Obesity, Type 2 Diabetes
Conditions
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.
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.
Sponsors
Pennington Biomedical Research Center
Almond Board of California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vitamin E | 8 weeks | alpha-tocopherol measured in blood |
| Diet Quality | 8 weeks | Healthy Eating Index assessed with the Remote Food Photography Method and SmartIntake app |
Countries
United States
Contacts
CONTACTCorby K Martin, PhD
PRINCIPAL_INVESTIGATORCorby K Martin, PhD
Pennington Biomedical Research Center
Outcome results
None listed