Elevated TriglyceridesNCT04990817
Effects of Replacing Energy From Solid Fats and Added Sugars (SoFAS) With Avocado
A study testing Average American Diet With SoFAS Replaced With Avocado and Average American Diet in people with Elevated Triglycerides and Hypertriglyceridemia, run by Midwest Center for Metabolic and Cardiovascular Research at 2 sites in United States.
Trial summary
The objective of this study is to assess the effects of replacing energy from SoFAS with energy from avocado on non-high-density lipoprotein cholesterol (non-HDL-C) and other aspects of the cardiometabolic health profile including fasting lipoprotein lipid and particle concentrations, insulin sensitivity and blood… Read more about this study
- Who is it for?
- Ages 21 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Elevated Triglycerides, Hypertriglyceridemia
- What is being tested?
- Average American Diet With SoFAS Replaced With Avocado and Average American Diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Jun 2021to 17 Apr 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 21 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female 21 to 74 y of age, inclusive.
- Subject has a fasting fingerstick TG level of ≥135 mg/dL and <500 mg/dL at screening.
- Subject has a BMI of 25.00 to 39.99 kg/m2, inclusive.
- Subject has a vein access score of 7-10.
- Subject is normally active and judged by the Investigator to be in general good health on the basis of medical history and screening measurements.
- Subject is willing to comply with study food and background diet consumption during each treatment condition.
Show all 13Show fewer
- Subject is willing follow his/her regular physical activity pattern throughout the study period.
- Subject is willing to refrain from consumption of all forms of recreational and/or medicinal marijuana (if legal) and alcoholic beverages for 24 h prior to each clinic visit requiring a blood draw.
- Subject is willing to refrain from vigorous physical activity for 24 h prior to each clinic visit requiring a blood draw.
- Subject is willing to abstain from caffeine use 1 h prior to and during each clinic visit
- Subject is a non-smoker (at least 6 months), does not vape, and does not use other nicotine products and will abstain from use during the study period.
- Subject who uses cannabidiol (CBD) and/or tetrahydrocannabinol (THC) has no plans to change habits during the study period.
- Subject understands the study procedures and signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator and is willing to complete study procedures.
Who cannot join
- Subject has a laboratory test result of clinical significance based on the judgment of the Principal Investigator or qualified designee.
- Subject has positive urine drug screen for illicit drugs.
- Subject has fasting blood glucose ≥126 mg/dL at screening or known type 1 or type 2 diabetes mellitus.
- Subject has atherosclerotic cardiovascular disease including any of the following: clinical signs of atherosclerosis including peripheral arterial disease, abdominal aortic aneurysm, carotid artery disease (symptomatic [e.g., myocardial infarction, angina, transient ischemic attack or stroke of carotid origin] or >50% stenosis on angiography or ultrasound) or other forms of clinical atherosclerotic disease (e.g., renal artery disease).
- Subject has history or presence of a clinically significant gastrointestinal, endocrine, renal, hepatic, hematologic, immunologic, dermatologic, pulmonary, pancreatic, neurologic, psychiatric, inflammatory or biliary disorder that, in the opinion of the Investigator, could interfere with the interpretation of the study results.
- Subject has a history of cancer in the prior 2 years, with the exception of non- melanoma skin cancer or carcinoma in situ of the cervix.
Show all 25Show fewer
- Subject has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg) at screening.
- Subject has unstable use (defined as initiation or change in dose) of anti-hypertensive medication or thyroid hormone replacement within 4 weeks of screening.
- Subject has used beta-adrenergic blockers and/or high-dose (>25 mg/d) thiazide diuretics within 4 weeks of screening.
- Subject has unstable use (defined as initiation or change in dose, agent, or regimen) of statins within 4 weeks of screening.
- Subject has used lipid-altering drugs other than statins including, but not limited to, bile acid sequestrants, cholesterol absorption inhibitors or fibrates within 4 weeks of screening.
- Subject has used diabetes medications including alpha-glucosidase inhibitors, biguanides and biguanide combinations, thiazolidinediones, dipeptidyl peptidase-4 inhibitors, meglitinides and sulfonylureas and combination sulfonylureas within 4 weeks of screening.
