Recruiting NCT05958368
Assessing the Value of Avocados on Glycemic Control in Type 2 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Avocado, Other Fruit(s).
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, Type 2, Insulin, Fructosamine, C-Reactive Protein. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effects of Hass Avocados on Glycemic Control in Persons With Type 2 Diabetes: A Randomized Controlled Crossover Trial
Overview
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.
Interventions
- Other Avocado
The Hass Avocado group will consume 7 avocados a week (1 / day; \~240 kcals/d). - Other Other Fruit(s)
The other fruits group will consume fruit(s) matched to the avocado in energy and form (i.e., solid fruit).
Primary outcome measures
- Fasting Blood Glucose [Time frame: Week 5 - Week 0]
Secondary outcome measures (3)
- Fasting Insulin [Time frame: Week 5 - Week 0]
- Fructosamine [Time frame: Week 5 - Week 0]
- Glycated Albumin [Time frame: Week 5 - Week 0]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Pennington Biomedical Research Center — Baton Rouge
Identifiers
NCT: NCT05958368 · PBRC 2023-033