University Hospitals Cleveland Medical Center
Clevland, Ohio, 44106, United States
Location status: Recruiting
Location contact
Abigail Raffner, PhD, RD, LD
CONTACT
Ian Neeland, MD
CONTACT
NCT Number: NCT07244458
This study will look at how eating peanuts every day might affect participants weight, how healthy their diet is, and how they feel when eating. Investigators want to see if adding peanuts 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 peanuts improves overall diet quality and health markers like tiredness and certain levels in blood.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Clevland, Ohio, 44106, United States
Location status: Recruiting
Abigail Raffner, PhD, RD, LD
CONTACT
Ian Neeland, MD
CONTACT
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will eat 2 ounces, or about 53 grams, of dry-roasted, lightly salted peanuts each day along with their regular diet
DEXA scans will be used to measure body fat
Time frame: 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.
Time frame: 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.
Time frame: 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".
Time frame: 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.
Time frame: 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").
Time frame: Baseline, End of study (12 weeks)
Time frame: Baseline, End of study (12 weeks)
Time frame: Baseline, End of study (12 weeks)
Time frame: Baseline, End of study (12 weeks)
Time frame: Baseline, End of study (12 weeks)
Time frame: Baseline, End of study (12 weeks)
Time frame: 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).
Time frame: Baseline, End of study (12 weeks)
Time frame: Baseline, End of study (12 weeks)
Time frame: Baseline, End of study (12 weeks)
Time frame: Baseline, End of study (12 weeks)
Time frame: Baseline, End of study (12 weeks)
Time frame: Baseline, End of study (12 weeks)
Contact information is provided by the study sponsor or research team.
Abigail Raffner, PhD, RD, LD
CONTACT
Ian Neeland, MD
CONTACT
Ian J. Neeland, MD
Other
Dietary Peanut Intake and Nutrition-Related Outcomes in Individuals Using GLP-1 Receptor Agonists: A Randomized Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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