- Subject has used systemic corticosteroids within 4 weeks of screening.
- Subject has used weight-loss drugs (including over-the-counter medications and/or supplements) or programs within 4 weeks prior to screening.
- Subject has used lipid-altering foods, herbs or dietary supplements, including omega-3 fatty acid supplements with ≥900 mg/d EPA (eicosapentaenoic acid) or DHA (docosahexaenoic acid), niacin or its analogs at doses >200 mg/d, sterol/stanol products, dietary fiber supplements or red rice yeast supplements within 2 weeks of screening.
- Subject has used dietary supplements that may affect carbohydrate metabolism, including chromium picolinate, ginseng, cinnamon (as a supplement) and starch blockers within 2 weeks of screening.
- Subject has had a weight change of ±4.5 kg (10 lbs) in the previous 3 months.
- Subject has an active infection and/or is on antibiotic therapy. Subject can be rescheduled for screening 7 days after completion of antibiotic therapy.
- Subject has extreme dietary habits (e.g., vegan or very low carbohydrate diet).
- Subject has a history of a diagnosed eating disorder (e.g., anorexia or bulimia nervosa).
- Subject is a female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period.
- Subject has a known allergy, sensitivity or intolerance to any foods.
- Subject has been exposed to any non-registered drug product within 30 days of screening.
- Subject has a current or recent history (past 12 months of screening) or strong potential for illicit drug or alcohol abuse. Alcohol abuse will be defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1.5 oz hard liquor).
- Subject has a condition the Investigator believes would interfere with his or her ability to provide informed consent or comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Great Lakes Clinical Trials
Chicago, Illinois, 60640
I-CTSI Clinical Research Center
Indianapolis, Indiana, 46202
About this study
Official title: A Randomized, Controlled-feeding, Double-blind, Crossover Study to Examine the Metabolic Effects of Replacing Energy From Solid Fats and Added Sugars (SoFAS) With Avocado in Men and Women With Elevated Triglycerides
The objective of this study is to assess the effects of replacing energy from SoFAS with energy from avocado on non-high-density lipoprotein cholesterol (non-HDL-C) and other aspects of the cardiometabolic health profile including fasting lipoprotein lipid and particle concentrations, insulin sensitivity and blood pressure in men and women with elevated triglycerides (TG).
- Conditions
- Elevated Triglycerides, Hypertriglyceridemia
- Being tested
- Average American Diet With SoFAS Replaced With Avocado, Average American Diet
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Average American Diet With SoFAS Replaced With AvocadoOther
Replacing energy from solid fats and added sugars (SoFAS) with Avocado as part of an average American diet
Average American DietOther
Average American diet based on macronutrient analyses from the most recent Nutrition and Health Examination Survey.
| Study group | Role | What they receive |
|---|---|---|
| Average American Diet With SoFAS Replaced With Avocado | Experimental | Average American diet with foods that provide the equivalent of 1 medium to large avocado per day. It is anticipated that energy from avocado would replace 12-15% of daily energy, roughly half from solid fats and half from added sugars (SoFAS). Receives: Other: Average American Diet With SoFAS Replaced With Avocado |
| Average American Diet | Placebo comparator | Average American diet based on macronutrient analyses from the most recent Nutrition and Health Examination Survey. Receives: Other: Average American Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-HDL-C
Percent change from baseline to the end of each treatment condition in non-HDL-C
Measured: Up to 21 days for each treatment period
Secondary outcomes (10)
Total cholesterol (Total-C)
Change or percent change from baseline to the end of each treatment condition
Measured: Up 21 days for each treatment period
High-density lipoprotein cholesterol (HDL-C)
Change or percent change from baseline to the end of each treatment condition
Measured: Up to 21 days for each treatment period
Low-density lipoprotein cholesterol (HDL-C)
Change or percent change from baseline to the end of each treatment condition
Measured: Up to 21 days for each treatment period
Triglyceride (TG)
Change or percent change from baseline to the end of each treatment condition
Measured: Up to 21 days for each treatment period
Total-C/HDL-C Ration
Change or percent change from baseline to the end of each treatment condition
