Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2026-03-06 @ 12:34 AM
Study NCT ID:
NCT05941728
Status:
UNKNOWN
Last Update Posted:
2023-10-13
First Post:
2023-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Persea Americana for Total Health (PATH)-2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009821', 'term': 'Oils'}, {'id': 'D004043', 'term': 'Dietary Fiber'}], 'ancestors': [{'id': 'D008055', 'term': 'Lipids'}, {'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-11', 'studyFirstSubmitDate': '2023-06-27', 'studyFirstSubmitQcDate': '2023-07-11', 'lastUpdatePostDateStruct': {'date': '2023-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Fecal microbiome', 'timeFrame': '4 weeks', 'description': '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.'}, {'measure': 'Inflammation', 'timeFrame': '4 weeks', 'description': 'LPS-binding protein, a marker of inflammation will be measured using ELISA. (Blood samples)'}, {'measure': 'Intestinal permeability', 'timeFrame': 'up to 4 weeks', 'description': 'Intestinal permeability will be measured using a orally ingested sugar substitutes. 24-hour urinary appearance of the sugars will be quantified using GC-MS.'}, {'measure': 'Fecal metabolites', 'timeFrame': '4 weeks', 'description': 'Proteolytic metabolites will be measures in fecal samples using GC-MS'}, {'measure': 'Fecal pH', 'timeFrame': '4 weeks', 'description': 'Fecal pH will be measured using a pH meter'}], 'primaryOutcomes': [{'measure': 'Fecal microbial species', 'timeFrame': '4 weeks', 'description': 'Feacalibacterium spp., bacteria capable of producing SCFA and secondary bile acid synthesis measured using metagenomic sequencing'}, {'measure': 'Fecal microbial genes', 'timeFrame': '4 weeks', 'description': 'Microbial genes involved in short-chain fatty acids and secondary bile acid synthesis measured using metagenomic sequencing'}, {'measure': 'Concentration of fecal bile acids', 'timeFrame': '4 weeks', 'description': 'Fecal bile acid concentrations using HPLC in avocado and active comparator vs. control,'}, {'measure': 'Concentration of fecal SCFA', 'timeFrame': '4 weeks', 'description': 'Fecal SCFA concentrations using GC-MS in avocado and active comparator vs. control,'}], 'secondaryOutcomes': [{'measure': 'Cognitive function', 'timeFrame': '4 weeks', 'description': 'Neuropshycological function as measured by a clinical cognitive task battery.'}, {'measure': 'Subjective gastrointestinal tolerance via questionnaire', 'timeFrame': '4 week', 'description': 'Ratings of gastrointestinal symptoms (ease of stool passage, frequency of stools, abdominal pain, bloating, burping, flatulence, nausea, reflux, rumblings assessed using questionnaires'}, {'measure': 'Digestive health using stool records/Bristol Stool Scale', 'timeFrame': '4 week', 'description': 'Ratings of stool consistency using Bristol Stool Scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Avocado', 'Gastrointestinal microbiome', 'Bile acid profile', 'Inflammation', 'Thinking', 'Glycemia'], 'conditions': ['Overweight and Obesity']}, 'descriptionModule': {'briefSummary': '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:\n\nHow 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants must be between the ages of 25 and 74 years old\n* BMI ≥ 25 kg/m2\n* Ability to drop off fecal sample within 15 minutes of defecation\n* 20/20 or corrected vision\n\nExclusion Criteria:\n\n* Avocado allergy or intolerance\n* Food allergies or intolerances\n* 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\n* Women that are pregnant, have given birth in the previous 12 months or are lactating\n* Individuals that smoke, use tobacco, abuse drugs, or consume \\> 2 alcoholic beverages per day.\n* \\> 5% weight change in the past month or \\> 10% change in the past six months\n* Oral antibiotics during the previous 6 weeks.\n* Currently taking lipid-lowering medications, oral hypoglycemic agents, or insulin.\n* History of malabsorptive or restrictive bariatric surgeries (e.g., gastric bypass, sleeve gastrectomy, adjustable gastric band) or gall bladder removal surgery.\n* Are unable to consume the experimental meals/snacks.\n* Allergic to latex\n* Concurrent enrollment in another dietary, exercise, or medication study"}, 'identificationModule': {'nctId': 'NCT05941728', 'acronym': 'PATH-2', 'briefTitle': 'Persea Americana for Total Health (PATH)-2', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Urbana-Champaign'}, 'officialTitle': 'Persea Americana for Total Health (PATH)-2', 'orgStudyIdInfo': {'id': '22788'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Avocado', 'description': 'The experimental treatment will contain an avocado. Avocados will be consumed daily for 4 weeks.', 'interventionNames': ['Other: Avocado']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fiber + Oil', 'description': '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.', 'interventionNames': ['Other: Oil + Fiber']}, {'type': 'SHAM_COMPARATOR', 'label': 'Standard American Diet', 'description': 'The sham comparator contains foods and beverages of a standard American diet and will be consumed daily for 4 weeks.', 'interventionNames': ['Other: Average American Diet']}], 'interventions': [{'name': 'Avocado', 'type': 'OTHER', 'description': 'The intervention treatment will contain avocado', 'armGroupLabels': ['Avocado']}, {'name': 'Oil + Fiber', 'type': 'OTHER', 'description': 'The active comparator will contain a snack with oils and fibers that mimic an avocado', 'armGroupLabels': ['Fiber + Oil']}, {'name': 'Average American Diet', 'type': 'OTHER', 'description': 'The sham comparator will contain foods/beverages that mimic a standard American Diet', 'armGroupLabels': ['Standard American Diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61801', 'city': 'Urbana', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Maggie Oleksiak, MS', 'role': 'CONTACT', 'email': 'maggieo4@illinois.edu'}, {'name': 'Hannah Holscher, PhD, RD', 'role': 'CONTACT', 'email': 'hholsche@illinois.edu'}], 'facility': 'University of Illinois, Urbana Champaign', 'geoPoint': {'lat': 40.11059, 'lon': -88.20727}}], 'centralContacts': [{'name': 'Hannah D Holscher, PhD, RD', 'role': 'CONTACT', 'email': 'hholsche@illinois.edu', 'phone': '217-300-2512'}, {'name': 'Maggie Oleksiak, MS', 'role': 'CONTACT', 'email': 'maggieo4@illinois.edu'}], 'overallOfficials': [{'name': 'Hannah Holscher, PhD, RD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Illinois Urbana Champaign'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Urbana-Champaign', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Hannah Holscher', 'investigatorAffiliation': 'University of Illinois at Urbana-Champaign'}}}}