Persea Americana for Total Health (PATH ) Study

Insulin Resistance Clinical Trial

— PATH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02740439
• Other study ID #: 16277
• Status: Recruiting
• Phase: N/A
• First received: April 11, 2016
• Last updated: October 14, 2016
• Start date: February 2016
• Est. completion date: February 2019

Study information

• Verified date: October 2016
• Source: University of Illinois at Urbana-Champaign
• Contact: Hannah D Holscher, PhD RD
• Phone: 217-300-2512
• Email: hholsche[@]illinois.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insulin Resistance
• Insulin Sensitivity
• Obesity, Abdominal

Intervention

Other:
• Avocado
The intervention meals will contain 1 large avocado.
• Control
The control meals will be isocaloric to the intervention meals but will not contain avocado.

Locations

Country	Name	City	State
United States	University of Illinois, Urbana-Champaign	Urbana	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign	Hass Avocado Board

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abdominal obesity	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	No
Primary	Glycemic Control	Glycemic control will be assessed using oral glucose tolerance tests and hemoglobin A1c.	Baseline, 4 weeks, 8 weeks,12 weeks	No
Primary	Insulin Resistance	Insulin resistance will be evaluated using the Homeostasis Assessment Model (HOMA) index.	Baseline, 4 weeks, 8 weeks, 12 weeks	No
Primary	Insulin Sensitivity	Insulin sensitivity will be assessed using the insulinogenic index, Stumvoll Metabolic Clearance Rate, Oral Glucose Insulin Sensitivity, and the Matsuda Index.	Baseline, 12 weeks	No
Secondary	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.	Baseline, 4 weeks, 8 weeks, 12 weeks	No
Secondary	Cognitive Function	Cognitive function will be evaluated using tasks that measure prefrontal cognitive control and hippocampal relational memory networks.	Baseline, 4 weeks, 8 weeks, 12 weeks	No
Secondary	Retinal Lutein	Retinal lutein will be assessed using Macular Pigment Optical Density.	Baseline, 4 weeks, 8 weeks, 12 weeks	No
Secondary	Serum Lutein	Serum lutein will be assessed using venous blood samples.	Baseline, 12 weeks	No
Secondary	Blood Lipid Panel	Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides will be assessed using venous blood samples.	Baseline, 12 weeks	No
Secondary	Resting Energy Expenditure	REE will be measured by indirect calorimetry.	Baseline, 12 weeks	No
Secondary	Neuroelectric Assessment	A Neuroelectric Assessment will be conducted during cognitive tasks using an Electroencephalogram (EEG) amplifier.	Baseline, 4 weeks, 8 weeks, 12 weeks	No
Secondary	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.	Baseline	No
Secondary	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.	Baseline, 4 weeks, 8 weeks, 12 weeks	No
Secondary	Sleep and Fatigue	Sleep and fatigue will be evaluated using the Pittsburgh Sleep Quality Index	Baseline, 12 weeks	No
Secondary	Physical Activity	Physical activity will be measured over 7 day periods by a waist mounted accelerometer.	Baseline, 12 weeks	No
Secondary	Blood Pressure	Blood pressure will be measured using an automatic blood pressure cuff.	Baseline, 12 weeks	No
Secondary	Liver Enzymes	Liver enzymes will be assessed using venous blood samples.	Baseline, 12 weeks	No
Secondary	Inflammatory Markers	Markers of inflammation such as c-reactive protein (CRP) will be assessed using venous blood samples.	Baseline, 12 weeks	No