Persea Americana for Total Health (PATH)-2

NCT ID: NCT05941728

Last Updated: 2023-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-11

Study Completion Date

2024-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Avocado

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

Group Type EXPERIMENTAL

Avocado

Intervention Type OTHER

The intervention treatment will contain avocado

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.

Group Type ACTIVE_COMPARATOR

Oil + Fiber

Intervention Type OTHER

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

Standard American Diet

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

Group Type SHAM_COMPARATOR

Average American Diet

Intervention Type OTHER

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

Interventions

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Avocado

The intervention treatment will contain avocado

Intervention Type OTHER

Oil + Fiber

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

Intervention Type OTHER

Average American Diet

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Illinois at Urbana-Champaign

OTHER

Sponsor Role lead

Responsible Party

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Hannah Holscher

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hannah Holscher, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois Urbana Champaign

Locations

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University of Illinois, Urbana Champaign

Urbana, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Hannah D Holscher, PhD, RD

Role: CONTACT

217-300-2512

Maggie Oleksiak, MS

Role: CONTACT

Facility Contacts

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Maggie Oleksiak, MS

Role: primary

Hannah Holscher, PhD, RD

Role: backup

Other Identifiers

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22788

Identifier Type: -

Identifier Source: org_study_id

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