Persea Americana for Total Health (PATH)-2
- Conditions
- Overweight and Obesity
- Interventions
- Other: AvocadoOther: Oil + FiberOther: Average American Diet
- Registration Number
- NCT05941728
- Lead Sponsor
- University of Illinois at Urbana-Champaign
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 45
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Avocado Avocado The experimental treatment will contain an avocado. Avocados will be consumed daily for 4 weeks. Fiber + Oil Oil + Fiber 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. Standard American Diet Average American Diet The sham comparator contains foods and beverages of a standard American diet and will be consumed daily for 4 weeks.
- Primary Outcome Measures
Name Time Method Concentration of fecal bile acids 4 weeks Fecal bile acid concentrations using HPLC in avocado and active comparator vs. control,
Fecal microbial genes 4 weeks Microbial genes involved in short-chain fatty acids and secondary bile acid synthesis measured using metagenomic sequencing
Fecal microbial species 4 weeks Feacalibacterium spp., bacteria capable of producing SCFA and secondary bile acid synthesis measured using metagenomic sequencing
Concentration of fecal SCFA 4 weeks Fecal SCFA concentrations using GC-MS in avocado and active comparator vs. control,
- Secondary Outcome Measures
Name Time Method Cognitive function 4 weeks Neuropshycological function as measured by a clinical cognitive task battery.
Subjective gastrointestinal tolerance via questionnaire 4 week 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 4 week Ratings of stool consistency using Bristol Stool Scale
Trial Locations
- Locations (1)
University of Illinois, Urbana Champaign
🇺🇸Urbana, Illinois, United States