Clinical trial

Dietary Peanuts and Nutrition-Related Outcomes

Recruiting now · Not applicable · 1 countries · Registry ID NCT07244458

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 80 Years

SexAll

Healthy volunteersAccepted

ConditionDietary Change, Obesity & Overweight, Food Acceptance

Full registry 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

Treatments and study arms

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

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)

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University Hospitals Cleveland Medical Center🇺🇸 Clevland, Ohio, United States

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Ian Neeland, MDContact

Email · Call 216-844-5965

Abigail Raffner, PhD, RD, LDContact

Email · Call 216-368-0756