Effects of Avocados on Blood Sugar Control in Type 2 Diabetes

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

This study tests whether eating Hass avocados can help people with Type 2 diabetes better control their blood sugar compared to other fruits.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Pennington Biomedical Research Center (other)
• Locations: 1 site (Baton Rouge, Louisiana)
• Trial ID: NCT05958368 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the impact of consuming Hass Avocados on glycemic control in individuals with Type 2 diabetes. Participants will consume avocados and an isocaloric amount of other fruits in a controlled feeding setting to compare their effects on fasting blood sugar levels. The study will include adults aged 18 to 65 with a diagnosis of Type 2 diabetes and specific blood glucose levels. Participants will be monitored under the care of their physician throughout the study.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with Type 2 diabetes, stable on their medications, and willing to consume avocados.

Not a fit: Patients who are not willing to consume avocados or have recently lost significant weight may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into dietary interventions that improve blood sugar control for patients with Type 2 diabetes.

How similar studies have performed: While dietary interventions for diabetes have been explored, the specific focus on Hass Avocados in this context is relatively novel.

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

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

Where this trial is running

Baton Rouge, Louisiana

• Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States (RECRUITING)

Study contacts

• Principal investigator: John W Apolzan, PhD — Pennington Biomedical Research Center
• Study coordinator: John W Apolzan, PhD

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