Assessing the Value of Avocados on Glycemic Control in Type 2 Diabetes (AVOCADO-T2D)

The Effects of Hass Avocados on Glycemic Control in Persons With Type 2 Diabetes: A Randomized Controlled Crossover Trial

The objective of this study is to assess the effects of Hass Avocados on glycemic control. The investigators hypothesize that Hass Avocado consumption will reduce fasting blood sugar compared to an isocaloric amount of other fruit during controlled feeding.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2; Overweight and Obesity; Insulin; Glucose; C-Reactive Protein; Fructosamine
• Intervention / Treatment: Other: Avocado; Other: Other Fruit(s)

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: John W Apolzan, PhD; Phone Number: 2257632827; Email: john.apolzan@pbrc.edu
• Study Contact Backup: Name: Rob Leonard; Phone Number: 2257630948; Email: doctors@pbrc.edu

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Recruiting
      • Pennington Biomedical Research Center
      • Contact: John W Apolzan, PhD; Phone Number: 225-763-2827; Email: john.apolzan@pbrc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Participant reported diagnosis of Type 2 diabetes
• HbA1c between 5.7%-11% (inclusive) and / or fasting blood glucose of ≥ 100 mg/dL
• BMI 27-50 kg/m2 (inclusive)
• Age range - 18 - 65 years (inclusive)
• On stable regimen of all medications (including diabetes) for at least 3 months (brief regimens of medications such as antibiotics, steroids, etc. are permitted)
• Willing to follow all requirements of study protocol including blood draws
• Under the care of a physician who will be responsible for managing the subject's diabetes
• Willing to give release to provide their treating MD with information about the trial

Exclusion Criteria:

• Not willing or unable to consume study foods including avocados
• Participation in a weight control program within the past 3 months or weight loss of ≥ 5 kg in the previous 3 months
• Taking prescription or OTC weight loss medications within last 4 weeks
• History of a surgical procedure for weight loss in last 5 years (e.g. gastroplasty, gastric by-pass, gastrectomy or partial gastrectomy, adjustable banding, gastric sleeve)
• History of major surgery within three months of enrollment
• Type 1 diabetes, insulin dependent type 2 diabetes, thiazolidinediones (including rosiglitazone and pioglitazone)
• Renal insufficiency consisting of potassium over 5.5 (mmol/L) on a non-hemolyzed specimen, or a creatinine over 2.5 mg/dL
• Bilirubin over 3 (mg/dL) or an albumin less than 3 (g/dL)
• ALT > 3 (IU/L) times the upper limit of normal (normal range is 7-56)
• Evidence of more than 1 severe hypoglycemic event (episode requiring emergency medical services) in the past 12 months, unless the participant's treating physician provides written clearance for participation.
• Those on higher doses of diuretics (furosemide 40mg or higher or comparable)
• Unstable heart disease (an ongoing workup or treatment for a cardiac symptom such as unstable angina, coronary ischemia)
• Presence of implanted cardiac defibrillator
• Blood pressure ≥180/100 mm Hg. If a potential participant has a BP above the inclusion criteria it is acceptable to re-test this potential participant within one week of the original test.
• Thyroid disease for which the participant is untreated or has had treatment changed within the last 6 months. History of thyroid disease or current thyroid disease treated with a stable medication regimen for at least 6 months is acceptable
• Uncontrolled gastrointestinal disorders including chronic malabsorptive conditions, peptic ulcer disease, Crohn's disease, chronic diarrhea, or active gallbladder disease
• Current cancer or cancer treatment, or a history of cancer or cancer treatment within the last 3 years. Persons with successfully resected non-melanoma carcinoma of the skin may be enrolled.
• Dementia, psychiatric illness, or substance abuse that may interfere with adherence (e.g., illness that is currently unstable or resistant to first-line therapy; substance abuse in the past year)
• Women who are pregnant, lactating, trying to become pregnant or unwilling to use an effective means of birth control
• Currently consuming >14 alcoholic drinks (1 drink = 12 fl oz beer, 4 fl oz wine or 1.5 fl oz liquor) per week and unwilling to stop intake during study participation
• Participation in another clinical trial within 30 days prior to enrollment
• Any other condition or factor which in the opinion of the study physician or investigator makes it inadvisable for the candidate to participate in the trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Avocado; Participants will consume 1 Hass avocado a day.	Other: Avocado; The Hass Avocado group will consume 7 avocados a week (1 / day; ~240 kcals/d).; Other Names: Hass Avocado
Active Comparator: Other Fruit(s); Participants in the other fruit arm will receive other fruits.	Other: Other Fruit(s); The other fruits group will consume fruit(s) matched to the avocado in energy and form (i.e., solid fruit).; Other Names: Raisins, Cantaloupe(s), Figs, Pineapple(s), Grapes, Bananas

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting Blood Glucose	the primary outcomes are based on within subject concentration change scores	Week 5 - Week 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting Insulin	within subject concentration change scores	Week 5 - Week 0
Fructosamine	within subject concentration change scores	Week 5 - Week 0
Glycated Albumin	within subject concentration change scores	Week 5 - Week 0

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Glucose	Continuous Glucose Monitoring	Week 5 - Week 0
Glucose	Oral Glucose Tolerance Test (OGTT)	Week 5 - Week 0
Insulin	Oral Glucose Tolerance Test (OGTT)	Week 5 - Week 0

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center
• Collaborators: Frank L. Greenway; Robbie A. Beyl; Prachi Singh
• Investigators: Principal Investigator: John W Apolzan, PhD, Pennington Biomedical Research Center

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2023
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): December 15, 2025

Study Registration Dates

• First Submitted: July 14, 2023
• First Submitted That Met QC Criteria: July 14, 2023
• First Posted (Actual): July 24, 2023

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Diabetes Mellitus; Diabetes Mellitus, Type 2; Overweight
• Other Study ID Numbers: PBRC 2023-033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data may be requested. The PI and sponsor will be notified. The proposed research question must be included. All IPD that underlie results in a publication after a DTA with the institution.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No