ObesityNCT07796204
Ability of Almonds to Improve Nutrition During GLP-1 Treatment
A study testing Almond Diet in people with Obesity and Type 2 Diabetes, run by Pennington Biomedical Research Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity, Type 2 Diabetes
- What is being tested?
- Almond Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2026to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70806
About this study
Official title: 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.
- Conditions
- Obesity, Type 2 Diabetes
- Being tested
- Almond Diet
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Almond DietOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin E
alpha-tocopherol measured in blood
Measured: 8 weeks
Diet Quality
Healthy Eating Index assessed with the Remote Food Photography Method and SmartIntake app
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start3 Sep 2026 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Almond Board of California
- Responsible party
- Principal investigator, Corby K. Martin, Pennington Biomedical Research Center
- Investigators
- Corby K Martin, PhD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07796204
- Sponsor's protocol ID
- 2026-038-PBRC
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Ability of Almonds to Increase Vitamin E (Alpha-tocopherol) and Diet Quality During GLP-1 Treatment: A Randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT07796204
- Acronym / sponsor ID
- 2026-038-PBRC
- Conditions
- Obesity, Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- Almond Board of California
- Study start
- 3 Sep 2026 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Almond Diet Group | Experimental | Other: Almond DietThis 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. |
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Almond DietParticipants 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. | Other | Almond Diet Group |
Primary outcome
Vitamin E
Time frame: 8 weeks
alpha-tocopherol measured in blood
Diet Quality
Time frame: 8 weeks
Healthy Eating Index assessed with the Remote Food Photography Method and SmartIntake app
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Corby K Martin, PhD principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Almond Diet in people with Obesity and Type 2 Diabetes, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Corby K Martin, PhD (225-763-2585, corby.martin@pbrc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitamin E (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.