Dietary Peanuts and Nutrition-Related Outcomes

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Change is Satiety as measured by the Hunger and Satiety Visual Analog Scales (VAS) [Срок оценки: Baseline, End of study (12 weeks)]
• Change in fatigue as measured by the Fatigue Severity VAS-F Survey [Срок оценки: Baseline, End of study (12 weeks)]
• Change in mood/well-being as measured by the Mental clarity, energy levels, and motivation VAS. [Срок оценки: Baseline, End of study (12 weeks)]
• Change in dietary quality as measured by Healthy Eating Index (HEI) [Срок оценки: Baseline, End of study (12 weeks)]
• Change in food enjoyment as measured by the Food Pleasure Scale (FPS) [Срок оценки: Baseline, End of study (12 weeks)]
• Change in fasting glucose as measured by medical record review [Срок оценки: Baseline, End of study (12 weeks)]
• Change in HbA1c as measured by medical record review [Срок оценки: Baseline, End of study (12 weeks)]
• Change in total cholesterol as measured by medical record review [Срок оценки: Baseline, End of study (12 weeks)]
• Change in LDL-C as measured by medical record review [Срок оценки: Baseline, End of study (12 weeks)]
• Change in HDL-C as measured by medical record review [Срок оценки: Baseline, End of study (12 weeks)]

Вторичные конечные точки (6)

• Change in body weight as measured by medical record review [Срок оценки: Baseline, End of study (12 weeks)]
• Change in waist circumference as measured by medical record review [Срок оценки: Baseline, End of study (12 weeks)]
• Change in hip circumference as measured by medical record review [Срок оценки: Baseline, End of study (12 weeks)]
• Change in fat mass as measured by DEXA scan [Срок оценки: Baseline, End of study (12 weeks)]
• Change in lean body mass as measured by DEXA scan [Срок оценки: Baseline, End of study (12 weeks)]
• Change in overall body fat percentage as measured by DEXA scan [Срок оценки: Baseline, End of study (12 weeks)]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• University Hospitals Cleveland Medical Center — Clevland

Идентификаторы

NCT: NCT07244458 · STUDY20250426

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