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

Diabetes Mellitus, Type 2 Clinical Trial

— AVOCADO-T2D  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05958368
• Other study ID #: PBRC 2023-033
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2023
• Est. completion date: December 15, 2025

Study information

• Verified date: October 2023
• Source: Pennington Biomedical Research Center
• Contact: John W Apolzan, PhD
• Phone: 2257632827
• Email: John.Apolzan[@]pbrc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 15, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Avocado
The Hass Avocado group will consume 7 avocados a week (1 / day; ~240 kcals/d).
• Other Fruit(s)
The other fruits group will consume fruit(s) matched to the avocado in energy and form (i.e., solid fruit).

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (4)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center	Frank L. Greenway, Prachi Singh, Robbie A. Beyl

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood Glucose	Continuous Glucose Monitoring	Week 5 - Week 0
Other	Glucose	Oral Glucose Tolerance Test (OGTT)	Week 5 - Week 0
Other	Insulin	Oral Glucose Tolerance Test (OGTT)	Week 5 - Week 0
Primary	Fasting Blood Glucose	the primary outcomes are based on within subject concentration change scores	Week 5 - Week 0
Secondary	Fasting Insulin	within subject concentration change scores	Week 5 - Week 0
Secondary	Fructosamine	within subject concentration change scores	Week 5 - Week 0
Secondary	Glycated Albumin	within subject concentration change scores	Week 5 - Week 0