Persea Americana for Total Health (PATH)-2
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Concentration of fecal bile acids
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 25 Years to 74 Years (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
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.
Intervention: Oil + Fiber (Other)
Standard American Diet
The sham comparator contains foods and beverages of a standard American diet and will be consumed daily for 4 weeks.
Intervention: Average American Diet (Other)
Avocado
The experimental treatment will contain an avocado. Avocados will be consumed daily for 4 weeks.
Intervention: Avocado (Other)
Outcomes
Primary Outcomes
Concentration of fecal bile acids
Time Frame: 4 weeks
Fecal bile acid concentrations using HPLC in avocado and active comparator vs. control,
Fecal microbial genes
Time Frame: 4 weeks
Microbial genes involved in short-chain fatty acids and secondary bile acid synthesis measured using metagenomic sequencing
Fecal microbial species
Time Frame: 4 weeks
Feacalibacterium spp., bacteria capable of producing SCFA and secondary bile acid synthesis measured using metagenomic sequencing
Concentration of fecal SCFA
Time Frame: 4 weeks
Fecal SCFA concentrations using GC-MS in avocado and active comparator vs. control,
Secondary Outcomes
- Subjective gastrointestinal tolerance via questionnaire(4 week)
- Cognitive function(4 weeks)
- Digestive health using stool records/Bristol Stool Scale(4 week)
Investigators
Hannah Holscher
Associate Professor
University of Illinois at Urbana-Champaign