AVocAdo Extract to Improve gLycemia in Individuals With O... | NCT04763473

Studies
AVocAdo Extract to Improve gLycemia in Individuals With Obesity (AVAIL)

NCT04763473

Sponsor

University of Adelaide

Status

Completed

Last Update Posted

Apr 10, 2023Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Obesity

Interventions

Avocado extract
Placebo

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 9, 2021Actual

Primary Completion Date

Aug 11, 2022Actual

Completion Date

Aug 11, 2022Actual

First Submitted Date

Feb 16, 2021

First Submission Date that Met QC Criteria

Feb 16, 2021

First Posted Date

Feb 21, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2023

Last Update Posted Date

Apr 10, 2023Actual

Name	Class
Isagenix International LLC	INDUSTRY
Commonwealth Scientific and Industrial Research Organisation, Australia	OTHER_GOV
Prolongevity Technologies	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Participants will consume 10 grams of corn meal daily for 12 weeks.	Dietary Supplement: Placebo
Avocado extract	Experimental	Participants will consume 10 grams of freeze dried avocado daily for 12 weeks.	Dietary Supplement: Avocado extract

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Avocado extract	Dietary Supplement	Participants will consume 10 grams of freeze dried avocado daily for 12 weeks.	Avocado extract

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Glycemic response	Change in glucose area under the curve (AUC) in response to 75 g oral glucose tolerance test	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Fasting glucose	Change in fasting glucose	12 weeks
Fasting insulin	Change in fasting insulin	12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases