NCT04763473

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
16 days until next milestone

Study Start

First participant enrolled

March 9, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2022

Completed
Last Updated

April 10, 2023

Status Verified

April 1, 2023

Enrollment Period

1.4 years

First QC Date

February 16, 2021

Last Update Submit

April 6, 2023

Conditions

Obesity

Keywords

ObesityAvocado extractCardiometabolic health

Outcome Measures

Primary Outcomes (1)

  • Glycemic response

    Change in glucose area under the curve (AUC) in response to 75 g oral glucose tolerance test

    12 weeks

Secondary Outcomes (12)

  • Fasting glucose

    12 weeks

  • Fasting insulin

    12 weeks

  • Postprandial insulin

    12 weeks

  • Homeostatic model assessment of insulin resistance (HOMA-IR)

    12 weeks

  • Body weight

    12 weeks

  • +7 more secondary outcomes

Study Arms (2)

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

Avocado extractDIETARY_SUPPLEMENT

Participants will consume 10 grams of freeze dried avocado daily for 12 weeks.

Avocado extract
PlaceboDIETARY_SUPPLEMENT

Participants will consume 10 grams of corn meal daily for 12 weeks.

Placebo

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Adelaide

Adelaide, South Australia, 5000, Australia

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Leonie Heilbronn

    The University of Adelaide

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 16, 2021

First Posted

February 21, 2021

Study Start

March 9, 2021

Primary Completion

August 11, 2022

Study Completion

August 11, 2022

Last Updated

April 10, 2023

Record last verified: 2023-04

Locations

AU(1)