Persea Americana for Total Health (PATH)-2

NCT05941728 | Unknown

• 1 other identifier: 22788
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Keywords

Avocado; Gastrointestinal microbiome; Bile acid profile; Inflammation; Thinking; Glycemia

Outcome Measures

Primary Outcomes (4)

• Fecal microbial species

  Feacalibacterium spp., bacteria capable of producing SCFA and secondary bile acid synthesis measured using metagenomic sequencing

  4 weeks

• Fecal microbial genes

  Microbial genes involved in short-chain fatty acids and secondary bile acid synthesis measured using metagenomic sequencing

  4 weeks

• Concentration of fecal bile acids

  Fecal bile acid concentrations using HPLC in avocado and active comparator vs. control,

  4 weeks

• Concentration of fecal SCFA

  Fecal SCFA concentrations using GC-MS in avocado and active comparator vs. control,

  4 weeks

Secondary Outcomes (3)

• Cognitive function

  4 weeks

• Subjective gastrointestinal tolerance via questionnaire

  4 week

• Digestive health using stool records/Bristol Stool Scale

  4 week

Other Outcomes (5)

• Fecal microbiome

  4 weeks

• Inflammation

  4 weeks

• Intestinal permeability

  up to 4 weeks

Study Arms (3)

Avocado

EXPERIMENTAL

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

Other: Avocado

Fiber + Oil

ACTIVE COMPARATOR

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

Standard American Diet

SHAM COMPARATOR

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

Other: Average American Diet

Interventions

Avocado OTHER

The intervention treatment will contain avocado

Avocado

Oil + Fiber OTHER

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

Fiber + Oil

Average American Diet OTHER

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

Standard American Diet

Eligibility Criteria

• Age: 25 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 or corrected vision

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead

Study Sites (1)

University of Illinois, Urbana Champaign

Urbana, Illinois, 61801, United States

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity; Inflammation

Interventions

Oils; Dietary Fiber

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Lipids; Dietary Carbohydrates; Carbohydrates; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Hannah Holscher, PhD, RD

  University of Illinois Urbana Champaign

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hannah D Holscher, PhD, RD

CONTACT

217-300-2512; hholsche@illinois.edu

Maggie Oleksiak, MS

CONTACT

maggieo4@illinois.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: July 12, 2023
• Study Start: July 11, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: October 13, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)