An interventional study of Avocado and Oil + Fiber in Overweight and Obesity, sponsored by University of Illinois at Urbana-Champaign. Status unknown at 1 site in United States. Open to participants aged 25 Years to 74 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-13.
Sponsored by University of Illinois at Urbana-Champaign · Not applicable, Interventional, and Basic science
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.
3,767 studies on the registry are indexed under Overweight; 863 are open to participants now.
This study's planned enrollment of 45 is below the median of 73 across 3,263 interventional studies indexed under Overweight.
Browse Overweight studies →University of Illinois at Urbana-Champaign is the lead sponsor of 191 studies on the registry; 29 are open to participants now.
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Exclusion Criteria:
The experimental treatment will contain an avocado. Avocados will be consumed daily for 4 weeks.
Other: Avocado
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
The sham comparator contains foods and beverages of a standard American diet and will be consumed daily for 4 weeks.
Other: Average American Diet
The intervention treatment will contain avocado
The active comparator will contain a snack with oils and fibers that mimic an avocado
The sham comparator will contain foods/beverages that mimic a standard American Diet
Fecal microbial species
Feacalibacterium spp., bacteria capable of producing SCFA and secondary bile acid synthesis measured using metagenomic sequencing
Time frame: 4 weeks
Fecal microbial genes
Microbial genes involved in short-chain fatty acids and secondary bile acid synthesis measured using metagenomic sequencing
Time frame: 4 weeks
Concentration of fecal bile acids
Fecal bile acid concentrations using HPLC in avocado and active comparator vs. control,
Time frame: 4 weeks
Concentration of fecal SCFA
Fecal SCFA concentrations using GC-MS in avocado and active comparator vs. control,
Time frame: 4 weeks
Cognitive function
Neuropshycological function as measured by a clinical cognitive task battery.
Time frame: 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
Time frame: 4 week
Digestive health using stool records/Bristol Stool Scale
Ratings of stool consistency using Bristol Stool Scale
Time frame: 4 week
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.
Time frame: 4 weeks
Inflammation
LPS-binding protein, a marker of inflammation will be measured using ELISA. (Blood samples)
Time frame: 4 weeks
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.
Time frame: up to 4 weeks
Fecal metabolites
Proteolytic metabolites will be measures in fecal samples using GC-MS
Time frame: 4 weeks
Fecal pH
Fecal pH will be measured using a pH meter
Time frame: 4 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2023 (actual). Primary completion is estimated for Jul 2024, 12 months after the start.
Of 1,356 non-industry interventional studies with no phase under Overweight, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 38. This study's planned 12 months is below that.
Counting every sponsor, half of 1,472 studies reached it within 17 months; a quarter within 7 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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University of Illinois at Urbana-Champaign →