Measured: Up to 21 days for each treatment period
Lipoprotein particle and subclass concentrations
Change or percent change from baseline to the end of each treatment condition
Measured: Up to 21 days for each treatment period
Matsuda insulin sensitivity index
Change or percent change from baseline to the end of each treatment condition
Measured: Up to 21 days for each treatment period
Disposition index from the liquid meal tolerance test [LMTT] (a measure of pancreatic beta-cell function)
Change or percent change from baseline to the end of each treatment condition
Measured: Measured at baseline and end of each treatment period
Homeostasis model assessments of insulin sensitivity (HOMA2-%S), insulin resistance (HOMA-IR, linear model) and beta-cell function (HOMA2-%B)
Change or percent change from baseline to the end of each treatment condition
Measured: Up to 21 days for each treatment period
Seated, resting systolic and diastolic blood pressures and heart rate
Change or percent change from baseline to the end of each treatment condition
Measured: Up to 21 days for each treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start18 Jun 2021
- Primary completion17 Apr 2024
- Study completion17 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Elevated TriglyceridesStudies 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Midwest Center for Metabolic and Cardiovascular Research
- Sponsor type
- University, hospital or other
- Collaborators
- Hass Avocado Board
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04990817
- Sponsor's protocol ID
- MB-1914
- Status last verified
- May 2024
- First submitted
- 26 Jul 2021
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gletsu-Miller N, Wilcox ML, Spence LA, Wright AJ, Guarneiri LL, Nadeem MM, Hutter MJ, Sprague KL, Brown AW, Friedman AN, Kirkpatrick CF, Maki KC. Effects of replacing solid fats and added sugars with avocado in adults with elevated cardiometabolic risk: a randomized, double-blind, controlled feeding, crossover trial. Am J Clin Nutr. 2026 Feb;123(2):101137. doi: 10.1016/j.ajcnut.2025.101137. Epub 2025 Dec 13.
PubMed 41397527
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled-feeding, Double-blind, Crossover Study to Examine the Metabolic Effects of Replacing Energy From Solid Fats and Added Sugars (SoFAS) With Avocado in Men and Women With Elevated Triglycerides
- ClinicalTrials.gov ID
- NCT04990817
- Acronym / sponsor ID
- MB-1914
- Conditions
- Elevated Triglycerides, Hypertriglyceridemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Midwest Center for Metabolic and Cardiovascular ResearchUniversity, hospital or other
- Collaborators
- Hass Avocado Board
- Study start
- 18 Jun 2021 (actual)
- Primary completion
- 17 Apr 2024 (actual)
- Study completion
- 17 Apr 2024 (actual)
- First posted
- 5 Aug 2021 (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 objective of this study is to assess the effects of replacing energy from SoFAS with energy from avocado on non-high-density lipoprotein cholesterol (non-HDL-C) and other aspects of the cardiometabolic health profile including fasting lipoprotein lipid and particle concentrations, insulin sensitivity and blood pressure in men and women with elevated triglycerides (TG).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Average American Diet With SoFAS Replaced With Avocado | Experimental | Other: Average American Diet With SoFAS Replaced With AvocadoAverage American diet with foods that provide the equivalent of 1 medium to large avocado per day. It is anticipated that energy from avocado would replace 12-15% of daily energy, roughly half from solid fats and half from added sugars (SoFAS). |
| Average American Diet | Placebo comparator | Other: Average American DietAverage American diet based on macronutrient analyses from the most recent Nutrition and Health Examination Survey. |
Who may qualify
- Ages
- 21 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or female 21 to 74 y of age, inclusive.
- Subject has a fasting fingerstick TG level of ≥135 mg/dL and <500 mg/dL at screening.
- Subject has a BMI of 25.00 to 39.99 kg/m2, inclusive.
- Subject has a vein access score of 7-10.
- Subject is normally active and judged by the Investigator to be in general good health on the basis of medical history and screening measurements.
Key exclusion criteria (25 listed)
- Subject has a laboratory test result of clinical significance based on the judgment of the Principal Investigator or qualified designee.
- Subject has positive urine drug screen for illicit drugs.
- Subject has fasting blood glucose ≥126 mg/dL at screening or known type 1 or type 2 diabetes mellitus.
