Obesity, AbdominalPATHNCT02740439
Persea Americana for Total Health (PATH ) Study
A study testing Avocado in people with Obesity, Abdominal and Insulin Resistance, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
The proposed work will investigate the effects of avocados on abdominal obesity and glycemic control among overweight/obese adults. Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Abdominal, Insulin Resistance, Insulin Sensitivity
- What is being tested?
- Avocado
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Feb 2019
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females
- Between the ages of 25-45 years at the time of consent
- Body mass index ≥27.5kg/m2
- Normal or corrected-to-normal vision based on the minimal 20/20 standard in order to complete the cognitive task (below 20/20 vision).
- Ability to drop-off fecal sample within 15 minutes of defecation
Who cannot join
- Current pregnancy or lactation
- Tobacco use
- Avocado allergy or intolerance
- Food allergies, lactose intolerance
- Latex allergy
- Prior diagnosis of metabolic and gastrointestinal disease (cardiovascular disease and type 1 or type 2 diabetes, chronic constipation, diarrhea, Crohn's disease, celiac disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers, hepatitis, HIV, cancer, etc.)
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- Prior diagnosis of cognitive or physical disability, including ADHD, severe asthma, epilepsy, chronic kidney disease, and dependence upon a wheelchair/walking
- Use of any anti-psychotic, anti-depressant, anti-anxiety, or ADD/ADHD medications
- Use of medications that alter normal bowel function and metabolism (e.g., recent antibiotic use, laxatives, enemas, anti-diarrheal agents, narcotics, antacids, antispasmodics, diuretics, anticonvulsants).
- High BMI that is not representative of being overweight or obese (e.g. resistance trained individuals, football players)
- Prior malabsorptive bariatric surgery (i.e. gastric bypass, sleeve gastrectomy) or restrictive bariatric surgery (i.e. adjustable gastric band) within the past 2 years
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Illinois, Urbana-Champaign
Urbana, Illinois, 61801
Ginger Reeser, MS, RD, pathstudy@illinois.edu
About this study
Official title: Investigating the Effects of Avocado Intake on Metabolism and Cognition: A Systems Approach
The proposed work will investigate the effects of avocados on abdominal obesity and glycemic control among overweight/obese adults.
Read the detailed description
The proposed work will investigate the effects of avocados on abdominal obesity and glycemic control among overweight/obese adults. Further, changes in GI microbiota composition and cognitive function will be assessed to comprehensively understand systemic benefits of avocado consumption on gut and brain function. This research study has two aims: 1) To determine the effects of regular avocado intake on metabolic syndrome risk factors, specifically, abdominal obesity and glycemic control, among overweight and obese adults; and 2) to investigate the implications of avocado intake on measures of GI microbiota composition and cognitive function.
- Conditions
- Obesity, Abdominal, Insulin Resistance, Insulin Sensitivity
- Being tested
- Avocado, Control
- Medical subject headings
- Obesity, Abdominal, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvocadoOther
The intervention meals will contain 1 large avocado.
ControlOther
The control meals will be isocaloric to the intervention meals but will not contain avocado.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Meal | Experimental | Intervention meals will contain 1 large avocado and be consumed daily for 12 weeks. Receives: Other: Avocado |
| Control Meal | Placebo comparator | Control meals will be isocaloric to the intervention meals but without avocado. They will also be consumed daily for 12 weeks. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal obesity
Changes to abdominal and whole body composition including visceral and subcutaneous adipose tissue will be estimated by DEXA.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Glycemic Control
Glycemic control will be assessed using oral glucose tolerance tests and hemoglobin A1c.
Measured: Baseline, 4 weeks, 8 weeks,12 weeks
Insulin Resistance
Insulin resistance will be evaluated using the Homeostasis Assessment Model (HOMA) index.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Insulin Sensitivity
Insulin sensitivity will be assessed using the insulinogenic index, Stumvoll Metabolic Clearance Rate, Oral Glucose Insulin Sensitivity, and the Matsuda Index.
Measured: Baseline, 12 weeks
Secondary outcomes (14)
Gastrointestinal Microbiota Composition and Short Chain Fatty Acids
Microbial taxonomy will be assessed using high throughput sequencing and short chain fatty acids will be quantified using gas chromatography and mass spectrometry.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Cognitive Function
Cognitive function will be evaluated using tasks that measure prefrontal cognitive control and hippocampal relational memory networks.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Retinal Lutein
Retinal lutein will be assessed using Macular Pigment Optical Density.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Serum Lutein
Serum lutein will be assessed using venous blood samples.
Measured: Baseline, 12 weeks
Blood Lipid Panel
Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides will be assessed using venous blood samples.
Measured: Baseline, 12 weeks
Resting Energy Expenditure
REE will be measured by indirect calorimetry.
