PATH-2: Persea Americana for Total Health (PATH)-2

Sponsor

University of Illinois at Urbana-Champaign (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05941728

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The goal of this clinical trial is to learn about the effects of avocado consumption on gastrointestinal health in adults with overweight and obesity. The main questions is aims to answer are:

How does avocado consumption affect the gut microbiome? How does avocado consumption affect thinking? Are there connections between the microbiome and cognition? Participants will be asked to eat provided meals with and without avocados for three 4-week periods. At the end of each 4-week period, participants will be asked to provide stool samples and complete computer games that assess thinking and memory.

Condition or Disease	Intervention/Treatment	Phase
Overweight and Obesity	Other: Avocado Other: Oil + Fiber Other: Average American Diet	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Investigator)

Primary Purpose:

Basic Science

Official Title:

Persea Americana for Total Health (PATH)-2

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Avocado The experimental treatment will contain an avocado. Avocados will be consumed daily for 4 weeks.	Other: Avocado The intervention treatment will contain avocado
Active Comparator: Fiber + Oil The active comparator will have a snack that mimics the fiber and fatty acid composition found in avocados and will be consumed daily for 4 weeks.	Other: Oil + Fiber The active comparator will contain a snack with oils and fibers that mimic an avocado
Sham Comparator: Standard American Diet The sham comparator contains foods and beverages of a standard American diet and will be consumed daily for 4 weeks.	Other: Average American Diet The sham comparator will contain foods/beverages that mimic a standard American Diet

Arm

Intervention/Treatment

Experimental: Avocado

The experimental treatment will contain an avocado. Avocados will be consumed daily for 4 weeks.

Other: Avocado

The intervention treatment will contain avocado

Active Comparator: Fiber + Oil

The active comparator will have a snack that mimics the fiber and fatty acid composition found in avocados and will be consumed daily for 4 weeks.

Other: Oil + Fiber

The active comparator will contain a snack with oils and fibers that mimic an avocado

Sham Comparator: Standard American Diet

The sham comparator contains foods and beverages of a standard American diet and will be consumed daily for 4 weeks.

Other: Average American Diet

The sham comparator will contain foods/beverages that mimic a standard American Diet

Outcome Measures

Primary Outcome Measures

Fecal microbial species [4 weeks]
Feacalibacterium spp. measured using metagenomic sequencing
Concentration of fecal bile acids [4 weeks]
Fecal bile acid concentrations using HPLC in avocado and active comparator vs. control,
Concentration of fecal SCFA [4 weeks]
Fecal SCFA concentrations using GC-MS in avocado and active comparator vs. control,

Secondary Outcome Measures

Cognitive function [4 weeks]
Neuropshycological function as measured by a clinical cognitive task battery.

Other Outcome Measures

Fecal microbiome [4 weeks]
Relative abundance of microbial genes and genera measured using metagenomic sequencing of extracted fecal DNA to compare abundances between avocado, active comparator, and control.
Inflammation [4 weeks]
LPS-binding protein, a marker of inflammation will be measured using ELISA. (Blood samples)
Intestinal permeability [up to 4 weeks]
Intestinal permeability will be measured using a orally ingested sugar substitutes. 24-hour urinary appearance of the sugars will be quantified using GC-MS.
Fecal metabolites [4 weeks]
Proteolytic metabolites will be measures in fecal samples using GC-MS

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 74 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Participants must be between the ages of 25 and 74 years old
BMI ≥ 25 kg/m2
Ability to drop off fecal sample within 15 minutes of defecation
20/20 or corrected vision

Exclusion Criteria:

Avocado allergy or intolerance
Food allergies or intolerances
Prior diagnosis of liver or gastrointestinal disease (primary biliary cirrhosis or gallbladder disease, chronic constipation, diarrhea, Crohn's disease, celiac disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers), diabetes, hepatitis, HIV, or cancer
Women that are pregnant, have given birth in the previous 12 months or are lactating
Individuals that smoke, use tobacco, abuse drugs, or consume > 2 alcoholic beverages per day.
5% weight change in the past month or > 10% change in the past six months
Oral antibiotics during the previous 6 weeks.
Currently taking lipid-lowering medications, oral hypoglycemic agents, or insulin.
History of malabsorptive or restrictive bariatric surgeries (e.g., gastric bypass, sleeve gastrectomy, adjustable gastric band) or gall bladder removal surgery.
Are unable to consume the experimental meals/snacks.
Allergic to latex
Concurrent enrollment in another dietary, exercise, or medication study