Pistachio Intake and Nutrition-Related Outcomes in Individuals on GLP-1 Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorIan J. Neeland, MD
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
No use or contraindication to use of a GLP-1 RA
Known allergy to nuts
Pregnant or breastfeeding
Incarcerated
Trial design
Design model
Parallel
Treatments tested in this trial
Pistachios
Dietary supplementParticipants will eat 2 ounces, or about 53 grams, of dry-roasted, unsalted pistachios each day along with their regular diet
Dual-energy X-ray absorptiometry (DEXA) scans
Procedure/SurgeryDEXA scans will be used to measure body fat
Treatment groups
108 Participants
are divided into 2 treatment groupsGroup A: Pistachio GroupExperimental treatment 2 interventions
Group B: No Pistachio GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change is Satiety as measured by the Hunger and Satiety Visual Analog Scales (VAS)
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.
Time frame
Baseline, End of study (12 weeks)2
Change in fatigue as measured by the Fatigue Severity VAS-F Survey
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.
Time frame
Baseline, End of study (12 weeks)3
Change in mood/well-being as measured by the Mental clarity, energy levels, and motivation VAS.
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".
Time frame
Baseline, End of study (12 weeks)4
Change in dietary quality as measured by Healthy Eating Index (HEI)
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.
Time frame
Baseline, End of study (12 weeks)Secondary outcomes
1
Change in body weight as measured by medical record review
Time frame
Baseline, End of study (12 weeks)2
Change in waist circumference as measured by medical record review
Time frame
Baseline, End of study (12 weeks)3
Change in hip circumference as measured by medical record review
Time frame
Baseline, End of study (12 weeks)4
Change in fat mass as measured by DEXA scan
Time frame
Baseline, End of study (12 weeks)Locations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
University Hospitals Cleveland Medical CenterRecruiting44106, Clevland, Ohio
United States
United StatesSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ian J. Neeland, MD
Lead sponsor
University Hospitals Cleveland Medical Center
Sponsor institution
Source ClinicalTrials.gov