Pistachio Intake and Nutrition-Related Outcomes in Individuals on GLP-1 Therapy
This study is looking at how eating pistachios every day might affect your weight, diet, and how you feel if you are taking GLP-1 medicines like semaglutide or tirzepatide. Researchers want to see if adding 2 ounces (about 53 grams) of dry-roasted, unsalted pistachios to your daily diet for 12 weeks helps you feel fuller, have more energy, and improves your body composition (the amount of fat and muscle you have). You can join if you are 18 to 80 years old, have a certain body mass index (BMI), and have been continuously using semaglutide or tirzepatide for at least three months. The study will measure changes in how full you feel, your fatigue (tiredness), and your mood/well-being. The current status of this study is unclear, and it plans to enroll 108 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific intervention (eating pistachios). It plans to enroll 108 participants.
- What's involved
- You would eat 2 ounces of dry-roasted, unsalted pistachios daily for 12 weeks. You would also have DEXA scans (a type of X-ray to measure body fat) and complete surveys about satiety (fullness), fatigue, and mood at the beginning and end of the 12-week study.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your satiety, fatigue, and mood will be measured at the end of the 12-week study.
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Pistachio Intake and Nutrition-Related Outcomes in Individuals on GLP-1 Therapy
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Ian Neeland, MD · PRINCIPAL_INVESTIGATOR · University Hospitals Cleveland Medical Center
- Abigail Raffner, MD · PRINCIPAL_INVESTIGATOR · University Hospitals Cleveland Medical Center
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Change is Satiety as measured by the Hunger and Satiety Visual Analog Scales (VAS)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 SurveyBaseline, 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.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)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)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 reviewBaseline, End of study (12 weeks)
- Change in HbA1c as measured by medical record reviewBaseline, End of study (12 weeks)
- Change in total cholesterol as measured by medical record reviewBaseline, End of study (12 weeks)
- Change in LDL-C as measured by medical record reviewBaseline, End of study (12 weeks)
- Change in HDL-C as measured by medical record reviewBaseline, End of study (12 weeks)
- Change in triglycerides as measured by medical record reviewBaseline, End of study (12 weeks)
- Change in physical activity as measured by International Physical Activity Questionnaire (IPAQ)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).