- Subject has atherosclerotic cardiovascular disease including any of the following: clinical signs of atherosclerosis including peripheral arterial disease, abdominal aortic aneurysm, carotid artery disease (symptomatic [e.g., myocardial infarction, angina, transient ischemic attack or stroke of carotid origin] or >50% stenosis on angiography or ultrasound) or other forms of clinical atherosclerotic disease (e.g., renal artery disease).
- Subject has history or presence of a clinically significant gastrointestinal, endocrine, renal, hepatic, hematologic, immunologic, dermatologic, pulmonary, pancreatic, neurologic, psychiatric, inflammatory or biliary disorder that, in the opinion of the Investigator, could interfere with the interpretation of the study results.
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 |
|---|---|---|
| Average American Diet With SoFAS Replaced With AvocadoReplacing energy from solid fats and added sugars (SoFAS) with Avocado as part of an average American diet | Other | Average American Diet With SoFAS Replaced With Avocado |
| Average American DietAverage American diet based on macronutrient analyses from the most recent Nutrition and Health Examination Survey. | Other | Average American Diet |
Primary outcome
Non-HDL-C
Time frame: Up to 21 days for each treatment period
Percent change from baseline to the end of each treatment condition in non-HDL-C
10 secondary outcomes
Total cholesterol (Total-C)
Time frame: Up 21 days for each treatment period
High-density lipoprotein cholesterol (HDL-C)
Time frame: Up to 21 days for each treatment period
Low-density lipoprotein cholesterol (HDL-C)
Time frame: Up to 21 days for each treatment period
Triglyceride (TG)
Time frame: Up to 21 days for each treatment period
Total-C/HDL-C Ration
Time frame: Up to 21 days for each treatment period
Lipoprotein particle and subclass concentrations
Time frame: Up to 21 days for each treatment period
Matsuda insulin sensitivity index
Time frame: Up to 21 days for each treatment period
Disposition index from the liquid meal tolerance test [LMTT] (a measure of pancreatic beta-cell function)
Time frame: Measured at baseline and end of each treatment period
Homeostasis model assessments of insulin sensitivity (HOMA2-%S), insulin resistance (HOMA-IR, linear model) and beta-cell function (HOMA2-%B)
Time frame: Up to 21 days for each treatment period
Seated, resting systolic and diastolic blood pressures and heart rate
Time frame: Up to 21 days for each treatment period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Derived from this study: PubMed 41397527Gletsu-Miller N, Wilcox ML, Spence LA, Wright AJ, Guarneiri LL, Nadeem MM, Hutter MJ, Sprague KL, Brown AW, Friedman AN, Kirkpatrick CF, Maki KC. Effects of replacing solid fats and added sugars with avocado in adults with elevated cardiometabolic risk: a randomized, double-blind, controlled feeding, crossover trial. Am J Clin Nutr. 2026 Feb;123(2):101137. doi: 10.1016/j.ajcnut.2025.101137. Epub 2025 Dec 13.
Related trials for Elevated Triglycerides
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Not yet recruitingPhase 4
Effectiveness and Tolerability of a Treat-to-Target Versus Fixed-Dose Statin Strategy in Patients With Atherosclerotic Cardiovascular Disease
Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia, Stroke (CVA) or TIA
RecruitingPhase 2
A Study of Solbinsiran (LY3561774) in Participants With Severe Hypertriglyceridemia
Severe Hypertriglyceridemia
Recruiting
Pemafibrate for Symptomatic ICAS RCT
Intracranial Atherosclerotic Disease (ICAD), Hypertriglyceridaemia
RecruitingPhase 2
A Study to Assess the Safety, Tolerability and Efficacy of ION775
Hypertriglyceridemia, Severe Hypertriglyceridemia
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Average American Diet With SoFAS Replaced With Avocado and Average American Diet in people with Elevated Triglycerides and Hypertriglyceridemia, run by Midwest Center for Metabolic and Cardiovascular Research at 2 sites 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 13 inclusion and 25 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: finished, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-HDL-C (time frame: Up to 21 days for each treatment period). 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 NCT04990817, which also lists 1 linked publication.
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 21 May 2024.