PrediabetesFAMNCT07624500
Food and Metabolism Study
A study testing Avocado meal plan in people with Prediabetes and Insulin Resistance, run by Clinical Nutrition Research Center, Illinois Institute of Technology at 1 site in United States.
Trial summary
In this study, Investigators are interested in looking at the influence of eating avocados regularly, which are rich in healthy fats, fibers, and unique carbohydrates, on triglyceride and glucose metabolism in people with prediabetes and insulin resistance. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Prediabetes, Insulin Resistance, Triglycerides
- What is being tested?
- Avocado meal plan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men or women, 40-70 years of age.
- Fasting triglycerides (TG) >115 mg/dL.
- Insulin resistance as measured by Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) >2.5.
- Able to provide informed consent.
- Able to comply with and perform the procedures requested by the protocol, specifically eat all the meals and snacks provided by the study which will be almost all your food (~ 80% of calories per day).
- Able to come to the clinic up to 6 times during the study.
- Able to maintain usual physical activity pattern.
- Able to avoid/abstain from alcohol and vigorous physical activity for 24 hours prior to and during study visit.
Who cannot join
- Men and women with known or suspected intolerance, allergies or hypersensitivity to study foods or interventions.
- Fasting blood sugar ≥125 mg/dL. Men and women with blood pressure >160 mmHg (systolic) / 100 mmHg (diastolic) at the screening visit.
- Men and women with history of diabetes cardiovascular events, respiratory, renal, gastrointestinal, hepatic or eye disease or surgery- within a year.
- Men and women who have or had cancer other than non-melanoma skin cancer in the past 5 years.
- Men and women taking over the counter or prescription medications or dietary supplements that may interfere with study procedures or endpoints.
- Men and women who are on a specialized diet (vegan, vegetarian, keto, etc.). - - Men and women who consume nuts or peanuts daily or most days of the week.
Show all 16Show fewer
- Men and women who are not weight stable (+/-10lbs in previous 2 months). Men and women who have excessive use of drugs or alcohol (ie., addictions) within the past 2 years.
- Men and women with documented physical or mental disease/condition, which might limit participation in or completion of the study or, that, in the opinion of the investigator, could interfere with the interpretation of the study results.
- Women who are known to be pregnant or who are intending to become pregnant over the course of the study.
- Women who are lactating.
- Major trauma or a surgical event within 2 months (or longer depending on trauma or event) and after consultation with PI. Has used antibiotics within the previous 2 months.
- History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional.
- Excessive coffee and tea consumers (> 4 cups/d).
- Donated blood within the last 3 months.
- Women who are taking an unstable dose and brand of hormonal contraceptives and/or a stable dose and brand for less than 6 months.
- Unusual working hours (working overnight).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Clinical Nutrition Research Center at IIT
Chicago, Illinois, 60616
About this study
Official title: Effects of Avocado on Triglyceride Metabolism in Individuals With Insulin Resistance
In this study, Investigators are interested in looking at the influence of eating avocados regularly, which are rich in healthy fats, fibers, and unique carbohydrates, on triglyceride and glucose metabolism in people with prediabetes and insulin resistance.
Read the detailed description
The proposed study will be conducted in humans according to Good Clinical Practice (GCP) guidelines. All subjects will review and sign an Informed Consent Form approved by the Illinois Institute of Technology's Institutional Review Boards (IRB) prior to screening. The research is designed as a randomized, 2-arm, parallel, diet-controlled, human clinical trial to investigate the effects of avocado consumption for 4 weeks on triglyceride metabolism in individuals with insulin resistance.
Participants will be asked to do the items described below. Visits will be held at the Clinical Nutrition Research Center (CNRC) on the Illinois Tech Campus, 10 W. 35th St., Suite 3D6-1 Chicago, IL, 60616.
SCREENING VISIT
Eligibility for the study is based on the above list (inclusion and exclusion criteria). Investigators will determine if participants qualify for the study at the Screening Visit by the following measurements:
- General measurements: height, weight, body composition, waist circumference, blood pressure, vitals and body temperature
- Fasting blood glucose (sugar) from a finger prick
- Venous blood collection to assess blood glucose, insulin, and triglycerides
- Pregnancy test, for women under the age of 60
Demographic questionnaire, health and medication questionnaire: participants will be asked to provide personal information, such as their name, date of birth, race, etc. Investigators will also ask them to answer questions about their demographics, health, medical history, and the medications they are taking. Based on the results of the blood draw, questionnaires, measurements, and evaluation of their health, they may meet the criteria and be invited to participate in the study.
