Diabetes Mellitus, Type 2AVOCADO-T2DNCT05958368
Assessing the Value of Avocados on Glycemic Control in Type 2 Diabetes
A study testing Avocado and Other Fruit(s) in people with Diabetes Mellitus, Type 2 and Insulin, run by Pennington Biomedical Research Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Insulin, Fructosamine
- What is being tested?
- Avocado and Other Fruit(s)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2023to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: The Effects of Hass Avocados on Glycemic Control in Persons With Type 2 Diabetes: A Randomized Controlled Crossover Trial
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
- Being tested
- Avocado, Other Fruit(s)
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvocadoOther
Also called Hass Avocado
The Hass Avocado group will consume 7 avocados a week (1 / day; ~240 kcals/d).
Other Fruit(s)Other
Also called Raisins, Cantaloupe(s), Figs, Pineapple(s), Grapes, Bananas
The other fruits group will consume fruit(s) matched to the avocado in energy and form (i.e., solid fruit).
| Study group | Role | What they receive |
|---|---|---|
| Avocado | Experimental | Participants will consume 1 Hass avocado a day. Receives: Other: Avocado |
| Other Fruit(s) | Active comparator | Participants in the other fruit arm will receive other fruits. Receives: Other: Other Fruit(s) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting Blood Glucose
the primary outcomes are based on within subject concentration change scores
Measured: Week 5 - Week 0
Secondary outcomes (3)
Fasting Insulin
within subject concentration change scores
Measured: Week 5 - Week 0
Fructosamine
within subject concentration change scores
Measured: Week 5 - Week 0
Glycated Albumin
within subject concentration change scores
Measured: Week 5 - Week 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start10 Oct 2023
- Primary completion30 Nov 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Prachi Singh, Frank L. Greenway, Robbie A. Beyl
- Responsible party
- Principal investigator, John Apolzan, Pennington Biomedical Research Center
- Investigators
- John W Apolzan, PhD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05958368
- Sponsor's protocol ID
- PBRC 2023-033
- Acronym
- AVOCADO-T2D
- Status last verified
- Sep 2026
- First submitted
- 14 Jul 2023
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data may be requested. The PI and sponsor will be notified. The proposed research question must be included. All IPD that underlie results in a publication after a DTA with the institution.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Hass Avocados on Glycemic Control in Persons With Type 2 Diabetes: A Randomized Controlled Crossover Trial
- ClinicalTrials.gov ID
- NCT05958368
- Acronym / sponsor ID
- AVOCADO-T2D / PBRC 2023-033
- Conditions
- Diabetes Mellitus, Type 2, Insulin, Fructosamine, C-Reactive Protein, Glucose, Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- Prachi Singh, Frank L. Greenway, Robbie A. Beyl
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 24 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Avocado | Experimental | Other: AvocadoParticipants will consume 1 Hass avocado a day. |
| Other Fruit(s) | Active comparator | Other: Other Fruit(s)Participants in the other fruit arm will receive other fruits. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AvocadoAlso: Hass AvocadoThe Hass Avocado group will consume 7 avocados a week (1 / day; ~240 kcals/d). | Other | Avocado |
| Other Fruit(s)Also: Raisins, Cantaloupe(s), Figs, Pineapple(s), Grapes, BananasThe other fruits group will consume fruit(s) matched to the avocado in energy and form (i.e., solid fruit). | Other | Other Fruit(s) |
Primary outcome
Fasting Blood Glucose
Time frame: Week 5 - Week 0
the primary outcomes are based on within subject concentration change scores
3 secondary outcomes
Fasting Insulin
Time frame: Week 5 - Week 0
Fructosamine
Time frame: Week 5 - Week 0
Glycated Albumin
Time frame: Week 5 - Week 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: Undecided. Data may be requested. The PI and sponsor will be notified. The proposed research question must be included. All IPD that underlie results in a publication after a DTA with the institution.
Related trials for Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John W Apolzan, PhD principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Avocado and Other Fruit(s) in people with Diabetes Mellitus, Type 2 and Insulin, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting Blood Glucose (time frame: Week 5 - Week 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.