NCT05958368 Assessing the Value of Avocados on Glycemic Control in Type 2 Diabetes
| NCT ID | NCT05958368 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pennington Biomedical Research Center |
| Condition | Diabetes Mellitus, Type 2 |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2023-10-10 |
| Primary Completion | 2026-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 48 participants in total. It began in 2023-10-10 with a primary completion date of 2026-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
John W Apolzan, PhD
PRINCIPAL INVESTIGATOR
Pennington Biomedical Research Center
Frequently Asked Questions
Who can join the NCT05958368 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Diabetes Mellitus, Type 2. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05958368 currently recruiting?
Yes, NCT05958368 is actively recruiting participants. Contact the research team at John.Apolzan@pbrc.edu for enrollment information.
Where is the NCT05958368 trial being conducted?
This trial is being conducted at Baton Rouge, United States.
Who is sponsoring the NCT05958368 clinical trial?
NCT05958368 is sponsored by Pennington Biomedical Research Center. The principal investigator is John W Apolzan, PhD at Pennington Biomedical Research Center. The trial plans to enroll 48 participants.
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