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Recruiting NCT07244458

Dietary Peanuts and Nutrition-Related Outcomes

No phase Interventional Dietary Change Obesity & Overweight Food Acceptance

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Peanuts, Dual-energy X-ray absorptiometry (DEXA) scans.
Who it may be relevant to
Registry conditions: Dietary Change, Obesity & Overweight, Food Acceptance. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Dietary supplement Peanuts
    Participants will eat 2 ounces, or about 53 grams, of dry-roasted, lightly salted peanuts each day along with their regular diet
  • Procedure Dual-energy X-ray absorptiometry (DEXA) scans
    DEXA scans will be used to measure body fat

Primary outcome measures

  • Change is Satiety as measured by the Hunger and Satiety Visual Analog Scales (VAS) [Time frame: Baseline, End of study (12 weeks)]
  • Change in fatigue as measured by the Fatigue Severity VAS-F Survey [Time frame: Baseline, End of study (12 weeks)]
  • Change in mood/well-being as measured by the Mental clarity, energy levels, and motivation VAS. [Time frame: Baseline, End of study (12 weeks)]
  • Change in dietary quality as measured by Healthy Eating Index (HEI) [Time frame: Baseline, End of study (12 weeks)]
  • Change in food enjoyment as measured by the Food Pleasure Scale (FPS) [Time frame: Baseline, End of study (12 weeks)]
  • Change in fasting glucose as measured by medical record review [Time frame: Baseline, End of study (12 weeks)]
  • Change in HbA1c as measured by medical record review [Time frame: Baseline, End of study (12 weeks)]
  • Change in total cholesterol as measured by medical record review [Time frame: Baseline, End of study (12 weeks)]
  • Change in LDL-C as measured by medical record review [Time frame: Baseline, End of study (12 weeks)]
  • Change in HDL-C as measured by medical record review [Time frame: Baseline, End of study (12 weeks)]
Secondary outcome measures (6)
  • Change in body weight as measured by medical record review [Time frame: Baseline, End of study (12 weeks)]
  • Change in waist circumference as measured by medical record review [Time frame: Baseline, End of study (12 weeks)]
  • Change in hip circumference as measured by medical record review [Time frame: Baseline, End of study (12 weeks)]
  • Change in fat mass as measured by DEXA scan [Time frame: Baseline, End of study (12 weeks)]
  • Change in lean body mass as measured by DEXA scan [Time frame: Baseline, End of study (12 weeks)]
  • Change in overall body fat percentage as measured by DEXA scan [Time frame: Baseline, End of study (12 weeks)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • University Hospitals Cleveland Medical Center — Clevland

Identifiers

NCT: NCT07244458 · STUDY20250426

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