The Ability of Almonds to Increase Vitamin E (Alpha-tocopherol) and Diet Quality During GLP-1 Treatment: A Randomized Controlled Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Vitamin E
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Almond Diet (Other)
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.
结局指标
主要结局
Vitamin E
时间窗: 8 weeks
alpha-tocopherol measured in blood
Diet Quality
时间窗: 8 weeks
Healthy Eating Index assessed with the Remote Food Photography Method and SmartIntake app
次要结局
未报告次要终点
研究者
Corby K. Martin
Professor, Director, Ingestive Behavior Laboratory
Pennington Biomedical Research Center