Dietary Pistachio Intake and Nutrition-Related Outcomes in Individuals Using GLP-1 Receptor Agonists: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Change in HDL-C as measured by medical record review
研究概览
简要总结
In this study will look at how eating pistachios every day might affect participants weight, how healthy their diet is, and how they feel when eating. Investigators want to see if adding pistachios to meals for 12 weeks helps participants feel fuller, have more energy, and improve body composition. The study will include adults who have been taking GLP-1 medicines like semaglutide or tirzepatide for at least three months. Investigators also want to see if eating pistachios improves overall diet quality and health markers like tiredness and certain levels in blood.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals with a BMI ≥30 kg/m2 or with a BMI ≥27 kg/m2 with at least one weight-related comorbidity who have been continuously using semaglutide or tirzepatide for three months for a clinical indication and remain on the therapy at the time of enrollment
排除标准
- •No use or contraindication to use of a GLP-1 RA
- •Known allergy to nuts
- •Pregnant or breastfeeding
- •Incarcerated
研究组 & 干预措施
Pistachio Group
Participants in this group will eat 2 ounces, or 53 grams of dry-roasted, unsalted pistachios each day along with their regular diet.
干预措施: Pistachios (Dietary Supplement)
Pistachio Group
Participants in this group will eat 2 ounces, or 53 grams of dry-roasted, unsalted pistachios each day along with their regular diet.
干预措施: Dual-energy X-ray absorptiometry (DEXA) scans (Procedure)
No Pistachio Group
Participants in this group will continue eating regular diet without pistachios.
干预措施: Dual-energy X-ray absorptiometry (DEXA) scans (Procedure)
结局指标
主要结局
Change in HDL-C as measured by medical record review
时间窗: Baseline, End of study (12 weeks)
Change is Satiety as measured by the Hunger and Satiety Visual Analog Scales (VAS)
时间窗: Baseline, End of study (12 weeks)
Participants will rate their perceived hunger, fullness, and desire to eat on a 100-mm scale, with endpoints ranging from "not at all" to "extremely" for each category.
Change in fatigue as measured by the Fatigue Severity VAS-F Survey
时间窗: Baseline, End of study (12 weeks)
Each item is presented on a 100-mm scale, with endpoints labeled to reflect the extremes of the sensation being measured (e.g., "Not at all tired" to "Extremely tired"). Participants will complete the VAS-F at consistent times of the day to minimize variability. Scores will be recorded both before and after meals to capture potential fluctuations in energy levels.
Change in mood/well-being as measured by the Mental clarity, energy levels, and motivation VAS.
时间窗: Baseline, End of study (12 weeks)
Each item is presented on a 100-mm scale, with endpoints labeled to reflect the extremes of being measured ranging from, for example, "not at all" to "extremely".
Change in dietary quality as measured by Healthy Eating Index (HEI)
时间窗: Baseline, End of study (12 weeks)
HEI scores measure how well a diet aligns with the Dietary Guidelines for Americans. The scores range from 0 to 100, with higher scores indicating foods align with key dietary recommendations and dietary patterns published in the Dietary Guidelines.
Change in food enjoyment as measured by the Food Pleasure Scale (FPS)
时间窗: Baseline, End of study (12 weeks)
The FPS is a validated 21-item tool designed to measure multiple dimensions of food-related enjoyment, including sensory characteristics (appearance, odor, taste, texture), expectations and desires (memories, habits, expectations, choices, needs), and other relevant factors. The importance of each item in relation to general pleasurable experiences of food is rated on a 5-point ordinal scale ranging from 1 ("Not important at all") to 5 ("Extremely important").
Change in fasting glucose as measured by medical record review
时间窗: Baseline, End of study (12 weeks)
Change in HbA1c as measured by medical record review
时间窗: Baseline, End of study (12 weeks)
Change in total cholesterol as measured by medical record review
时间窗: Baseline, End of study (12 weeks)
Change in LDL-C as measured by medical record review
时间窗: Baseline, End of study (12 weeks)
Change in triglycerides as measured by medical record review
时间窗: Baseline, End of study (12 weeks)
Change in physical activity as measured by International Physical Activity Questionnaire (IPAQ)
时间窗: Baseline, End of study (12 weeks)
The IPAQ short form consists of 7 questions designed to assess physical activity levels over the past 7 days in adults. The score is calculated using published guidelines and ranges from 0 to infinity and measures physical activity in median median MET-minutes/week. This is a continuous measure and is calculated as: Total MET-min/week = (Walk METs\*min\*days) + (Moderate activity METs\*min\*days) + Vigorous activity METs\*min\*days).
次要结局
- Change in waist circumference as measured by medical record review(Baseline, End of study (12 weeks))
- Change in hip circumference as measured by medical record review(Baseline, End of study (12 weeks))
- Change in fat mass as measured by DEXA scan(Baseline, End of study (12 weeks))
- Change in lean body mass as measured by DEXA scan(Baseline, End of study (12 weeks))
- Change in overall body fat percentage as measured by DEXA scan(Baseline, End of study (12 weeks))
- Change in body weight as measured by medical record review(Baseline, End of study (12 weeks))
研究者
Ian J. Neeland, MD
Director, UH Center for Cardiovascular Prevention
University Hospitals Cleveland Medical Center