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NCT Number: NCT07244458

Dietary Peanuts and Nutrition-Related Outcomes

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.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals with a BMI ≥30 kg/m2 or with a BMI ≥27 kg/m2 with at least one weight-related comorbidity who have been using semaglutide or tirzepatide for a clinical indication or at least 6 months

Exclusion criteria

  • No use or contraindication to use of a GLP-1 RA
  • Known allergy to nuts
  • Pregnant or breastfeeding
  • Incarcerated

Treatment and study plan

Peanuts

Dietary Supplement

Participants will eat 2 ounces, or about 53 grams, of dry-roasted, lightly salted peanuts each day along with their regular diet

Dual-energy X-ray absorptiometry (DEXA) scans

Procedure

DEXA scans will be used to measure body fat

Primary outcomes

  1. Change is Satiety as measured by the Hunger and Satiety Visual Analog Scales (VAS)

    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.

  2. Change in fatigue as measured by the Fatigue Severity VAS-F Survey

    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.

  3. Change in mood/well-being as measured by the Mental clarity, energy levels, and motivation VAS.

    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".

  4. Change in dietary quality as measured by Healthy Eating Index (HEI)

    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.

  5. Change in food enjoyment as measured by the Food Pleasure Scale (FPS)

    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").

  6. Change in fasting glucose as measured by medical record review

    Time frame: Baseline, End of study (12 weeks)

  7. Change in HbA1c as measured by medical record review

    Time frame: Baseline, End of study (12 weeks)

  8. Change in total cholesterol as measured by medical record review

    Time frame: Baseline, End of study (12 weeks)

  9. Change in LDL-C as measured by medical record review

    Time frame: Baseline, End of study (12 weeks)

  10. Change in HDL-C as measured by medical record review

    Time frame: Baseline, End of study (12 weeks)

  11. Change in triglycerides as measured by medical record review

    Time frame: Baseline, End of study (12 weeks)

  12. Change in physical activity as measured by International Physical Activity Questionnaire (IPAQ)

    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).

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)

  5. Change in lean body mass as measured by DEXA scan

    Time frame: Baseline, End of study (12 weeks)

  6. Change in overall body fat percentage as measured by DEXA scan

    Time frame: Baseline, End of study (12 weeks)

Study contacts

Contact information is provided by the study sponsor or research team.

Abigail Raffner, PhD, RD, LD

CONTACT

[email protected]

216-368-0756

Ian Neeland, MD

CONTACT

[email protected]

216-844-5965

Sponsors and collaborators

Lead sponsor

Ian J. Neeland, MD

Other

Registry information

Official study title

Dietary Peanut Intake and Nutrition-Related Outcomes in Individuals Using GLP-1 Receptor Agonists: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Nov 24, 2025
Registry last updated
Apr 23, 2026

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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