Measured: Baseline, 12 weeks
Neuroelectric Assessment
A Neuroelectric Assessment will be conducted during cognitive tasks using an Electroencephalogram (EEG) amplifier.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
DNA Analyses
Genetic markers related to obesity and cognitive function will be assessed using blood samples to determine the mediating effects of genetics on changes related to study outcomes.
Measured: Baseline
Dietary Intake
Dietary intake will be evaluated using 7 day diet records at baseline, 4, 8, and 12 weeks and by NCI NHANES 30-day food frequency questionnaires at baseline and 12 weeks.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Sleep and Fatigue
Sleep and fatigue will be evaluated using the Pittsburgh Sleep Quality Index
Measured: Baseline, 12 weeks
Physical Activity
Physical activity will be measured over 7 day periods by a waist mounted accelerometer.
Measured: Baseline, 12 weeks
Blood Pressure
Blood pressure will be measured using an automatic blood pressure cuff.
Measured: Baseline, 12 weeks
Liver Enzymes
Liver enzymes will be assessed using venous blood samples.
Measured: Baseline, 12 weeks
Inflammatory Markers
Markers of inflammation such as c-reactive protein (CRP) will be assessed using venous blood samples.
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startFeb 2016
- Primary completionFeb 2019 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Obesity, AbdominalStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- Hass Avocado Board
- Responsible party
- Sponsor
- Investigators
- Hannah D Holscher, PhD RD, Principal investigator, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02740439
- Sponsor's protocol ID
- 16277
- Acronym
- PATH
- Status last verified
- Oct 2016
- First submitted
- 11 Apr 2016
- Last updated
- 17 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Hughes RL, Pindus DM, Khan NA, Burd NA, Holscher HD. Associations between Accelerometer-Measured Physical Activity and Fecal Microbiota in Adults with Overweight and Obesity. Med Sci Sports Exerc. 2023 Apr 1;55(4):680-689. doi: 10.1249/MSS.0000000000003096. Epub 2022 Dec 22.
PubMed 36728974Khan NA, Edwards CG, Thompson SV, Hannon BA, Burke SK, Walk ADM, Mackenzie RWA, Reeser GE, Fiese BH, Burd NA, Holscher HD. Avocado Consumption, Abdominal Adiposity, and Oral Glucose Tolerance Among Persons with Overweight and Obesity. J Nutr. 2021 Sep 4;151(9):2513-2521. doi: 10.1093/jn/nxab187.
PubMed 34191028Thompson SV, Bailey MA, Taylor AM, Kaczmarek JL, Mysonhimer AR, Edwards CG, Reeser GE, Burd NA, Khan NA, Holscher HD. Avocado Consumption Alters Gastrointestinal Bacteria Abundance and Microbial Metabolite Concentrations among Adults with Overweight or Obesity: A Randomized Controlled Trial. J Nutr. 2021 Apr 8;151(4):753-762. doi: 10.1093/jn/nxaa219.
PubMed 32805028Edwards CG, Walk AM, Thompson SV, Reeser GE, Erdman JW Jr, Burd NA, Holscher HD, Khan NA. Effects of 12-week avocado consumption on cognitive function among adults with overweight and obesity. Int J Psychophysiol. 2020 Feb;148:13-24. doi: 10.1016/j.ijpsycho.2019.12.006. Epub 2019 Dec 14.
PubMed 31846631Jones AR, Robbs CM, Edwards CG, Walk AM, Thompson SV, Reeser GE, Holscher HD, Khan NA. Retinal Morphometric Markers of Crystallized and Fluid Intelligence Among Adults With Overweight and Obesity. Front Psychol. 2018 Dec 21;9:2650. doi: 10.3389/fpsyg.2018.02650. eCollection 2018.
PubMed 30622502
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Avocado Intake on Metabolism and Cognition: A Systems Approach
- ClinicalTrials.gov ID
- NCT02740439
- Acronym / sponsor ID
- PATH / 16277
- Conditions
- Obesity, Abdominal, Insulin Resistance, Insulin Sensitivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- Hass Avocado Board
- Study start
- Feb 2016
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 15 Apr 2016 (estimated)
- 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 proposed work will investigate the effects of avocados on abdominal obesity and glycemic control among overweight/obese adults.
Detailed description
The proposed work will investigate the effects of avocados on abdominal obesity and glycemic control among overweight/obese adults. Further, changes in GI microbiota composition and cognitive function will be assessed to comprehensively understand systemic benefits of avocado consumption on gut and brain function. This research study has two aims: 1) To determine the effects of regular avocado intake on metabolic syndrome risk factors, specifically, abdominal obesity and glycemic control, among overweight and obese adults; and 2) to investigate the implications of avocado intake on measures of GI microbiota composition and cognitive function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Meal | Experimental | Other: AvocadoIntervention meals will contain 1 large avocado and be consumed daily for 12 weeks. |
| Control Meal | Placebo comparator | Other: ControlControl meals will be isocaloric to the intervention meals but without avocado. They will also be consumed daily for 12 weeks. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Males and females
- Between the ages of 25-45 years at the time of consent
- Body mass index ≥27.5kg/m2
- Normal or corrected-to-normal vision based on the minimal 20/20 standard in order to complete the cognitive task (below 20/20 vision).
