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Not yet recruitingNCT07796204Updated Sep 1, 2026

Ability of Almonds to Improve Nutrition During GLP-1 Treatment

An interventional study of Almond Diet in Obesity and Type 2 Diabetes, sponsored by Pennington Biomedical Research Center. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-01.

Sponsored by Pennington Biomedical Research Center · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Obesity
  • Type 2 Diabetes
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
76 participants (estimated)

Study arms

  • 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

  • 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.

Interventions

  • OtherAlmond 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.

05

What researchers measure

Primary outcomes

  1. Vitamin E

    alpha-tocopherol measured in blood

    Time frame: 8 weeks

  2. Diet Quality

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

    Time frame: 8 weeks

06

Study locations

1 site
  • Pennington Biomedical Research Center
    Baton Rouge, Louisiana 70806, United States
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07796204
Lead sponsor
Pennington Biomedical Research Center
Collaborators
Almond Board of California
Responsible party
Corby K. Martin (Professor, Director, Ingestive Behavior Laboratory, Pennington Biomedical Research Center) — Principal investigator
First posted
Sep 1, 2026
Start date
Sep 3, 2026 (estimated)
Primary completion
Jun 1, 2028 (estimated)
Completion
Dec 1, 2028 (estimated)
Last update
Sep 1, 2026

Study contacts

Corby K Martin, PhD
Contact
corby.martin@pbrc.edu
225-763-2585
Corby K Martin, PhD
principal investigator · Pennington Biomedical Research Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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