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Persea Americana for Total Health (PATH ) Study

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02740439
Acronym
PATH
Enrollment
200
Registered
2016-04-15
Start date
2016-02-29
Completion date
2019-02-28
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Abdominal, Insulin Resistance, Insulin Sensitivity

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.

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.

Sponsors

Hass Avocado Board
CollaboratorOTHER
University of Illinois at Urbana-Champaign
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
25 Years to 45 Years
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Abdominal obesityBaseline, 4 weeks, 8 weeks, 12 weeksChanges to abdominal and whole body composition including visceral and subcutaneous adipose tissue will be estimated by DEXA.
Glycemic ControlBaseline, 4 weeks, 8 weeks,12 weeksGlycemic control will be assessed using oral glucose tolerance tests and hemoglobin A1c.
Insulin ResistanceBaseline, 4 weeks, 8 weeks, 12 weeksInsulin resistance will be evaluated using the Homeostasis Assessment Model (HOMA) index.
Insulin SensitivityBaseline, 12 weeksInsulin sensitivity will be assessed using the insulinogenic index, Stumvoll Metabolic Clearance Rate, Oral Glucose Insulin Sensitivity, and the Matsuda Index.

Secondary

MeasureTime frameDescription
Serum LuteinBaseline, 12 weeksSerum lutein will be assessed using venous blood samples.
Blood Lipid PanelBaseline, 12 weeksTotal cholesterol, HDL cholesterol, LDL cholesterol, triglycerides will be assessed using venous blood samples.
Resting Energy ExpenditureBaseline, 12 weeksREE will be measured by indirect calorimetry.
Neuroelectric AssessmentBaseline, 4 weeks, 8 weeks, 12 weeksA Neuroelectric Assessment will be conducted during cognitive tasks using an Electroencephalogram (EEG) amplifier.
Dietary IntakeBaseline, 4 weeks, 8 weeks, 12 weeksDietary 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.
DNA AnalysesBaselineGenetic 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.
Physical ActivityBaseline, 12 weeksPhysical activity will be measured over 7 day periods by a waist mounted accelerometer.
Blood PressureBaseline, 12 weeksBlood pressure will be measured using an automatic blood pressure cuff.
Liver EnzymesBaseline, 12 weeksLiver enzymes will be assessed using venous blood samples.
Inflammatory MarkersBaseline, 12 weeksMarkers of inflammation such as c-reactive protein (CRP) will be assessed using venous blood samples.
Sleep and FatigueBaseline, 12 weeksSleep and fatigue will be evaluated using the Pittsburgh Sleep Quality Index
Gastrointestinal Microbiota Composition and Short Chain Fatty AcidsBaseline, 4 weeks, 8 weeks, 12 weeksMicrobial taxonomy will be assessed using high throughput sequencing and short chain fatty acids will be quantified using gas chromatography and mass spectrometry.
Cognitive FunctionBaseline, 4 weeks, 8 weeks, 12 weeksCognitive function will be evaluated using tasks that measure prefrontal cognitive control and hippocampal relational memory networks.
Retinal LuteinBaseline, 4 weeks, 8 weeks, 12 weeksRetinal lutein will be assessed using Macular Pigment Optical Density.

Countries

United States

Contacts

Primary ContactHannah D Holscher, PhD RD
hholsche@illinois.edu217-300-2512
Backup ContactNaiman A Khan, PhD RD
nakhan@illinois.edu217-300-2197

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026