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

Primary Purpose

Overweight and Obesity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Avocado
Oil + Fiber
Average American Diet
Sponsored by
University of Illinois at Urbana-Champaign
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Overweight and Obesity focused on measuring Avocado, Gastrointestinal microbiome, Bile acid profile, Inflammation, Thinking, Glycemia

Eligibility Criteria

25 Years - 74 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Illinois, Urbana ChampaignRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

Avocado

Fiber + Oil

Standard American Diet

Arm Description

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

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.

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

Outcomes

Primary Outcome Measures

Fecal microbial species
Feacalibacterium spp., bacteria capable of producing SCFA and secondary bile acid synthesis measured using metagenomic sequencing
Fecal microbial genes
Microbial genes involved in short-chain fatty acids and secondary bile acid synthesis measured using metagenomic sequencing
Concentration of fecal bile acids
Fecal bile acid concentrations using HPLC in avocado and active comparator vs. control,
Concentration of fecal SCFA
Fecal SCFA concentrations using GC-MS in avocado and active comparator vs. control,

Secondary Outcome Measures

Cognitive function
Neuropshycological function as measured by a clinical cognitive task battery.
Subjective gastrointestinal tolerance via questionnaire
Ratings of gastrointestinal symptoms (ease of stool passage, frequency of stools, abdominal pain, bloating, burping, flatulence, nausea, reflux, rumblings assessed using questionnaires
Digestive health using stool records/Bristol Stool Scale
Ratings of stool consistency using Bristol Stool Scale

Full Information

First Posted
June 27, 2023
Last Updated
October 11, 2023
Sponsor
University of Illinois at Urbana-Champaign
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1. Study Identification

Unique Protocol Identification Number
NCT05941728
Brief Title
Persea Americana for Total Health (PATH)-2
Acronym
PATH-2
Official Title
Persea Americana for Total Health (PATH)-2
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 11, 2023 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Urbana-Champaign

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
Avocado, Gastrointestinal microbiome, Bile acid profile, Inflammation, Thinking, Glycemia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Avocado
Arm Type
Experimental
Arm Description
The experimental treatment will contain an avocado. Avocados will be consumed daily for 4 weeks.
Arm Title
Fiber + Oil
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard American Diet
Arm Type
Sham Comparator
Arm Description
The sham comparator contains foods and beverages of a standard American diet and will be consumed daily for 4 weeks.
Intervention Type
Other
Intervention Name(s)
Avocado
Intervention Description
The intervention treatment will contain avocado
Intervention Type
Other
Intervention Name(s)
Oil + Fiber
Intervention Description
The active comparator will contain a snack with oils and fibers that mimic an avocado
Intervention Type
Other
Intervention Name(s)
Average American Diet
Intervention Description
The sham comparator will contain foods/beverages that mimic a standard American Diet
Primary Outcome Measure Information:
Title
Fecal microbial species
Description
Feacalibacterium spp., bacteria capable of producing SCFA and secondary bile acid synthesis measured using metagenomic sequencing
Time Frame
4 weeks
Title
Fecal microbial genes
Description
Microbial genes involved in short-chain fatty acids and secondary bile acid synthesis measured using metagenomic sequencing
Time Frame
4 weeks
Title
Concentration of fecal bile acids
Description
Fecal bile acid concentrations using HPLC in avocado and active comparator vs. control,
Time Frame
4 weeks
Title
Concentration of fecal SCFA
Description
Fecal SCFA concentrations using GC-MS in avocado and active comparator vs. control,
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Cognitive function
Description
Neuropshycological function as measured by a clinical cognitive task battery.
Time Frame
4 weeks
Title
Subjective gastrointestinal tolerance via questionnaire
Description
Ratings of gastrointestinal symptoms (ease of stool passage, frequency of stools, abdominal pain, bloating, burping, flatulence, nausea, reflux, rumblings assessed using questionnaires
Time Frame
4 week
Title
Digestive health using stool records/Bristol Stool Scale
Description
Ratings of stool consistency using Bristol Stool Scale
Time Frame
4 week
Other Pre-specified Outcome Measures:
Title
Fecal microbiome
Description
Relative abundance of microbial genes, genera, and community structure measured using metagenomic sequencing of extracted fecal DNA to compare abundances between avocado, active comparator, and control.
Time Frame
4 weeks
Title
Inflammation
Description
LPS-binding protein, a marker of inflammation will be measured using ELISA. (Blood samples)
Time Frame
4 weeks
Title
Intestinal permeability
Description
Intestinal permeability will be measured using a orally ingested sugar substitutes. 24-hour urinary appearance of the sugars will be quantified using GC-MS.
Time Frame
up to 4 weeks
Title
Fecal metabolites
Description
Proteolytic metabolites will be measures in fecal samples using GC-MS
Time Frame
4 weeks
Title
Fecal pH
Description
Fecal pH will be measured using a pH meter
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hannah D Holscher, PhD, RD
Phone
217-300-2512
Email
hholsche@illinois.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Maggie Oleksiak, MS
Email
maggieo4@illinois.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hannah Holscher, PhD, RD
Organizational Affiliation
University of Illinois Urbana Champaign
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois, Urbana Champaign
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maggie Oleksiak, MS
Email
maggieo4@illinois.edu
First Name & Middle Initial & Last Name & Degree
Hannah Holscher, PhD, RD
Email
hholsche@illinois.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Persea Americana for Total Health (PATH)-2

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