Overweight and ObesityPATH-2NCT05941728
Persea Americana for Total Health (PATH)-2
A study testing Avocado, Oil + Fiber and Average American Diet in people with Overweight and Obesity, run by University of Illinois at Urbana-Champaign at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 25 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Avocado, Oil + Fiber and Average American Diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2023to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Maggie Oleksiak, MS contact
United States1 site, 1 recruiting
- Recruiting
University of Illinois, Urbana Champaign
Urbana, Illinois, 61801
Maggie Oleksiak, MS, maggieo4@illinois.edu
Hannah Holscher, PhD, RD, hholsche@illinois.edu
About this study
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.
- Conditions
- Overweight and Obesity
- Being tested
- Avocado, Oil + Fiber, Average American Diet
- Keywords
- Avocado, Gastrointestinal microbiome, Bile acid profile, Inflammation, Thinking, Glycemia
- Medical subject headings
- Overweight, Obesity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvocadoOther
The intervention treatment will contain avocado
Oil + FiberOther
The active comparator will contain a snack with oils and fibers that mimic an avocado
Average American DietOther
The sham comparator will contain foods/beverages that mimic a standard American Diet
| Study group | Role | What they receive |
|---|---|---|
| Avocado | Experimental | The experimental treatment will contain an avocado. Avocados will be consumed daily for 4 weeks. Receives: Other: Avocado |
| Fiber + Oil | Active comparator | 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. Receives: Other: Oil + Fiber |
| Standard American Diet | Sham comparator | The sham comparator contains foods and beverages of a standard American diet and will be consumed daily for 4 weeks. Receives: Other: Average American Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal microbial species
Feacalibacterium spp., bacteria capable of producing SCFA and secondary bile acid synthesis measured using metagenomic sequencing
Measured: 4 weeks
Fecal microbial genes
Microbial genes involved in short-chain fatty acids and secondary bile acid synthesis measured using metagenomic sequencing
Measured: 4 weeks
Concentration of fecal bile acids
Fecal bile acid concentrations using HPLC in avocado and active comparator vs. control,
Measured: 4 weeks
Concentration of fecal SCFA
Fecal SCFA concentrations using GC-MS in avocado and active comparator vs. control,
Measured: 4 weeks
Secondary outcomes (3)
Cognitive function
Neuropshycological function as measured by a clinical cognitive task battery.
Measured: 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
Measured: 4 week
Digestive health using stool records/Bristol Stool Scale
Ratings of stool consistency using Bristol Stool Scale
Measured: 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start11 Jul 2023
- Primary completionJul 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hannah Holscher, University of Illinois at Urbana-Champaign
- Investigators
- Hannah Holscher, PhD, RD, Principal investigator, University of Illinois Urbana Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05941728
- Sponsor's protocol ID
- 22788
- Acronym
- PATH-2
- Status last verified
- Oct 2023
- First submitted
- 27 Jun 2023
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persea Americana for Total Health (PATH)-2
- ClinicalTrials.gov ID
- NCT05941728
- Acronym / sponsor ID
- PATH-2 / 22788
- Conditions
- Overweight and Obesity
- Keywords
- Avocado, Gastrointestinal microbiome, Bile acid profile, Inflammation, Thinking, Glycemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- 11 Jul 2023 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 12 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Avocado | Experimental | Other: AvocadoThe experimental treatment will contain an avocado. Avocados will be consumed daily for 4 weeks. |
| Fiber + Oil | Active comparator | Other: Oil + FiberThe 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 | Sham comparator | Other: Average American DietThe sham comparator contains foods and beverages of a standard American diet and will be consumed daily for 4 weeks. |
Who may qualify
- Ages
- 25 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AvocadoThe intervention treatment will contain avocado | Other | Avocado |
| Oil + FiberThe active comparator will contain a snack with oils and fibers that mimic an avocado | Other | Fiber + Oil |
| Average American DietThe sham comparator will contain foods/beverages that mimic a standard American Diet | Other | Standard American Diet |
Primary outcome
Fecal microbial species
Time frame: 4 weeks
Feacalibacterium spp., bacteria capable of producing SCFA and secondary bile acid synthesis measured using metagenomic sequencing
Fecal microbial genes
Time frame: 4 weeks
Microbial genes involved in short-chain fatty acids and secondary bile acid synthesis measured using metagenomic sequencing
Concentration of fecal bile acids
Time frame: 4 weeks
Fecal bile acid concentrations using HPLC in avocado and active comparator vs. control,
Concentration of fecal SCFA
Time frame: 4 weeks
Fecal SCFA concentrations using GC-MS in avocado and active comparator vs. control,
3 secondary outcomes
Cognitive function
Time frame: 4 weeks
Subjective gastrointestinal tolerance via questionnaire
Time frame: 4 week
Digestive health using stool records/Bristol Stool Scale
Time frame: 4 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maggie Oleksiak, MS contact
Hannah Holscher, PhD, RD principal investigator
University of Illinois Urbana Champaign
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Avocado, Oil + Fiber and Average American Diet in people with Overweight and Obesity, run by University of Illinois at Urbana-Champaign at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hannah D Holscher, PhD, RD (217-300-2512, hholsche@illinois.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fecal microbial species (time frame: 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2023.