NCT05009420

Brief Summary

The primary objectives are to

  • Identify avocatin b (C17 lipid) in plasma of individuals that consumed 1 avocado.
  • Confirm no avocation b present in the plasma of individuals that avoided avocado intake for 7 days.
  • Determine the effect of an overnight fast on avocation b detection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Jul 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

Study Start

First participant enrolled

July 19, 2021

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 2, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 17, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

February 9, 2023

Status Verified

February 1, 2023

Enrollment Period

6 months

First QC Date

August 2, 2021

Last Update Submit

February 7, 2023

Conditions

Healthy

Keywords

avocado

Outcome Measures

Primary Outcomes (1)

  • changes in avocatin b (C17 lipid) concentration in plasma in healthy individuals, 24 hours after consumed 1 avocado.

    fasting blood sample before eating a avocado compare with fasting blood sample 24 hours after consumed 1 avocado.

    baseline (time point 0) to 24 hours

Secondary Outcomes (1)

  • avocatin b (C17 lipid) concentration in plasma of individuals that avoided avocado intake for 7 days

    Day-7-Day0

Study Arms (1)

Avocado

EXPERIMENTAL

Identify avocatin b (C17 lipid) in plasma of individuals that consumed 1 avocado.

Other: Avocado

Interventions

AvocadoOTHER

avocado served with crackers as breakfast

Avocado

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI 25-35
  • Males/females
  • years of age

You may not qualify if:

  • Does not eat avocados for a reason prohibiting them from being willing to eat 1 avocado
  • Sensitive/allergic to avocados
  • Allergies to latex or oral allergy syndrome
  • Unstable medical conditions such as on dialysis for renal disease, cardiac, gastrointestinal, or hepatic disease, cancer (non-melanoma skin cancer \>5 years ago acceptable, any cancer site \>10yrs without recurrence).
  • Pregnant, lactating, intention of pregnancy
  • Lost or gained 15 lbs of body weight in last 2 months
  • Following restricted or weight loss dietary patterns
  • Elevated alcohol intake (7+ drinks/week females; 14+ drinks/week males)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Nutrition Research Center

Chicago, Illinois, 60616, United States

Location

Study Officials

  • Britt Burton-Freeman, Ph.D

    Illinois Insititute of Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Identify avocatin b (C17 lipid) in plasma of individuals that consumed 1 avocado
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2021

First Posted

August 17, 2021

Study Start

July 19, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

February 9, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)