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

NCT ID: NCT05958368

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-10
• Study Completion Date: 2026-12-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Avocado

Participants will consume 1 Hass avocado a day.

Group Type: EXPERIMENTAL

Avocado

Intervention Type: OTHER

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

Other Fruit(s)

Participants in the other fruit arm will receive other fruits.

Group Type: ACTIVE_COMPARATOR

Other Fruit(s)

Intervention Type: OTHER

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

Interventions

Avocado

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

Intervention Type: OTHER

Other Fruit(s)

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

Intervention Type: OTHER

Other Intervention Names

Hass Avocado; Raisins, Cantaloupe(s), Figs, Pineapple(s), Grapes, Bananas

Eligibility Criteria

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

• 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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Prachi Singh

UNKNOWN

Sponsor Role: collaborator

Frank L. Greenway

UNKNOWN

Sponsor Role: collaborator

Robbie A. Beyl

UNKNOWN

Sponsor Role: collaborator

Pennington Biomedical Research Center

OTHER

Sponsor Role: lead

Responsible Party

John Apolzan

Associate Professor-Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John W Apolzan, PhD

Role: PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research Center

Locations

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

John W Apolzan, PhD

Role: CONTACT

John.Apolzan@pbrc.edu

2257632827

Rob Leonard

Role: CONTACT

doctors@pbrc.edu

2257630948

Facility Contacts

John W Apolzan, PhD

Role: primary

john.apolzan@pbrc.edu

225-763-2827

Other Identifiers

PBRC 2023-033

Identifier Type: -

Identifier Source: org_study_id