Persea Americana for Total Health (PATH)-2

Overweight and Obesity Clinical Trial

— PATH-2  

Official title:

Persea Americana for Total Health (PATH)-2

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05941728
• Other study ID #: 22788
• Status: Recruiting
• Phase: N/A
• Start date: July 11, 2023
• Est. completion date: July 2024

Study information

• Verified date: October 2023
• Source: University of Illinois at Urbana-Champaign
• Contact: Hannah D Holscher, PhD, RD
• Phone: 217-300-2512
• Email: hholsche[@]illinois.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Other:
• Avocado
The intervention treatment will contain avocado
• Oil + Fiber
The active comparator will contain a snack with oils and fibers that mimic an avocado
• Average American Diet
The sham comparator will contain foods/beverages that mimic a standard American Diet

Locations

Country	Name	City	State
United States	University of Illinois, Urbana Champaign	Urbana	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fecal microbiome	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.	4 weeks
Other	Inflammation	LPS-binding protein, a marker of inflammation will be measured using ELISA. (Blood samples)	4 weeks
Other	Intestinal permeability	Intestinal permeability will be measured using a orally ingested sugar substitutes. 24-hour urinary appearance of the sugars will be quantified using GC-MS.	up to 4 weeks
Other	Fecal metabolites	Proteolytic metabolites will be measures in fecal samples using GC-MS	4 weeks
Other	Fecal pH	Fecal pH will be measured using a pH meter	4 weeks
Primary	Fecal microbial species	Feacalibacterium spp., bacteria capable of producing SCFA and secondary bile acid synthesis measured using metagenomic sequencing	4 weeks
Primary	Fecal microbial genes	Microbial genes involved in short-chain fatty acids and secondary bile acid synthesis measured using metagenomic sequencing	4 weeks
Primary	Concentration of fecal bile acids	Fecal bile acid concentrations using HPLC in avocado and active comparator vs. control,	4 weeks
Primary	Concentration of fecal SCFA	Fecal SCFA concentrations using GC-MS in avocado and active comparator vs. control,	4 weeks
Secondary	Cognitive function	Neuropshycological function as measured by a clinical cognitive task battery.	4 weeks
Secondary	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
Secondary	Digestive health using stool records/Bristol Stool Scale	Ratings of stool consistency using Bristol Stool Scale	4 week