Clinical trial NCT02740439: Persea Americana for Total Health (PATH ) Study
Official title: Investigating the Effects of Avocado Intake on Metabolism and Cognition: A Systems Approach
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity, Abdominal
Insulin Resistance
Insulin Sensitivity
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
Collaborators: name: Hass Avocado Board
First posted: 2016-04-15
Enrollment: 200
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Abdominal obesity
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Glycemic Control
timeFrame: Baseline, 4 weeks, 8 weeks,12 weeks
measure: Insulin Resistance
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Insulin Sensitivity
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Gastrointestinal Microbiota Composition and Short Chain Fatty Acids
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Cognitive Function
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Retinal Lutein
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Serum Lutein
timeFrame: Baseline, 12 weeks
measure: Blood Lipid Panel
timeFrame: Baseline, 12 weeks
measure: Resting Energy Expenditure
timeFrame: Baseline, 12 weeks
measure: Neuroelectric Assessment
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: DNA Analyses
timeFrame: Baseline
measure: Dietary Intake
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Sleep and Fatigue
timeFrame: Baseline, 12 weeks
measure: Physical Activity
timeFrame: Baseline, 12 weeks
measure: Blood Pressure
timeFrame: Baseline, 12 weeks
measure: Liver Enzymes
timeFrame: Baseline, 12 weeks
measure: Inflammatory Markers
timeFrame: Baseline, 12 weeks
Other outcomes:
Locations:
city: Urbana
country: United States
facility: University of Illinois, Urbana-Champaign
state: Illinois
Study officials:
affiliation: University of Illinois at Urbana-Champaign
name: Hannah D Holscher, PhD RD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.