Trial Outcomes & Findings for Effects of Avocado When Added to a Meat Patty on Inflammation in Healthy Men (NCT NCT01397071)

Results Overview

Change from baseline in reactive hyperemia index (RHI) in response to consumption of 250 g beef patty with or without 68 g avocado added at 2 hour post-ingestion. RHI is a measure of endothelial dysfunction using noninvasive peripheral arterial tonometry (PAT). It is a ratio of the post-to-pre occlusion PAT amplitude of the tested arm, divided by the post-to-pre occlusion ratio of the control arm. RHI less than 1.67 is considered sign of endothelial dysfunction and RHI equal to or greater than 1.67 is considered normal function. The possible range of scores is 1 to 3. Increasing score indicates the improvement of coronary endothelial function.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

11 participants

Primary outcome timeframe

Baseline and 2 hours post-ingestion

Results posted on

2019-09-25

Participant Flow

The enrollment period was 8/2011 to 2/2012. Enrollment took place in a private setting in the clinic located at the site.

17 healthy male volunteers were recruited and screened; 6 failed screen; 11 participants completed crossover study.

Participant milestones

Participant milestones
Measure	Consumption of Beef Patty With or Without Avocado Added Participants consumed 250 g cooked ground beef patty with or without avocado added prior to ingestion.
Consumption of Beef Patty Alone STARTED	11
Consumption of Beef Patty Alone COMPLETED	11
Consumption of Beef Patty Alone NOT COMPLETED	0
Consumption of Beef Patty With Avocado STARTED	11
Consumption of Beef Patty With Avocado COMPLETED	11
Consumption of Beef Patty With Avocado NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Avocado When Added to a Meat Patty on Inflammation in Healthy Men

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Consumption of Beef Patty With or Without Avocado n=11 Participants Participants consumed 250 g cooked ground beef patty with or without 68 g fresh avocado added prior to ingestion.
Age, Continuous	25.4 years STANDARD_DEVIATION 5.7 • n=5 Participants
Sex/Gender, Customized Male participants	11 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants
Race/Ethnicity, Customized Black	2 Participants n=5 Participants
Race/Ethnicity, Customized White	4 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	4 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 2 hours post-ingestion

Change from baseline in reactive hyperemia index (RHI) in response to consumption of 250 g beef patty with or without 68 g avocado added at 2 hour post-ingestion. RHI is a measure of endothelial dysfunction using noninvasive peripheral arterial tonometry (PAT). It is a ratio of the post-to-pre occlusion PAT amplitude of the tested arm, divided by the post-to-pre occlusion ratio of the control arm. RHI less than 1.67 is considered sign of endothelial dysfunction and RHI equal to or greater than 1.67 is considered normal function. The possible range of scores is 1 to 3. Increasing score indicates the improvement of coronary endothelial function.

Outcome measures

Outcome measures
Measure	Participants Consumed 250 g Beef Patties Alone n=11 Participants Participants consumed 250 g beef patties without avocado added	Participants Consumed 250 g Beef Patties With Avocado Added n=11 Participants Participants consumed 250 g beef patties with 68 g avocado added prior to ingestion.
Change of Endothelial Function by Measurement of Flow-mediated Vasodilation Using the Reactive Hyperemia Index (RHI) PAT index before intervention	2.20 score on a scale Standard Deviation 0.36	2.17 score on a scale Standard Deviation 0.57
Change of Endothelial Function by Measurement of Flow-mediated Vasodilation Using the Reactive Hyperemia Index (RHI) PAT index at 2 hr after intervention	1.56 score on a scale Standard Deviation 0.21	2.08 score on a scale Standard Deviation 0.51

SECONDARY outcome

Timeframe: 0 (baseline) and 3 hours post-ingestion

Change from baseline inflammatory marker IkB-alpha in response to the consumption of 250 g beef patty with or without 68 g avocado added was assessed at 0 (baseline), 1, 2, 3, 4, 5, 6 hours post-ingestion. Baseline and 3 hours post-ingestion was reported.

Outcome measures

Outcome measures
Measure	Participants Consumed 250 g Beef Patties Alone n=11 Participants Participants consumed 250 g beef patties without avocado added	Participants Consumed 250 g Beef Patties With Avocado Added n=11 Participants Participants consumed 250 g beef patties with 68 g avocado added prior to ingestion.
Change in Inflammation Marker Nuclear Factor of Kappa Light Polypeptide Gene Enhancer in B-cells Inhibitor Alpha (IkB-alpha) IkB-alpha at baseline	100 percentage of baseline Standard Deviation 0.0	100 percentage of baseline Standard Deviation 0.0
Change in Inflammation Marker Nuclear Factor of Kappa Light Polypeptide Gene Enhancer in B-cells Inhibitor Alpha (IkB-alpha) IkB-alpha 3 h after intervention	57.8 percentage of baseline Standard Deviation 15	131.3 percentage of baseline Standard Deviation 26.8

Adverse Events

Change in PAT After Consuming Beef Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Change in PAT After Comsuming Beef With Avocado

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Zhaoping Li

UCLA Department of Medicine/Center for Human Nutrition

Phone: 310-206-1987

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place