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

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

200

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

University of Illinois at Urbana-Champaign

Collaborators

Hass Avocado Board

Investigators

  • 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

February 1, 2016

Primary Completion (Anticipated)

February 1, 2019

Study Completion (Anticipated)

February 1, 2019

Study Registration Dates

First Submitted

April 11, 2016

First Submitted That Met QC Criteria

April 11, 2016

First Posted (Estimate)

April 15, 2016

Study Record Updates

Last Update Posted (Estimate)

October 17, 2016

Last Update Submitted That Met QC Criteria

October 14, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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