- Ability to drop-off fecal sample within 15 minutes of defecation
Key exclusion criteria (11 listed)
- Current pregnancy or lactation
- Tobacco use
- Avocado allergy or intolerance
- Food allergies, lactose intolerance
- Latex allergy
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 meals will contain 1 large avocado. | Other | Intervention Meal |
| ControlThe control meals will be isocaloric to the intervention meals but will not contain avocado. | Other | Control Meal |
Primary outcome
Abdominal obesity
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Changes to abdominal and whole body composition including visceral and subcutaneous adipose tissue will be estimated by DEXA.
Glycemic Control
Time frame: Baseline, 4 weeks, 8 weeks,12 weeks
Glycemic control will be assessed using oral glucose tolerance tests and hemoglobin A1c.
Insulin Resistance
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Insulin resistance will be evaluated using the Homeostasis Assessment Model (HOMA) index.
Insulin Sensitivity
Time frame: Baseline, 12 weeks
Insulin sensitivity will be assessed using the insulinogenic index, Stumvoll Metabolic Clearance Rate, Oral Glucose Insulin Sensitivity, and the Matsuda Index.
14 secondary outcomes
Gastrointestinal Microbiota Composition and Short Chain Fatty Acids
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Cognitive Function
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Retinal Lutein
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Serum Lutein
Time frame: Baseline, 12 weeks
Blood Lipid Panel
Time frame: Baseline, 12 weeks
Resting Energy Expenditure
Time frame: Baseline, 12 weeks
Neuroelectric Assessment
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
DNA Analyses
Time frame: Baseline
Dietary Intake
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Sleep and Fatigue
Time frame: Baseline, 12 weeks
Physical Activity
Time frame: Baseline, 12 weeks
Blood Pressure
Time frame: Baseline, 12 weeks
Liver Enzymes
Time frame: Baseline, 12 weeks
Inflammatory Markers
Time frame: Baseline, 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2016.
- Derived from this study: PubMed 36728974Hughes RL, Pindus DM, Khan NA, Burd NA, Holscher HD. Associations between Accelerometer-Measured Physical Activity and Fecal Microbiota in Adults with Overweight and Obesity. Med Sci Sports Exerc. 2023 Apr 1;55(4):680-689. doi: 10.1249/MSS.0000000000003096. Epub 2022 Dec 22.
- Derived from this study: PubMed 34191028Khan NA, Edwards CG, Thompson SV, Hannon BA, Burke SK, Walk ADM, Mackenzie RWA, Reeser GE, Fiese BH, Burd NA, Holscher HD. Avocado Consumption, Abdominal Adiposity, and Oral Glucose Tolerance Among Persons with Overweight and Obesity. J Nutr. 2021 Sep 4;151(9):2513-2521. doi: 10.1093/jn/nxab187.
- Derived from this study: PubMed 32805028Thompson SV, Bailey MA, Taylor AM, Kaczmarek JL, Mysonhimer AR, Edwards CG, Reeser GE, Burd NA, Khan NA, Holscher HD. Avocado Consumption Alters Gastrointestinal Bacteria Abundance and Microbial Metabolite Concentrations among Adults with Overweight or Obesity: A Randomized Controlled Trial. J Nutr. 2021 Apr 8;151(4):753-762. doi: 10.1093/jn/nxaa219.
- Derived from this study: PubMed 31846631Edwards CG, Walk AM, Thompson SV, Reeser GE, Erdman JW Jr, Burd NA, Holscher HD, Khan NA. Effects of 12-week avocado consumption on cognitive function among adults with overweight and obesity. Int J Psychophysiol. 2020 Feb;148:13-24. doi: 10.1016/j.ijpsycho.2019.12.006. Epub 2019 Dec 14.
- Derived from this study: PubMed 30622502Jones AR, Robbs CM, Edwards CG, Walk AM, Thompson SV, Reeser GE, Holscher HD, Khan NA. Retinal Morphometric Markers of Crystallized and Fluid Intelligence Among Adults With Overweight and Obesity. Front Psychol. 2018 Dec 21;9:2650. doi: 10.3389/fpsyg.2018.02650. eCollection 2018.
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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.
Hannah D Holscher, PhD RD principal investigator
University of Illinois at 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 in people with Obesity, Abdominal and Insulin Resistance, 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 5 inclusion and 11 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 17 Oct 2016. 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?
Abdominal obesity (time frame: Baseline, 4 weeks, 8 weeks, 12 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?
On the ClinicalTrials.gov record for NCT02740439, which also lists 5 linked publications.
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 17 Oct 2016.