Ability of Almonds to Improve Nutrition During GLP-1 Treatment
The Ability of Almonds to Increase Vitamin E (Alpha-tocopherol) and Diet Quality During GLP-1 Treatment: A Randomized Controlled Pilot Trial
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 70 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This 8-week study tests whether eating almonds raises vitamin E levels in the blood and improves diet quality in adults starting injectable semaglutide or tirzepatide. It is for adults with type 2 diabetes or obesity who meet the study rules. People are placed by chance into two groups: one eats at least 56 grams of almonds each day, and the other eats no almonds and follows their usual diet.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be 18 to 70 years old.
- Have a BMI of 27 to 47.5 and type 2 diabetes diagnosed by your doctor, or have a BMI of 30 or higher with obesity and at least a 2-month supply of the medicine. BMI is a measure of weight compared with height.
- Be prescribed brand-name injectable semaglutide or tirzepatide. The study does not provide the medicine.
- Join and finish the starting study tests before starting the medicine.
- Have HbA1c tests at Pennington Biomedical at the start and follow-up. This test measures average blood sugar; the starting result does not decide if you can join.
- Other medicines are allowed if the study doctor approves.
- Be able and willing to follow all study steps.
Who can't join
- Are pregnant or breastfeeding.
- Take or plan to take a medicine, vitamin, or mineral supplement that affects vitamin E levels.
- Have used a GLP-1 medicine in the past 3 months.
- Have a medical reason you cannot use GLP-1 medicines, or have had a harmful or allergic reaction to one.
- Have a health, mental health, thinking, or other condition that limits your ability to complete study steps.
- Have had weight-loss surgery.
- Are allergic to almonds.
- Have active cancer, except for some skin cancers, or are getting chemotherapy or radiation treatment.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 sites (1)
LA
- Pennington Biomedical Research Center · Baton Rouge, LA 70806More trials in Baton Rouge