PRE-STUDY / PRE-INTERVENTION VISIT (which may be performed on the same or a different day as the screening visit) The Pre-Study visit lasts ~45 minutes to 1 hour and participants will meet with one of our investigators who will provide detailed instructions on procedures of the study and "how to prepare for each of participants study days." They will be trained in all study procedures, including, but not limited to, foods to avoid during the study, medications/supplements to avoid, food diary recording, gastrointestinal diary recording and fasting overnight. Their study dates will be scheduled, and they will be provided with a study booklet, including a study calendar and all instructions covered at the Pre-Study Visit.
Medications/Supplements: If they are taking any medications or supplements that do not interfere with the study or have been OK'd by study staff, they will take those as instructed by their doctor and will record them in their diary. Investigators will train the participants on what foods or supplements are OK and NOT OK during the study at the Pre-Study Visit.
Self-Characteristics and Dietary Surveys: Participants will be asked to complete online surveys that cover usual gastrointestinal symptoms and a 24-hour food recall (https://asa24.nih.gov/).
STUDY DAY VISITS Study Visit 1 / Day 0 and Visit 5 / Day 28 Procedures
Staff collects study materials from the participant
- Diary and provide 24 h recall (https://asa24.nih.gov/) Confirmation participant is ready to go for their study day by interview/discussion with the study staff
- Fasted overnight for 10-12 hours, including finger prick to verify usual fasting glucose
- Had a usual night of sleep (5-6 hours minimum)
- Avoided alcohol and vigorous physical activity 24 hours before the study day
After confirming they are ready for their study day, Investigators will proceed to an exam room to measure:
Anthropometrics: Investigators will measure weight, waist circumference and body composition.
Vital signs: Investigators will check their blood pressure, heart rate, and body temperature using standard clinic devices.
Once Investigators have collected measurements, they will proceed with an IV catheter to collect blood over multiple timepoints.
Blood collection: Participants will see the Licensed Health Care Provider (LHCP) for blood sample collection. Investigators will use an indwelling catheter (IV). This means Investigators will use a needle to put a thin tube in their arm or hand, from which Investigators can get blood samples while keeping them as comfortable as possible. This tube will stay in their arm until all blood drawings are completed during their visit. If there is difficulty with blood flow Investigators will ask the participant if they're comfortable with single stick blood collection, performed by LHCP using a butterfly needle. There will be nine blood draws in total over 5 hours.
Once the fasting blood draw is collected, Investigators will provide the participant with a breakfast in the form of a nutritionally complete liquid meal test (LMT).
Standard Liquid Meal Test (LMT): For this test, they will drink about 2 cups of vanilla flavored Ensure®. Ensure® is a nutritional supplement containing a mixture of sugars, fats, and protein and a variety of vitamins and minerals. The drink contains milk protein (suitable for lactose intolerance) and soy products. Investigators will ask if they are unwilling to consume any ingredients in the Ensure® drink. It may be unsafe for them to complete this test if they have an allergy to any of the components. The total amount participant will drink will be approximately 440 calories, 64g of Carbs, 12g of Fat, and 18g of Protein.
After all blood samples have been collected they will be provided with meals to last until V2 (~ 1 week) and instructed how to fill out the dietary adherence log.
