Ability of Almonds to Improve Nutrition During GLP-1 Treatment

The Ability of Almonds to Increase Vitamin E (Alpha-tocopherol) and Diet Quality During GLP-1 Treatment: A Randomized Controlled Pilot Trial

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.

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