Persea Americana for Total Health (PATH)-2

Study Overview
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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.

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

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Other: Avocado
* Other: Oil + Fiber
* Other: Average American Diet


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Avocado<br>The experimental treatment will contain an avocado. Avocados will be consumed daily for 4 weeks. | Other: Avocado<br>* The intervention treatment will contain avocado<br>|
| Active Comparator: Fiber + Oil<br>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<br>* The active comparator will contain a snack with oils and fibers that mimic an avocado<br>|
| Sham Comparator: Standard American Diet<br>The sham comparator contains foods and beverages of a standard American diet and will be consumed daily for 4 weeks. | Other: Average American Diet<br>* The sham comparator will contain foods/beverages that mimic a standard American Diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive function | Neuropshycological function as measured by a clinical cognitive task battery. | 4 weeks | 
| 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 | 4 week | 
| Digestive health using stool records/Bristol Stool Scale | Ratings of stool consistency using Bristol Stool Scale | 4 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Avocado, Gastrointestinal microbiome, Bile acid profile, Inflammation, Thinking, Glycemia