Opening soonNot applicableInterventional
What this study is about
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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 70 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity, Type 2 Diabetes
Full registry criteria
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
