Effects of Replacing Energy From Solid Fats and Added Sugars (SoFAS) With Avocado

NCT04990817 | Completed

• 1 other identifier: MB-1914
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief 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 pressure in men and women with elevated triglycerides (TG).

Conditions

Elevated Triglycerides; Hypertriglyceridemia

Outcome Measures

Primary Outcomes (1)

• Non-HDL-C

  Percent change from baseline to the end of each treatment condition in non-HDL-C

  Up to 21 days for each treatment period

Secondary Outcomes (10)

• Total cholesterol (Total-C)

  Up 21 days for each treatment period

• High-density lipoprotein cholesterol (HDL-C)

  Up to 21 days for each treatment period

• Low-density lipoprotein cholesterol (HDL-C)

  Up to 21 days for each treatment period

• Triglyceride (TG)

  Up to 21 days for each treatment period

• Total-C/HDL-C Ration

  Up to 21 days for each treatment period

Study Arms (2)

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).

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.

Other: Average American Diet

Interventions

Average American Diet With SoFAS Replaced With Avocado OTHER

Replacing energy from solid fats and added sugars (SoFAS) with Avocado as part of an average American diet

Average American Diet With SoFAS Replaced With Avocado

Average American Diet OTHER

Average American diet based on macronutrient analyses from the most recent Nutrition and Health Examination Survey.

Average American Diet

Eligibility Criteria

• Age: 21 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Midwest Center for Metabolic and Cardiovascular Research: lead
• Hass Avocado Board: collaborator

Study Sites (2)

Great Lakes Clinical Trials

Chicago, Illinois, 60640, United States

Location

I-CTSI Clinical Research Center

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

• 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. 2025 Dec 13:101137. doi: 10.1016/j.ajcnut.2025.101137. Online ahead of print.

  PMID: 41397527 DERIVED

MeSH Terms

Conditions

Hypertriglyceridemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: August 5, 2021
• Study Start: June 18, 2021
• Primary Completion: April 17, 2024
• Study Completion: April 17, 2024
• Last Updated: May 21, 2024

Record last verified: 2024-05

Locations

US (2)