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

Primary Purpose

Obesity, Abdominal, Insulin Resistance, Insulin Sensitivity

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Avocado
Control
Sponsored by
University of Illinois at Urbana-Champaign
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity, Abdominal

Eligibility Criteria

25 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Illinois, Urbana-ChampaignRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention Meal

Control Meal

Arm Description

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

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

Outcomes

Primary Outcome Measures

Abdominal obesity
Changes to abdominal and whole body composition including visceral and subcutaneous adipose tissue will be estimated by DEXA.
Glycemic Control
Glycemic control will be assessed using oral glucose tolerance tests and hemoglobin A1c.
Insulin Resistance
Insulin resistance will be evaluated using the Homeostasis Assessment Model (HOMA) index.
Insulin Sensitivity
Insulin sensitivity will be assessed using the insulinogenic index, Stumvoll Metabolic Clearance Rate, Oral Glucose Insulin Sensitivity, and the Matsuda Index.

Secondary Outcome Measures

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.
Cognitive Function
Cognitive function will be evaluated using tasks that measure prefrontal cognitive control and hippocampal relational memory networks.
Retinal Lutein
Retinal lutein will be assessed using Macular Pigment Optical Density.
Serum Lutein
Serum lutein will be assessed using venous blood samples.
Blood Lipid Panel
Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides will be assessed using venous blood samples.
Resting Energy Expenditure
REE will be measured by indirect calorimetry.
Neuroelectric Assessment
A Neuroelectric Assessment will be conducted during cognitive tasks using an Electroencephalogram (EEG) amplifier.
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.
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.
Sleep and Fatigue
Sleep and fatigue will be evaluated using the Pittsburgh Sleep Quality Index
Physical Activity
Physical activity will be measured over 7 day periods by a waist mounted accelerometer.
Blood Pressure
Blood pressure will be measured using an automatic blood pressure cuff.
Liver Enzymes
Liver enzymes will be assessed using venous blood samples.
Inflammatory Markers
Markers of inflammation such as c-reactive protein (CRP) will be assessed using venous blood samples.

Full Information

First Posted
April 11, 2016
Last Updated
October 14, 2016
Sponsor
University of Illinois at Urbana-Champaign
Collaborators
Hass Avocado Board
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1. Study Identification

Unique Protocol Identification Number
NCT02740439
Brief Title
Persea Americana for Total Health (PATH ) Study
Acronym
PATH
Official Title
Investigating the Effects of Avocado Intake on Metabolism and Cognition: A Systems Approach
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
February 2019 (Anticipated)
Study Completion Date
February 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Illinois at Urbana-Champaign
Collaborators
Hass Avocado Board

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Abdominal, Insulin Resistance, Insulin Sensitivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Meal
Arm Type
Experimental
Arm Description
Intervention meals will contain 1 large avocado and be consumed daily for 12 weeks.
Arm Title
Control Meal
Arm Type
Placebo Comparator
Arm Description
Control meals will be isocaloric to the intervention meals but without avocado. They will also be consumed daily for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Avocado
Intervention Description
The intervention meals will contain 1 large avocado.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
The control meals will be isocaloric to the intervention meals but will not contain avocado.
Primary Outcome Measure Information:
Title
Abdominal obesity
Description
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
Title
Glycemic Control
Description
Glycemic control will be assessed using oral glucose tolerance tests and hemoglobin A1c.
Time Frame
Baseline, 4 weeks, 8 weeks,12 weeks
Title
Insulin Resistance
Description
Insulin resistance will be evaluated using the Homeostasis Assessment Model (HOMA) index.
Time Frame
Baseline, 4 weeks, 8 weeks, 12 weeks
Title
Insulin Sensitivity
Description
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 Outcome Measure Information:
Title
Gastrointestinal Microbiota Composition and Short Chain Fatty Acids
Description
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
Title
Cognitive Function
Description
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
Title
Retinal Lutein
Description
Retinal lutein will be assessed using Macular Pigment Optical Density.
Time Frame
Baseline, 4 weeks, 8 weeks, 12 weeks
Title
Serum Lutein
Description
Serum lutein will be assessed using venous blood samples.
Time Frame
Baseline, 12 weeks
Title
Blood Lipid Panel
Description
Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides will be assessed using venous blood samples.
Time Frame
Baseline, 12 weeks
Title
Resting Energy Expenditure
Description
REE will be measured by indirect calorimetry.
Time Frame
Baseline, 12 weeks
Title
Neuroelectric Assessment
Description
A Neuroelectric Assessment will be conducted during cognitive tasks using an Electroencephalogram (EEG) amplifier.
Time Frame
Baseline, 4 weeks, 8 weeks, 12 weeks
Title
DNA Analyses
Description
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
Title
Dietary Intake
Description
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
Title
Sleep and Fatigue
Description
Sleep and fatigue will be evaluated using the Pittsburgh Sleep Quality Index
Time Frame
Baseline, 12 weeks
Title
Physical Activity
Description
Physical activity will be measured over 7 day periods by a waist mounted accelerometer.
Time Frame
Baseline, 12 weeks
Title
Blood Pressure
Description
Blood pressure will be measured using an automatic blood pressure cuff.
Time Frame
Baseline, 12 weeks
Title
Liver Enzymes
Description
Liver enzymes will be assessed using venous blood samples.
Time Frame
Baseline, 12 weeks
Title
Inflammatory Markers
Description
Markers of inflammation such as c-reactive protein (CRP) will be assessed using venous blood samples.
Time Frame
Baseline, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hannah D Holscher, PhD RD
Phone
217-300-2512
Email
hholsche@illinois.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Naiman A Khan, PhD RD
Phone
217-300-2197
Email
nakhan@illinois.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hannah D Holscher, PhD RD
Organizational Affiliation
University of Illinois at Urbana-Champaign
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois, Urbana-Champaign
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ginger Reeser, MS, RD
Email
pathstudy@illinois.edu

12. IPD Sharing Statement

Citations:
PubMed Identifier
34191028
Citation
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.
Results Reference
derived
PubMed Identifier
32805028
Citation
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.
Results Reference
derived
PubMed Identifier
31846631
Citation
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.
Results Reference
derived
PubMed Identifier
30622502
Citation
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.
Results Reference
derived

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Persea Americana for Total Health (PATH ) Study

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