ObesityNCT04763473
AVocAdo Extract to Improve gLycemia in Individuals With Obesity (AVAIL)
A study testing Avocado extract in people with Obesity, run by University of Adelaide at 1 site in Australia.
Trial summary
This two-arm, double blind, randomized clinical trial will compare the effect of an avocado extract, compared to placebo, on cardiometabolic outcomes in adults with obesity. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Avocado extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteAustralia
- Study dates
- 9 Mar 2021to 11 Aug 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women 25 - 65 years old
- Waist circumference (>94cm in men and >80cm in women)
- BMI 30 - 40 kg/m2
- Willingness to provide written informed consent and willingness to participate and comply with the study
Who cannot join
- Women planning pregnancy during the course of the study or 3 months after completion of the study, or who are lactating
- Individuals diagnosed with type 1 or type 2 diabetes mellitus, liver or kidney diseases, neoplastic disease in the previous 3 years, chronic gastrointestinal disorders (including inflammatory bowel disease and celiac), cardiovascular event in the previous 6 months, or any other condition deemed unstable
- Biochemical abnormalities or evidence at screening of disease including elevated liver enzymes ALT and/or AST >3 times normal range limit
- Not weight-stable (< 5 % fluctuation in their body weight for past 6-months at study entry).
- Current or recent (within 12 months) treatment with medication used to lower blood glucose or antidiabetic medications (metformin, sulfonylureas, glucagon-like peptide-1 (GLP-1) analogues [i.e. exenatide], thiazolidinediones or DPP-IV inhibitors [i.e. 'gliptins']), medications affecting weight, appetite or gut motility (i.e. domperidone, cisapride, orlistat, phentermine, topiramate). Participants who are taking stable doses (i.e. > 12 months) of androgenic medications (i.e. testosterone), thyroxine, corticosteroids, anti-depressants (selective serotonin reuptake inhibitors), anti-hypertensives (ace-inhibitors, calcium channel blockers, beta-blockers, diuretics) and lipid lowering medications (statins, fibrates) will not be excluded.
- Participants who have had bariatric surgery
- Participants with conditions that may interfere with the ability to understand the requirements of the study.
Trial locations and contacts
1 site in 1 country.
About this study
This two-arm, double blind, randomized clinical trial will compare the effect of an avocado extract, compared to placebo, on cardiometabolic outcomes in adults with obesity.
Read the detailed description
Sixty eligible participants will be stratified by sex and randomly assigned to placebo or avocado extract supplementation group for 12 weeks. Metabolic testing will be performed at baseline, and at the end of the intervention.
- Conditions
- Obesity
- Being tested
- Avocado extract, Placebo
- Keywords
- Obesity, Avocado extract, Cardiometabolic health
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avocado extractDietary supplement
Participants will consume 10 grams of freeze dried avocado daily for 12 weeks.
PlaceboDietary supplement
Participants will consume 10 grams of corn meal daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants will consume 10 grams of corn meal daily for 12 weeks. Receives: Dietary Supplement: Placebo |
| Avocado extract | Experimental | Participants will consume 10 grams of freeze dried avocado daily for 12 weeks. Receives: Dietary Supplement: Avocado extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic response
Change in glucose area under the curve (AUC) in response to 75 g oral glucose tolerance test
Measured: 12 weeks
Secondary outcomes (12)
Fasting glucose
Change in fasting glucose
Measured: 12 weeks
Fasting insulin
Change in fasting insulin
Measured: 12 weeks
Postprandial insulin
Change in insulin AUC in response to 75g oral glucose tolerance test
Measured: 12 weeks
Homeostatic model assessment of insulin resistance (HOMA-IR)
Change in HOMA-IR
Measured: 12 weeks
Body weight
Change in body weight
Measured: 12 weeks
Waist circumference
Change in waist circumference
Measured: 12 weeks
Body composition
Change in body composition assessed by dual-energy X-ray absorptiometry (DEXA)
Measured: 12 weeks
Blood pressure
Change in systolic and diastolic blood pressure
Measured: 12 weeks
Blood lipids
Change in total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol and triglycerides
Measured: 12 weeks
C-reactive protein
Change in blood C-reactive protein
Measured: 12 weeks
Oxidative stress
Change in blood isoprostane
Measured: 12 weeks
Autophagy
Changes in blood mRNA levels of autophagy markers
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start9 Mar 2021
- Primary completion11 Aug 2022
- Study completion11 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Adelaide
- Sponsor type
- University, hospital or other
- Collaborators
- Isagenix International LLC, Commonwealth Scientific and Industrial Research Organisation, Australia, Prolongevity Technologies
- Responsible party
- Principal investigator, A/Prof Leonie Heilbronn, University of Adelaide
- Investigators
- Leonie Heilbronn, Principal investigator, The University of Adelaide
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04763473
- Sponsor's protocol ID
- H-2020-248
- Status last verified
- Apr 2023
- First submitted
- 16 Feb 2021
- Last updated
- 10 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AVocAdo Extract to Improve gLycemia in Individuals With Obesity (AVAIL)
- ClinicalTrials.gov ID
- NCT04763473
- Acronym / sponsor ID
- H-2020-248
- Conditions
- Obesity
- Keywords
- Obesity, Avocado extract, Cardiometabolic health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of AdelaideUniversity, hospital or other
- Collaborators
- Isagenix International LLC, Commonwealth Scientific and Industrial Research Organisation, Australia, Prolongevity Technologies
- Study start
- 9 Mar 2021 (actual)
- Primary completion
- 11 Aug 2022 (actual)
- Study completion
- 11 Aug 2022 (actual)
- First posted
- 21 Feb 2021 (actual)
- 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.
