Food and Metabolism Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-70
SponsorClinical Nutrition Research Center, Illinois Institute of Technology
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Avocado meal plan
Other interventionAmerican Diet with avocado
Control meal plan
Other interventionAmerican diet
Treatment groups
82 Participants
are divided into 2 treatment groupsGroup A: Avocado meal planActive comparator 1 intervention
Group B: Control meal planPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Changes in serum biomarker: triglycerides
analyzed by McLendon labs
Time frame
baseline and 4 weeksSecondary outcomes
1
Changes in serum biomarker: insulin
analyzed by McLendon labs
Time frame
baseline and 4 weeks2
Changes in serum biomarker: glucose
analyzed by McLendon labs
Time frame
baseline and 4 weeks3
Changes in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Calculated from fasting glucose and insulin
Time frame
baseline and 4 weeks4
Changes in Muscle Insulin Sensitivity Index (MISI)
calculated using postprandial glucose and insulin concentrations measured by Randox clinical analyzer
Time frame
baseline and 4 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Clinical Nutrition Research Center, Illinois Institute of Technology
Lead sponsor
Hass Avocado Board
Collaborator
Source ClinicalTrials.gov