Ability of Almonds to Improve Nutrition During GLP-1 Treatment

ConditionsObesity Type 2 Diabetes

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-70

SponsorPennington Biomedical Research Center

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Almond Diet
Other intervention
Participants on a glucagon-like peptide-1 medication will be provided with up to 84 grams per day of almonds and coached to consume at least 56 grams per day.

Treatment groups

76 Participants

are divided into 2 treatment groups

Group A: Almond Diet GroupExperimental treatment 1 intervention

Group B: Usual Diet ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

Vitamin E

alpha-tocopherol measured in blood

Time frame

8 weeks

Diet Quality

Healthy Eating Index assessed with the Remote Food Photography Method and SmartIntake app

Time frame

8 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pennington Biomedical Research Center

Lead sponsor

Almond Board of California

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: