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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04763473




Registration number
NCT04763473
Ethics application status
Date submitted
16/02/2021
Date registered
21/02/2021
Date last updated
10/04/2023

Titles & IDs
Public title
AVocAdo Extract to Improve gLycemia in Individuals With Obesity (AVAIL)
Scientific title
AVocAdo Extract to Improve gLycemia in Individuals With Obesity (AVAIL)
Secondary ID [1] 0 0
H-2020-248
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Avocado extract
Other interventions - Placebo

Placebo Comparator: Placebo - Participants will consume 10 grams of corn meal daily for 12 weeks.

Experimental: Avocado extract - Participants will consume 10 grams of freeze dried avocado daily for 12 weeks.


Other interventions: Avocado extract
Participants will consume 10 grams of freeze dried avocado daily for 12 weeks.

Other interventions: Placebo
Participants will consume 10 grams of corn meal daily for 12 weeks.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Glycemic response
Timepoint [1] 0 0
12 weeks
Secondary outcome [1] 0 0
Fasting glucose
Timepoint [1] 0 0
12 weeks
Secondary outcome [2] 0 0
Fasting insulin
Timepoint [2] 0 0
12 weeks
Secondary outcome [3] 0 0
Postprandial insulin
Timepoint [3] 0 0
12 weeks
Secondary outcome [4] 0 0
Homeostatic model assessment of insulin resistance (HOMA-IR)
Timepoint [4] 0 0
12 weeks
Secondary outcome [5] 0 0
Body weight
Timepoint [5] 0 0
12 weeks
Secondary outcome [6] 0 0
Waist circumference
Timepoint [6] 0 0
12 weeks
Secondary outcome [7] 0 0
Body composition
Timepoint [7] 0 0
12 weeks
Secondary outcome [8] 0 0
Blood pressure
Timepoint [8] 0 0
12 weeks
Secondary outcome [9] 0 0
Blood lipids
Timepoint [9] 0 0
12 weeks
Secondary outcome [10] 0 0
C-reactive protein
Timepoint [10] 0 0
12 weeks
Secondary outcome [11] 0 0
Oxidative stress
Timepoint [11] 0 0
12 weeks
Secondary outcome [12] 0 0
Autophagy
Timepoint [12] 0 0
12 weeks

Eligibility
Key inclusion criteria
- 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
Minimum age
25 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/03/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/08/2022
Sample size
Target
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
The University of Adelaide - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
University of Adelaide
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Isagenix International LLC
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Commonwealth Scientific and Industrial Research Organisation, Australia
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/Industry
Name [3] 0 0
Prolongevity Technologies
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04763473
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Leonie Heilbronn
Address 0 0
The University of Adelaide
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04763473