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Идёт набор NCT07442864

Hunger Perception and Weight-Related Outcomes Following Use of a Leptin-Supporting Dietary Supplement

Без фазы С лечением Hunger Weight Change

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Leptin Balance Formula.
Кому может быть актуально
Состояния в реестре: Hunger, Weight Change. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Evaluation of Hunger Perception and Weight-Related Outcomes Following Use of a Leptin-Supporting Dietary Supplement Over 12 Weeks

Обзор

This study evaluates changes in hunger perception and body composition-related measures following daily use of a commercially available dietary supplement formulated to support leptin-related metabolic signaling. Adult participants will self-administer the supplement for 12 weeks and complete periodic self-reported assessments related to appetite, hunger, and weight-related outcomes. Participants serve as their own control, with comparisons made between baseline and follow-up measurements. The study is designed to generate preliminary, real-world evidence regarding supplement use in a general wellness context.

Подробное описание

Leptin is a hormone involved in appetite regulation and satiety signaling. Dysregulation of leptin signaling has been associated with altered hunger perception and weight management challenges. While diet and physical activity are commonly emphasized in weight optimization strategies, hormonal contributors such as leptin are less frequently evaluated in real-world consumer settings.

This single-arm, observational study is designed to explore changes in hunger perception and weight-related outcomes associated with daily use of the Leptin Balance Formula, a commercially available dietary supplement containing African mango seed extract, chromium picolinate, Ceylon cinnamon, and alpha lipoic acid. Participants will use the product for 12 weeks and complete electronic surveys and self-reported measurements at baseline and designated follow-up time points.

The study is conducted under Efforia's Minimal Risk Umbrella Protocol and is intended as a signal-detection study to inform future, more controlled research designs. The study does not diagnose, treat, or prevent disease and is limited to general health and wellness outcomes.

Study Design

Study Type: Observational

Observational Model: Single Group Assignment

Time Perspective: Prospective

Number of Arms: 1

Masking: None (Open Label)

Primary Purpose: Other (Wellness / Signal Detection)

More information can be found at the study recruitment landing page: https://app.efforia.com/leptin-balance-formula-weight-optimization/

Вмешательства

  • Пищевая добавка Leptin Balance Formula
    Participants will self-administer the Leptin Balance Formula daily for 12 weeks according to product labeling. The supplement is commercially available and includes African mango seed extract, chromium picolinate, Ceylon cinnamon, and alpha lipoic acid.

Первичные конечные точки

  • Change in Hunger Perception [Срок оценки: Baseline and Week 12]
Вторичные конечные точки (2)
  • Change in Body Weight [Срок оценки: Baseline and Week 12]
  • After-Meal Hunger and Fatigue Perception [Срок оценки: Baseline, Week 4, Week 8, and Week 12]

Критерии участия

Критерии включения

  • Adults aged 18 years or older
  • Willing to pay for study supplies and able to take the dietary supplement daily for 12 weeks
  • Willing to complete electronic questionnaires and self-reported measurements
  • Able to provide informed consent

Критерии исключения

  • Pregnant or breastfeeding individuals
  • Known allergy or sensitivity to any supplement ingredients
  • Use of medications or supplements that could interfere with appetite or weight without medical clearance
  • Any medical condition that would make participation unsafe, as determined by the participant

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Организация здравоохранения

Центры проведения

США · 1 центр
  • Efforia — New York

Идентификаторы

NCT: NCT07442864 · 43484

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