MEAL PICKUP VISITS Study Visit 2 / Day 7, Study Visit 3 / Day 14, Study Visit 4 / Day 21
Participants will not need to come fasted for meal pickup visits. Investigators will collect materials and ensure they are complying with the study protocols, and assess if there are any difficulties Investigators can help with. The following will be done at pickup visits:
Staff collects study materials from the participant 1. Diary and provide 24 h recall (https://asa24.nih.gov/) Staff collects weight and LDN does counseling as needed
- Licensed Dietitian Nutritionist (LDN) will review compliance diary and weight changes and provide nutrition counseling as needed
- Conditions
- Prediabetes, Insulin Resistance, Triglycerides, Lipids Metabolism
- Being tested
- Avocado meal plan, Control meal plan
- Keywords
- Triglycerides, Insulin resistance, Glucose metabolism, Lipids metabolism
- Medical subject headings
- Prediabetic State, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avocado meal planOther
American Diet with avocado
Control meal planOther
American diet
| Study group | Role | What they receive |
|---|---|---|
| Avocado meal plan | Active comparator | 2 meals and snack per day including one avocado in the meal, covering 80% of daily calories need. Receives: Other: Avocado meal plan |
| Control meal plan | Placebo comparator | 2 meals and snacks per day without the inclusion of avocado, covering 80% of daily calories needs. Receives: Other: Control meal plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in serum biomarker: triglycerides
analyzed by McLendon labs
Measured: baseline and 4 weeks
Secondary outcomes (16)
Changes in serum biomarker: insulin
analyzed by McLendon labs
Measured: baseline and 4 weeks
Changes in serum biomarker: glucose
analyzed by McLendon labs
Measured: baseline and 4 weeks
Changes in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Calculated from fasting glucose and insulin
Measured: baseline and 4 weeks
Changes in Muscle Insulin Sensitivity Index (MISI)
calculated using postprandial glucose and insulin concentrations measured by Randox clinical analyzer
Measured: baseline and 4 weeks
Changes in total cholesterol
fasting state, analyzed by Labcorp
Measured: baseline and 4 weeks
Changes in Low-Density Lipoprotein (LDL) cholesterol
fasting state, analyzed by Labcorp
Measured: baseline and 4 weeks
Changes in High-Density Lipoprotein (HDL) cholesterol
fasting state, analyzed by Labcorp
Measured: baseline and 4 weeks
Changes in non-High-Density Lipoprotein (HDL) cholesterol
fasting state, analyzed by Labcorp
Measured: baseline and 4 weeks
Changes in Connecting Peptide (C-peptide)
analyzed by McLendon labs
Measured: baseline and 4 weeks
Changes in free fatty acids
analyzed by Quest Diagnostics Lab
Measured: baseline and 4 weeks
Changes in Glucagon-Like Peptide-1(GLP-1)
analyzed by Luminex multi-target analyzer
Measured: baseline and 4 weeks
Fructosamine
analyzed by Randox clinical analyzer
Measured: baseline and 4 weeks
Inflammation markers-Interleukin (IL)-6
Analyzed by Luminex method
Measured: Baseline
Inflammation markers-Interleukin (IL)-10
Analyzed by Luminex method
Measured: Baseline
Inflammation markers-Tumor necrosis factor alpha (TNF-α)
Analyzed by Luminex method
Measured: Baseline
Nuclear Magnetic Resonance (NMR) Lipoprotein Subfraction
Analyzed by Labcorp
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start3 Jun 2026
- Primary completion28 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Nutrition Research Center, Illinois Institute of Technology
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hass Avocado Board
- Responsible party
- Sponsor
- Investigators
- Britt Burton-Freeman, PhD, Principal investigator, Food Sci and Nut Programs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07624500
- Sponsor's protocol ID
- IRB-2026-34
- Acronym
- FAM
- Status last verified
- Jun 2026
- First submitted
- 28 May 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We would make all de-identified IPD collected during the trial (i.e., the study outcomes) publicly available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Avocado on Triglyceride Metabolism in Individuals With Insulin Resistance
- ClinicalTrials.gov ID
- NCT07624500
- Acronym / sponsor ID
- FAM / IRB-2026-34
- Conditions
- Prediabetes, Insulin Resistance, Triglycerides, Lipids Metabolism
- Keywords
- Triglycerides, Insulin resistance, Glucose metabolism, Lipids metabolism
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Clinical Nutrition Research Center, Illinois Institute of TechnologyIndustry (pharma, biotech, devices)
- Collaborators
- Hass Avocado Board
- Study start
- 3 Jun 2026 (actual)
- Primary completion
- 28 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Jun 2026 (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.
In this study, Investigators are interested in looking at the influence of eating avocados regularly, which are rich in healthy fats, fibers, and unique carbohydrates, on triglyceride and glucose metabolism in people with prediabetes and insulin resistance.
