Persea Americana for Total Health (PATH ) Study (PATH)

October 14, 2016 updated by: University of Illinois at Urbana-Champaign

Investigating the Effects of Avocado Intake on Metabolism and Cognition: A Systems Approach

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • University of Illinois, Urbana-Champaign
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention Meal
Intervention meals will contain 1 large avocado and be consumed daily for 12 weeks.
Other: Avocado
The intervention meals will contain 1 large 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
The control meals will be isocaloric to the intervention meals but will not contain avocado.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Abdominal obesity
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Changes to abdominal and whole body composition including visceral and subcutaneous adipose tissue will be estimated by DEXA.
Baseline, 4 weeks, 8 weeks, 12 weeks
Glycemic Control
Time Frame: Baseline, 4 weeks, 8 weeks,12 weeks
Glycemic control will be assessed using oral glucose tolerance tests and hemoglobin A1c.
Baseline, 4 weeks, 8 weeks,12 weeks
Insulin Resistance
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Insulin resistance will be evaluated using the Homeostasis Assessment Model (HOMA) index.
Baseline, 4 weeks, 8 weeks, 12 weeks
Insulin Sensitivity
Time Frame: Baseline, 12 weeks
Insulin sensitivity will be assessed using the insulinogenic index, Stumvoll Metabolic Clearance Rate, Oral Glucose Insulin Sensitivity, and the Matsuda Index.
Baseline, 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gastrointestinal Microbiota Composition and Short Chain Fatty Acids
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Microbial taxonomy will be assessed using high throughput sequencing and short chain fatty acids will be quantified using gas chromatography and mass spectrometry.
Baseline, 4 weeks, 8 weeks, 12 weeks
Cognitive Function
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Cognitive function will be evaluated using tasks that measure prefrontal cognitive control and hippocampal relational memory networks.
Baseline, 4 weeks, 8 weeks, 12 weeks
Retinal Lutein
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Retinal lutein will be assessed using Macular Pigment Optical Density.
Baseline, 4 weeks, 8 weeks, 12 weeks
Serum Lutein
Time Frame: Baseline, 12 weeks
Serum lutein will be assessed using venous blood samples.
Baseline, 12 weeks
Blood Lipid Panel
Time Frame: Baseline, 12 weeks
Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides will be assessed using venous blood samples.
Baseline, 12 weeks
Resting Energy Expenditure
Time Frame: Baseline, 12 weeks
REE will be measured by indirect calorimetry.
Baseline, 12 weeks
Neuroelectric Assessment
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks
A Neuroelectric Assessment will be conducted during cognitive tasks using an Electroencephalogram (EEG) amplifier.
Baseline, 4 weeks, 8 weeks, 12 weeks
DNA Analyses
Time Frame: Baseline
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.
Baseline
Dietary Intake
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks
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.
Baseline, 4 weeks, 8 weeks, 12 weeks
Sleep and Fatigue
Time Frame: Baseline, 12 weeks
Sleep and fatigue will be evaluated using the Pittsburgh Sleep Quality Index
Baseline, 12 weeks
Physical Activity
Time Frame: Baseline, 12 weeks
Physical activity will be measured over 7 day periods by a waist mounted accelerometer.
Baseline, 12 weeks
Blood Pressure
Time Frame: Baseline, 12 weeks
Blood pressure will be measured using an automatic blood pressure cuff.
Baseline, 12 weeks
Liver Enzymes
Time Frame: Baseline, 12 weeks
Liver enzymes will be assessed using venous blood samples.
Baseline, 12 weeks
Inflammatory Markers
Time Frame: Baseline, 12 weeks
Markers of inflammation such as c-reactive protein (CRP) will be assessed using venous blood samples.
Baseline, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Illinois at Urbana-Champaign

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hass Avocado Board

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hannah D Holscher, PhD RD, University of Illinois at Urbana-Champaign

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 11, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 15, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 17, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16277

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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