CClinicalTrials.gg
Status unknownNCT02740439PATHUpdated Oct 17, 2016

Persea Americana for Total Health (PATH ) Study

An interventional study of Avocado and Control in Obesity, Abdominal, Insulin Resistance and Insulin Sensitivity, sponsored by University of Illinois at Urbana-Champaign. Status unknown at 1 site in United States. Open to participants aged 25 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-10-17.

Sponsored by University of Illinois at Urbana-Champaign · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
25 Years to 45 Years
Sex
All
01

Study summary

The proposed work will investigate the effects of avocados on abdominal obesity and glycemic control among overweight/obese adults.

Read the detailed description

The proposed work will investigate the effects of avocados on abdominal obesity and glycemic control among overweight/obese adults. Further, changes in GI microbiota composition and cognitive function will be assessed to comprehensively understand systemic benefits of avocado consumption on gut and brain function. This research study has two aims: 1) To determine the effects of regular avocado intake on metabolic syndrome risk factors, specifically, abdominal obesity and glycemic control, among overweight and obese adults; and 2) to investigate the implications of avocado intake on measures of GI microbiota composition and cognitive function.

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Conditions studied

  • Obesity, Abdominal
  • Insulin Resistance
  • Insulin Sensitivity
03

In context

Insulin Resistance

1,960 studies on the registry are indexed under Insulin Resistance; 306 are open to participants now.

This study's planned enrollment of 200 is above the median of 40 across 1,536 interventional studies indexed under Insulin Resistance.

Browse Insulin Resistance studies →

Lead sponsor

University of Illinois at Urbana-Champaign is the lead sponsor of 188 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
25 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Males and females
  • Between the ages of 25-45 years at the time of consent
  • Body mass index ≥27.5kg/m2
  • Normal or corrected-to-normal vision based on the minimal 20/20 standard in order to complete the cognitive task (below 20/20 vision).
  • Ability to drop-off fecal sample within 15 minutes of defecation

Exclusion criteria

Exclusion Criteria:

  • Current pregnancy or lactation
  • Tobacco use
  • Avocado allergy or intolerance
  • Food allergies, lactose intolerance
  • Latex allergy
  • Prior diagnosis of metabolic and gastrointestinal disease (cardiovascular disease and type 1 or type 2 diabetes, chronic constipation, diarrhea, Crohn's disease, celiac disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers, hepatitis, HIV, cancer, etc.)
  • Prior diagnosis of cognitive or physical disability, including ADHD, severe asthma, epilepsy, chronic kidney disease, and dependence upon a wheelchair/walking
  • Use of any anti-psychotic, anti-depressant, anti-anxiety, or ADD/ADHD medications
  • Use of medications that alter normal bowel function and metabolism (e.g., recent antibiotic use, laxatives, enemas, anti-diarrheal agents, narcotics, antacids, antispasmodics, diuretics, anticonvulsants).
  • High BMI that is not representative of being overweight or obese (e.g. resistance trained individuals, football players)
  • Prior malabsorptive bariatric surgery (i.e. gastric bypass, sleeve gastrectomy) or restrictive bariatric surgery (i.e. adjustable gastric band) within the past 2 years
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Intervention Meal

    Intervention meals will contain 1 large avocado and be consumed daily for 12 weeks.

    Other: Avocado

  • Placebo comparator
    Control Meal

    Control meals will be isocaloric to the intervention meals but without avocado. They will also be consumed daily for 12 weeks.

    Other: Control

Interventions

  • OtherAvocado

    The intervention meals will contain 1 large avocado.

  • OtherControl

    The control meals will be isocaloric to the intervention meals but will not contain avocado.

06

What researchers measure

Primary outcomes

  1. Abdominal obesity

    Changes to abdominal and whole body composition including visceral and subcutaneous adipose tissue will be estimated by DEXA.

    Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks

  2. Glycemic Control

    Glycemic control will be assessed using oral glucose tolerance tests and hemoglobin A1c.

    Time frame: Baseline, 4 weeks, 8 weeks,12 weeks

  3. Insulin Resistance

    Insulin resistance will be evaluated using the Homeostasis Assessment Model (HOMA) index.

    Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks

  4. Insulin Sensitivity

    Insulin sensitivity will be assessed using the insulinogenic index, Stumvoll Metabolic Clearance Rate, Oral Glucose Insulin Sensitivity, and the Matsuda Index.

    Time frame: Baseline, 12 weeks

Secondary outcomes

  1. Gastrointestinal Microbiota Composition and Short Chain Fatty Acids

    Microbial taxonomy will be assessed using high throughput sequencing and short chain fatty acids will be quantified using gas chromatography and mass spectrometry.

    Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks

  2. Cognitive Function

    Cognitive function will be evaluated using tasks that measure prefrontal cognitive control and hippocampal relational memory networks.

    Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks

  3. Retinal Lutein

    Retinal lutein will be assessed using Macular Pigment Optical Density.

    Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks

  4. Serum Lutein

    Serum lutein will be assessed using venous blood samples.

    Time frame: Baseline, 12 weeks

  5. Blood Lipid Panel

    Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides will be assessed using venous blood samples.

    Time frame: Baseline, 12 weeks

  6. Resting Energy Expenditure

    REE will be measured by indirect calorimetry.

    Time frame: Baseline, 12 weeks

  7. Neuroelectric Assessment

    A Neuroelectric Assessment will be conducted during cognitive tasks using an Electroencephalogram (EEG) amplifier.

    Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks

  8. DNA Analyses

    Genetic markers related to obesity and cognitive function will be assessed using blood samples to determine the mediating effects of genetics on changes related to study outcomes.

    Time frame: Baseline

  9. Dietary Intake

    Dietary intake will be evaluated using 7 day diet records at baseline, 4, 8, and 12 weeks and by NCI NHANES 30-day food frequency questionnaires at baseline and 12 weeks.

    Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks

  10. Sleep and Fatigue

    Sleep and fatigue will be evaluated using the Pittsburgh Sleep Quality Index

    Time frame: Baseline, 12 weeks

  11. Physical Activity

    Physical activity will be measured over 7 day periods by a waist mounted accelerometer.

    Time frame: Baseline, 12 weeks

  12. Blood Pressure

    Blood pressure will be measured using an automatic blood pressure cuff.

    Time frame: Baseline, 12 weeks

  13. Liver Enzymes

    Liver enzymes will be assessed using venous blood samples.

    Time frame: Baseline, 12 weeks

  14. Inflammatory Markers

    Markers of inflammation such as c-reactive protein (CRP) will be assessed using venous blood samples.

    Time frame: Baseline, 12 weeks

07

Study locations

1 of 1 sites recruiting
  • University of Illinois, Urbana-Champaign
    Urbana, Illinois 61801, United States
    Recruiting
08

References and documents

Publications

  • Khan NA, Edwards CG, Thompson SV, Hannon BA, Burke SK, Walk ADM, Mackenzie RWA, Reeser GE, Fiese BH, Burd NA, Holscher HD. Avocado Consumption, Abdominal Adiposity, and Oral Glucose Tolerance Among Persons with Overweight and Obesity. J Nutr. 2021 Sep 4;151(9):2513-2521. doi: 10.1093/jn/nxab187. PubMed 34191028 ↗
  • Thompson SV, Bailey MA, Taylor AM, Kaczmarek JL, Mysonhimer AR, Edwards CG, Reeser GE, Burd NA, Khan NA, Holscher HD. Avocado Consumption Alters Gastrointestinal Bacteria Abundance and Microbial Metabolite Concentrations among Adults with Overweight or Obesity: A Randomized Controlled Trial. J Nutr. 2021 Apr 8;151(4):753-762. doi: 10.1093/jn/nxaa219. PubMed 32805028 ↗
  • Edwards CG, Walk AM, Thompson SV, Reeser GE, Erdman JW Jr, Burd NA, Holscher HD, Khan NA. Effects of 12-week avocado consumption on cognitive function among adults with overweight and obesity. Int J Psychophysiol. 2020 Feb;148:13-24. doi: 10.1016/j.ijpsycho.2019.12.006. Epub 2019 Dec 14. PubMed 31846631 ↗
  • Jones AR, Robbs CM, Edwards CG, Walk AM, Thompson SV, Reeser GE, Holscher HD, Khan NA. Retinal Morphometric Markers of Crystallized and Fluid Intelligence Among Adults With Overweight and Obesity. Front Psychol. 2018 Dec 21;9:2650. doi: 10.3389/fpsyg.2018.02650. eCollection 2018. PubMed 30622502 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 17, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02740439
Lead sponsor
University of Illinois at Urbana-Champaign
Collaborators
Hass Avocado Board
Responsible party
Sponsor
First posted
Apr 15, 2016
Start date
Feb 2016
Primary completion
Feb 2019 (estimated)
Completion
Feb 2019 (estimated)
Last update
Oct 17, 2016

Study contacts

Hannah D Holscher, PhD RD
Contact
hholsche@illinois.edu
217-300-2512
Naiman A Khan, PhD RD
Contact
nakhan@illinois.edu
217-300-2197
Hannah D Holscher, PhD RD
principal investigator · University of Illinois at Urbana-Champaign

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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