Detailed description
The proposed study will be conducted in humans according to Good Clinical Practice (GCP) guidelines. All subjects will review and sign an Informed Consent Form approved by the Illinois Institute of Technology's Institutional Review Boards (IRB) prior to screening. The research is designed as a randomized, 2-arm, parallel, diet-controlled, human clinical trial to investigate the effects of avocado consumption for 4 weeks on triglyceride metabolism in individuals with insulin resistance.
Participants will be asked to do the items described below. Visits will be held at the Clinical Nutrition Research Center (CNRC) on the Illinois Tech Campus, 10 W. 35th St., Suite 3D6-1 Chicago, IL, 60616.
SCREENING VISIT
Eligibility for the study is based on the above list (inclusion and exclusion criteria). Investigators will determine if participants qualify for the study at the Screening Visit by the following measurements:
- General measurements: height, weight, body composition, waist circumference, blood pressure, vitals and body temperature
- Fasting blood glucose (sugar) from a finger prick
- Venous blood collection to assess blood glucose, insulin, and triglycerides
- Pregnancy test, for women under the age of 60
Demographic questionnaire, health and medication questionnaire: participants will be asked to provide personal information, such as their name, date of birth, race, etc. Investigators will also ask them to answer questions about their demographics, health, medical history, and the medications they are taking. Based on the results of the blood draw, questionnaires, measurements, and evaluation of their health, they may meet the criteria and be invited to participate in the study.
PRE-STUDY / PRE-INTERVENTION VISIT (which may be performed on the same or a different day as the screening visit) The Pre-Study visit lasts ~45 minutes to 1 hour and participants will meet with one of our investigators who will provide detailed instructions on procedures of the study and "how to prepare for each of participants study days." They will be trained in all study procedures, including, but not limited to, foods to avoid during the study, medications/supplements to avoid, food diary recording, gastrointestinal diary recording and fasting overnight. Their study dates will be scheduled, and they will be provided with a study booklet, including a study calendar and all instructions covered at the Pre-Study Visit.
Medications/Supplements: If they are taking any medications or supplements that do not interfere with the study or have been OK'd by study staff, they will take those as instructed by their doctor and will record them in their diary. Investigators will train the participants on what foods or supplements are OK and NOT OK during the study at the Pre-Study Visit.
Self-Characteristics and Dietary Surveys: Participants will be asked to complete online surveys that cover usual gastrointestinal symptoms and a 24-hour food recall (https://asa24.nih.gov/).
STUDY DAY VISITS Study Visit 1 / Day 0 and Visit 5 / Day 28 Procedures
Staff collects study materials from the participant
- Diary and provide 24 h recall (https://asa24.nih.gov/) Confirmation participant is ready to go for their study day by interview/discussion with the study staff
- Fasted overnight for 10-12 hours, including finger prick to verify usual fasting glucose
- Had a usual night of sleep (5-6 hours minimum)
- Avoided alcohol and vigorous physical activity 24 hours before the study day
After confirming they are ready for their study day, Investigators will proceed to an exam room to measure:
Anthropometrics: Investigators will measure weight, waist circumference and body composition.
Vital signs: Investigators will check their blood pressure, heart rate, and body temperature using standard clinic devices.
Once Investigators have collected measurements, they will proceed with an IV catheter to collect blood over multiple timepoints.
Blood collection: Participants will see the Licensed Health Care Provider (LHCP) for blood sample collection. Investigators will use an indwelling catheter (IV). This means Investigators will use a needle to put a thin tube in their arm or hand, from which Investigators can get blood samples while keeping them as comfortable as possible. This tube will stay in their arm until all blood drawings are completed during their visit. If there is difficulty with blood flow Investigators will ask the participant if they're comfortable with single stick blood collection, performed by LHCP using a butterfly needle. There will be nine blood draws in total over 5 hours.
Once the fasting blood draw is collected, Investigators will provide the participant with a breakfast in the form of a nutritionally complete liquid meal test (LMT).
Standard Liquid Meal Test (LMT): For this test, they will drink about 2 cups of vanilla flavored Ensure®. Ensure® is a nutritional supplement containing a mixture of sugars, fats, and protein and a variety of vitamins and minerals. The drink contains milk protein (suitable for lactose intolerance) and soy products. Investigators will ask if they are unwilling to consume any ingredients in the Ensure® drink. It may be unsafe for them to complete this test if they have an allergy to any of the components. The total amount participant will drink will be approximately 440 calories, 64g of Carbs, 12g of Fat, and 18g of Protein.
