Ability of Almonds to Improve Nutrition During GLP-1 Treatment

NCT07796204 | Not Yet Recruiting

• 1 other identifier: 2026-038-PBRC
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity; Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

• Vitamin E

  alpha-tocopherol measured in blood

  8 weeks

• Diet Quality

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

  8 weeks

Study Arms (2)

Almond Diet Group

EXPERIMENTAL

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

Usual Diet Control

NO INTERVENTION

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

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.

Almond Diet Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• Almond Board of California: collaborator

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70806, United States

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Corby K Martin, PhD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Corby K Martin, PhD

CONTACT

225-763-2585; corby.martin@pbrc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director, Ingestive Behavior Laboratory

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: September 1, 2026
• Study Start: September 3, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 1, 2026

Record last verified: 2026-08

Locations

US (1)