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NCT Number: NCT07796204

Ability of Almonds to Improve Nutrition During GLP-1 Treatment

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70806, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Almond Diet

Other

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.

Primary outcomes

  1. Vitamin E

    Time frame: 8 weeks

    alpha-tocopherol measured in blood

  2. Diet Quality

    Time frame: 8 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Corby K Martin, PhD

CONTACT

[email protected]

225-763-2585

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Collaborators

  • Almond Board of California

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 1, 2026
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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