After all blood samples have been collected they will be provided with meals to last until V2 (~ 1 week) and instructed how to fill out the dietary adherence log.
MEAL PICKUP VISITS Study Visit 2 / Day 7, Study Visit 3 / Day 14, Study Visit 4 / Day 21
Participants will not need to come fasted for meal pickup visits. Investigators will collect materials and ensure they are complying with the study protocols, and assess if there are any difficulties Investigators can help with. The following will be done at pickup visits:
Staff collects study materials from the participant 1. Diary and provide 24 h recall (https://asa24.nih.gov/) Staff collects weight and LDN does counseling as needed
- Licensed Dietitian Nutritionist (LDN) will review compliance diary and weight changes and provide nutrition counseling as needed
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Avocado meal plan | Active comparator | Other: Avocado meal plan2 meals and snack per day including one avocado in the meal, covering 80% of daily calories need. |
| Control meal plan | Placebo comparator | Other: Control meal plan2 meals and snacks per day without the inclusion of avocado, covering 80% of daily calories needs. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men or women, 40-70 years of age.
- Fasting triglycerides (TG) >115 mg/dL.
- Insulin resistance as measured by Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) >2.5.
- Able to provide informed consent.
- Able to comply with and perform the procedures requested by the protocol, specifically eat all the meals and snacks provided by the study which will be almost all your food (~ 80% of calories per day).
Key exclusion criteria (16 listed)
- Men and women with known or suspected intolerance, allergies or hypersensitivity to study foods or interventions.
- Fasting blood sugar ≥125 mg/dL. Men and women with blood pressure >160 mmHg (systolic) / 100 mmHg (diastolic) at the screening visit.
- Men and women with history of diabetes cardiovascular events, respiratory, renal, gastrointestinal, hepatic or eye disease or surgery- within a year.
- Men and women who have or had cancer other than non-melanoma skin cancer in the past 5 years.
- Men and women taking over the counter or prescription medications or dietary supplements that may interfere with study procedures or endpoints.
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 |
|---|---|---|
| Avocado meal planAmerican Diet with avocado | Other | Avocado meal plan |
| Control meal planAmerican diet | Other | Control meal plan |
Primary outcome
Changes in serum biomarker: triglycerides
Time frame: baseline and 4 weeks
analyzed by McLendon labs
16 secondary outcomes
Changes in serum biomarker: insulin
Time frame: baseline and 4 weeks
Changes in serum biomarker: glucose
Time frame: baseline and 4 weeks
Changes in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: baseline and 4 weeks
Changes in Muscle Insulin Sensitivity Index (MISI)
Time frame: baseline and 4 weeks
Changes in total cholesterol
Time frame: baseline and 4 weeks
Changes in Low-Density Lipoprotein (LDL) cholesterol
Time frame: baseline and 4 weeks
Changes in High-Density Lipoprotein (HDL) cholesterol
Time frame: baseline and 4 weeks
Changes in non-High-Density Lipoprotein (HDL) cholesterol
Time frame: baseline and 4 weeks
Changes in Connecting Peptide (C-peptide)
Time frame: baseline and 4 weeks
Changes in free fatty acids
Time frame: baseline and 4 weeks
Changes in Glucagon-Like Peptide-1(GLP-1)
Time frame: baseline and 4 weeks
Fructosamine
Time frame: baseline and 4 weeks
Inflammation markers-Interleukin (IL)-6
Time frame: Baseline
Inflammation markers-Interleukin (IL)-10
Time frame: Baseline
Inflammation markers-Tumor necrosis factor alpha (TNF-α)
Time frame: Baseline
Nuclear Magnetic Resonance (NMR) Lipoprotein Subfraction
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: Yes. We would make all de-identified IPD collected during the trial (i.e., the study outcomes) publicly available upon request.
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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.
Britt Burton-Freeman, PhD principal investigator
Food Sci and Nut Programs
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 meal plan in people with Prediabetes and Insulin Resistance, run by Clinical Nutrition Research Center, Illinois Institute of Technology 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 8 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 1 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chelsea Preiss, MS (312-567-5300, cpreiss@illinoistech.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in serum biomarker: triglycerides (time frame: baseline and 4 weeks). 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 1 Jul 2026.