will be randomized to receive test treatments based on randomization schedule at the Pre-Study Visit.
During the Pre-Study Visit subjects will be instructed on the process for completing study questionnaires and counseled to restrict avocado intake and intake of colored plant foods rich in phytonutrients the 3 days prior to each Test Day Visit. They will be asked to restrict alcohol intake, coffee/tea/ caffeinated beverage intake and moderate / vigorous physical activity and to drink plenty of water to maintain hydration in the 24 h prior to each Test Day Visit. They will be instructed to come to the CNRC the day before each Test Day Visit to pick up their dinner meal and evening snack. Subjects will be asked to get at least 7 hours sleep and to come to the CNRC after an overnight fast of 10 h on each Test Day Visit.
Each Test Day Visit will require subjects to be in the clinic for ~7 h to complete all baseline and post challenge meal testing procedures. Subjects will be evaluated for compliance with the protocol (diet, exercise, sleep, fasting), have their body weight and blood pressure measured and baseline flow mediated dilation (FMD) will be recoded before placement of a catheter and baseline blood sample is taken. Baseline subjective satiety will be measured by visual analogue scale (VAS) just before consuming one of the 3 breakfast treatment meals. FMD will be measured at 2 time points after breakfast and blood samples and VAS questionnaires will be collected at multiple time points over the 6 h postprandial period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test meal 1 (TM1) | Active comparator | Dietary Supplement: Test meal 1High fat meal (HF) with ½ avocado (~68g) |
| Test meal 2 (TM2) | Active comparator | Dietary Supplement: Test meal 2High fat meal (HF) with 1 avocado (~136g) |
| Control meal (CM) | Placebo comparator | Dietary Supplement: Control Meal (CM)High carbohydrate, high saturated fat control meal (CM) without avocado. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Men and women aged 25-60 yrs.
- BMI of 25 - 35 kg/m2
- No clinical evidence / history of cardiovascular, respiratory, renal, gastrointestinal, or hepatic disease
- Not taking over-the-counter or prescription medications / dietary supplements that may interfere with study procedures or endpoints (e.g., antioxidant supplements, anti-inflammatory, lipid-lowering or blood pressure lowering medications.
- Fasting blood glucose of 90-115 mg/dl
Key exclusion criteria (18 listed)
- Aged < 25 or > 60 years
- BMI < 25 kg/m2 or > 35 kg/m2
- History of cardiovascular, respiratory, renal, gastrointestinal or hepatic disease
- Diabetes
- Uncontrolled blood pressure (>140 / 90 mmHg)
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 |
|---|---|---|
| Test meal 1High fat meal (HF) with ½ avocado (~68g), matched to CM for energy content; not matched for macronutrient content or type (e.g., fat type). | Dietary supplement | Test meal 1 (TM1) |
| Test meal 2High fat meal (HF) with 1 avocado (~136g) matched for energy but not macronutrient content or type. | Dietary supplement | Test meal 2 (TM2) |
| Control Meal (CM)High carbohydrate, high saturated fat control meal (CM) without avocado. | Dietary supplement | Control meal (CM) |
Primary outcome
Change in postprandial blood glucose concentration response for treatments compared to control over 6-hour postprandial period
Time frame: Baseline to 6 hours
postprandial blood glucose concentration response
4 secondary outcomes
Changes in postprandial endothelial function using Flow Mediated Dilation (FMD) for treatments compared to control
Time frame: Baseline to 6 hours
Change in postprandial blood insulin and triglycerides concentration response for treatments compared to control over 6-hour postprandial period
Time frame: Baseline to 6 hours
Changes in postprandial subjective satiety responses using visual analog scales (VAS) for treatments compared to control over 6-hour postprandial period
Time frame: Baseline to 6 hours
Changes in postprandial gut hormones related to satiety for treatments compared to control over 6-hour postprandial period
Time frame: Baseline to 6 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 14 Jul 2020.
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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.
Britt Burton-Freeman, Ph.D principal investigator
Illinois Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test meal 1 and Test meal 2 in people with Glycemic Response, run by Clinical Nutrition Research Center, Illinois Institute of Technology 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 8 inclusion and 18 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 14 Jul 2020. 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. Some participants in this study may receive a placebo. 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?
Change in postprandial blood glucose concentration response for treatments compared to control over 6-hour postprandial period (time frame: Baseline to 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2020.