Assessing the Value of Avocados on Glycemic Control in Type 2 Diabetes

NCT05958368 | Recruiting

• 1 other identifier: PBRC 2023-033
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2; Insulin; Fructosamine; C-Reactive Protein; Glucose; Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

• Fasting Blood Glucose

  the primary outcomes are based on within subject concentration change scores

  Week 5 - Week 0

Secondary Outcomes (3)

• Fasting Insulin

  Week 5 - Week 0

• Fructosamine

  Week 5 - Week 0

• Glycated Albumin

  Week 5 - Week 0

Other Outcomes (3)

• Blood Glucose

  Week 5 - Week 0

• Glucose

  Week 5 - Week 0

• Insulin

  Week 5 - Week 0

Study Arms (2)

Avocado

EXPERIMENTAL

Participants will consume 1 Hass avocado a day.

Other: Avocado

Other Fruit(s)

ACTIVE COMPARATOR

Participants in the other fruit arm will receive other fruits.

Other: Other Fruit(s)

Interventions

Avocado OTHER

The Hass Avocado group will consume 7 avocados a week (1 / day; \~240 kcals/d).

Also known as: Hass Avocado

Avocado

Other Fruit(s) OTHER

The other fruits group will consume fruit(s) matched to the avocado in energy and form (i.e., solid fruit).

Also known as: Raisins, Cantaloupe(s), Figs, Pineapple(s), Grapes, Bananas

Other Fruit(s)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• Prachi Singh: collaborator
• Frank L. Greenway: collaborator
• Robbie A. Beyl: collaborator

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance; Overweight; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• John W Apolzan, PhD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John W Apolzan, PhD

CONTACT

2257632827; John.Apolzan@pbrc.edu

Rob Leonard

CONTACT

2257630948; doctors@pbrc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigators and outcome assessors will be blinded to study treatment.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor-Research

Model Details: This study utilizes a randomized crossover design with each period/treatment being approximately 5 weeks. Participants will be randomized to either Hass Avocado or other fruit(s) consumption groups. The treatments will be isocaloric as will the Hass Avocado vs. the other fruit(s). All subjects will consume a diet provided by the metabolic research kitchen. The diet will be matched on energy (kcal).

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: July 24, 2023
• Study Start: October 10, 2023
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: July 31, 2025

Record last verified: 2025-07

Locations

US (1)