What this trial means for you
This study is opening soon at 1 US site. It's studying see the official record for obesity, type 2 diabetes.
What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study, ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.
The study, in the sponsor's words
This 8-week randomized controlled pilot trial is to test the hypothesis that, compared to a Usual Diet control group, almond intake will increase vitamin E (alpha-tocopherol) levels in the blood and improve diet quality (Healthy Eating Index) among people prescribed a glucagon-like peptide-1. Two groups of individuals will either: 1) consume a minimum of 56 grams of almonds each day, or 2) not consume almonds and follow their usual diet.
Can you join? The exact criteria
Below is the verbatim eligibility text from the registry. Bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.
Full eligibility criteria (for you and your doctor)
Inclusion Criteria: * Adults aged 18-70 years * BMI ≥ 27 kg/m2 - 47.5 kg/m2 and diagnosed with type 2 diabetes by their personal physician (e.g., primary care physician, endocrinologist), or BMI ≥ 30 kg/m2 and have obesity and stable access (i.e., at least a two-month supply) to the medication * Prescribed branded injectable semaglutide or injectable tirzepatide (medication will not be provided as part of the study) * HbA1c will be measured at Pennington Biomedical at baseline (and follow-up), though the baseline HbA1c levels from Pennington Biomedical will not be used for eligibility criteria * Use of other medications (diabetes medications or otherwise) are permitted at the discretion of the Medical Investigator * Enroll and complete baseline assessments prior to starting pharmacotherapy * Able and willing to adhere to all study-related procedures Exclusion Criteria: * Pregnancy or breastfeeding * Taking or planning to take during the trial a medication, vitamin, or mineral supplement that affects vitamin E levels * Previous use of a glucagon-like peptide-1 medication in the last 3 months * Contraindications to glucagon-like peptide-1 medication use or previous adverse reaction/allergy to a glucagon-like peptide-1 receptor agonist medication * Medical, psychological, cognitive, or other conditions that limit the ability to complete study procedure * History of bariatric surgery * Allergic to almonds * Active malignancy, excluding some skin cancers, or undergoing chemotherapy/radiotherapy
Study sites by state
Louisiana
- Pennington Biomedical Research Center, Baton Rouge
View the official record on ClinicalTrials.gov →
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