This two-arm, double blind, randomized clinical trial will compare the effect of an avocado extract, compared to placebo, on cardiometabolic outcomes in adults with obesity.
Detailed description
Sixty eligible participants will be stratified by sex and randomly assigned to placebo or avocado extract supplementation group for 12 weeks. Metabolic testing will be performed at baseline, and at the end of the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants will consume 10 grams of corn meal daily for 12 weeks. |
| Avocado extract | Experimental | Dietary Supplement: Avocado extractParticipants will consume 10 grams of freeze dried avocado daily for 12 weeks. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women 25 - 65 years old
- Waist circumference (>94cm in men and >80cm in women)
- BMI 30 - 40 kg/m2
- Willingness to provide written informed consent and willingness to participate and comply with the study
Key exclusion criteria (7 listed)
- Women planning pregnancy during the course of the study or 3 months after completion of the study, or who are lactating
- Individuals diagnosed with type 1 or type 2 diabetes mellitus, liver or kidney diseases, neoplastic disease in the previous 3 years, chronic gastrointestinal disorders (including inflammatory bowel disease and celiac), cardiovascular event in the previous 6 months, or any other condition deemed unstable
- Biochemical abnormalities or evidence at screening of disease including elevated liver enzymes ALT and/or AST >3 times normal range limit
- Not weight-stable (< 5 % fluctuation in their body weight for past 6-months at study entry).
- Current or recent (within 12 months) treatment with medication used to lower blood glucose or antidiabetic medications (metformin, sulfonylureas, glucagon-like peptide-1 (GLP-1) analogues [i.e. exenatide], thiazolidinediones or DPP-IV inhibitors [i.e. 'gliptins']), medications affecting weight, appetite or gut motility (i.e. domperidone, cisapride, orlistat, phentermine, topiramate). Participants who are taking stable doses (i.e. > 12 months) of androgenic medications (i.e. testosterone), thyroxine, corticosteroids, anti-depressants (selective serotonin reuptake inhibitors), anti-hypertensives (ace-inhibitors, calcium channel blockers, beta-blockers, diuretics) and lipid lowering medications (statins, fibrates) will not be excluded.
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 extractParticipants will consume 10 grams of freeze dried avocado daily for 12 weeks. | Dietary supplement | Avocado extract |
| PlaceboParticipants will consume 10 grams of corn meal daily for 12 weeks. | Dietary supplement | Placebo |
Primary outcome
Glycemic response
Time frame: 12 weeks
Change in glucose area under the curve (AUC) in response to 75 g oral glucose tolerance test
12 secondary outcomes
Fasting glucose
Time frame: 12 weeks
Fasting insulin
Time frame: 12 weeks
Postprandial insulin
Time frame: 12 weeks
Homeostatic model assessment of insulin resistance (HOMA-IR)
Time frame: 12 weeks
Body weight
Time frame: 12 weeks
Waist circumference
Time frame: 12 weeks
Body composition
Time frame: 12 weeks
Blood pressure
Time frame: 12 weeks
Blood lipids
Time frame: 12 weeks
C-reactive protein
Time frame: 12 weeks
Oxidative stress
Time frame: 12 weeks
Autophagy
Time frame: 12 weeks
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 10 Apr 2023.
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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.
Leonie Heilbronn principal investigator
The University of Adelaide
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 extract in people with Obesity, run by University of Adelaide at 1 site in Australia.
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 7 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 10 Apr 2023. 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 Australia. 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?
Glycemic response (time frame: 12 weeks). 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 10 Apr 2023.