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NCT Number: NCT05958368

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location status: Recruiting

Location contact

John W Apolzan, PhD

CONTACT

[email protected]

225-763-2827

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Avocado

Other

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

Other names: Hass 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).

Other names: Raisins, Cantaloupe(s), Figs, Pineapple(s), Grapes, Bananas

Primary outcomes

  1. Fasting Blood Glucose

    Time frame: Week 5 - Week 0

    the primary outcomes are based on within subject concentration change scores

Secondary outcomes

  1. Fasting Insulin

    Time frame: Week 5 - Week 0

    within subject concentration change scores

  2. Fructosamine

    Time frame: Week 5 - Week 0

    within subject concentration change scores

  3. Glycated Albumin

    Time frame: Week 5 - Week 0

    within subject concentration change scores

Other outcomes

  1. Blood Glucose

    Time frame: Week 5 - Week 0

    Continuous Glucose Monitoring

  2. Glucose

    Time frame: Week 5 - Week 0

    Oral Glucose Tolerance Test (OGTT)

  3. Insulin

    Time frame: Week 5 - Week 0

    Oral Glucose Tolerance Test (OGTT)

Study contacts

Contact information is provided by the study sponsor or research team.

John W Apolzan, PhD

CONTACT

[email protected]

2257632827

Rob Leonard

CONTACT

[email protected]

2257630948

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Collaborators

  • Frank L. Greenway
  • Prachi Singh
  • Robbie A. Beyl

Registry information

Official study title

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

Acronym: AVOCADO-T2D

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 24, 2023
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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