Ability of Almonds to Improve Nutrition During GLP-1 Treatment

August 27, 2026 updated by: Corby K. Martin, Pennington Biomedical Research Center

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70806
        • Pennington Biomedical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Almond Diet Group
This group will be provided with up to 84 grams per day of raw or roasted almonds per day and coached to consume at least 56 grams/day. Participants will be instructed to consume the almonds by replacing snacks, particularly those high in refined carbohydrate, with almonds; integrating almonds into other snacks and meals, etc. 56 grams/day of almonds is equivalent to two servings, which reflects the adult Dietary Guidelines for Americans and is consistent with doses that have been shown to increase alpha-tocopherol levels, and produce beneficial effects on cardiometabolic health and nutrient intake.
Other: Almond Diet
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.
No Intervention: Usual Diet Control
This group will not be provided with any food products and will not receive dietary advice, except being asked to abstain from eating nuts during the 8-week trial. They will receive a weekly phone call from the study team to foster retention and to control the number of contacts between the study team and each of the two groups in the trial.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vitamin E
Time Frame: 8 weeks
alpha-tocopherol measured in blood
8 weeks
Diet Quality
Time Frame: 8 weeks
Healthy Eating Index assessed with the Remote Food Photography Method and SmartIntake app
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pennington Biomedical Research Center

Collaborators

Almond Board of California

Investigators

  • Principal Investigator: Corby K Martin, PhD, Pennington Biomedical Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 3, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

August 27, 2026

First Submitted That Met QC Criteria

August 27, 2026

First Posted (Actual)

September 1, 2026

Study Record Updates

Last Update Posted (Actual)

September 1, 2026

Last Update Submitted That Met QC Criteria

August 27, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-038-PBRC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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