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A Clinical Trial to Evaluate the Effects of a Powder Supplement in Supporting Lean Muscle Development, Hormone-Related Wellness, Digestive Comfort, Dermatologic Health, and Overall Wellness

11 августа 2026 г. обновлено: Clean Nutraceuticals

This study will evaluate the effects of Clean Nutra's Shelf Builder Women's Creatine Powder on lean muscle development, hormone-related wellness, digestive comfort, dermatological health, and overall wellness. The study is a single-arm, open-label, virtual trial in which all 35 enrolled participants will use the test product once daily for eight weeks.

Participants will complete self-reported questionnaires at Baseline and at the end of Week 4 and Week 8 to assess changes in lean muscle development, muscular endurance, hormone-related wellness, digestive comfort, hair/nail/skin health, and overall wellness.

Обзор исследования

Статус

Рекрутинг

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Оцененный)

35

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

Места учебы

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый

Принимает здоровых добровольцев

Да

Описание

Inclusion Criteria:

  • Be female.
  • Be aged 21-45.
  • Engages in structured physical activity ≥3 times per week, with each session lasting at least 30 minutes, (e.g., running, gym/strength training, cycling, team sports, fitness classes).
  • Anyone with a menstrual cycle between 24-38 days.
  • Anyone who has experienced concerns with at least two of the following, twice per week, over the past four weeks: Hair, skin, and nail health
  • Bloating
  • Symptoms of hormonal imbalance.
  • Anyone with a BMI of 18.5 to 30 kg/m2.
  • Anyone who is generally healthy - does not live with any uncontrolled chronic disease.
  • If taking medications, other supplements, or herbal remedies targeted at lean muscle development, muscular endurance, digestive comfort, hormonal balance, or dermatological health, has been consistently taking for at least three months prior to starting the study, and is willing to maintain this routine for the study duration.
  • Anyone who is willing to maintain their current diet, sleep pattern, and activity levels for the duration of the trial.
  • Resides in the United States.

Exclusion Criteria:

  • Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and mental health disorders.
  • Anyone with a known history of severe digestive disorders like acid reflux, Irritable Bowel Syndrome (IBS), Irritable Bowel Disease (IBD), Crohn's disease, or gastrointestinal tract surgeries.
  • Planning on introducing any products or any new forms of prescription medication or supplements that target lean muscle development, muscular endurance, digestive comfort, hormonal balance, or dermatological health for the study duration.
  • Anyone who has been diagnosed with kidney disease and/or has previously or is currently taking diuretics or kidney medications.
  • Anyone who has previously or is currently taking any hormone therapies.
  • Anyone who is currently taking medications or supplements that contain zinc or iron.
  • Anyone with any allergies or sensitivities to fish, eggs, or any of the study product ingredients.
  • Anyone currently consuming products with creatine.
  • Anyone diagnosed with a thyroid-related condition.
  • Any women who are pregnant, breastfeeding, or trying to conceive (or who will be at any point during the study period).
  • Anyone who has a history of serious illness in the last three months.
  • Anyone who has planned surgery during the study period.
  • Anyone with a history of substance abuse.
  • Anyone who is currently a smoker or has been a smoker in the past 3 months.
  • Anyone who has stopped or started using hormonal birth control in the past 2 months.
  • Anyone who is vegan and/or does not consume animal products for any reason.
  • Anyone currently taking a weight loss medication, including but not limited to Wegovy, Mounjaro, and Ozempic.
  • Currently undergoing hair treatment or using other hair growth/thickening products.
  • Currently taking any prescription medication for hair loss.
  • Anyone with any conditions that affect the hair or scalp (e.g., alopecia areata).
  • Anyone who drinks heavily (8 or more alcoholic drinks per week).

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Другой
  • Распределение: Н/Д
  • Интервенционная модель: Одногрупповое задание
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Shelf Builder Women's Creatine Powder
Диетическая добавка: Shelf Builder Women's Creatine Powder
All participants take one scoop (9 g) of Clean Nutra Shelf Builder Women's Creatine Powder mixed in 8 oz of cold water once daily with the first meal of the day for eight weeks.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change in Lean Muscle Development
Временное ограничение: Baseline, Week 4, and Week 8
Self-reported change in lean muscle development assessed via questionnaire
Baseline, Week 4, and Week 8
Change in Muscular Endurance
Временное ограничение: Baseline, Week 4, and Week 8
Self-reported change in muscular endurance assessed via questionnaire
Baseline, Week 4, and Week 8
Change in Digestive Comfort
Временное ограничение: Baseline, Week 4, and Week 8
Self-reported change in digestive comfort assessed via questionnaire
Baseline, Week 4, and Week 8
Change in Hair
Временное ограничение: Baseline, Week 4, and Week 8
Self-reported change in hair, nail, and skin health assessed via questionnaire
Baseline, Week 4, and Week 8
Change in Nail
Временное ограничение: Baseline, Week 4, and Week 8
Self-reported change in hair, nail, and skin health assessed via questionnaire
Baseline, Week 4, and Week 8
Change in Skin Health
Временное ограничение: Baseline, Week 4, and Week 8
Self-reported change in hair, nail, and skin health assessed via questionnaire
Baseline, Week 4, and Week 8
Change in Symptoms of Hormonal Imbalance
Временное ограничение: Baseline, Week 4, and Week 8
Self-reported change in symptoms of hormonal imbalance assessed via questionnaire
Baseline, Week 4, and Week 8
Change in Overall Health and Wellness
Временное ограничение: Baseline, Week 4, and Week 8
Self-reported change in overall health and wellness assessed via questionnaire
Baseline, Week 4, and Week 8

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Perceived Change in Lean Muscle Strength
Временное ограничение: Baseline, Week 4, and Week 8
Participant-perceived change in lean muscle strength assessed via self-reported questionnaire
Baseline, Week 4, and Week 8
Perceived Change in Exercise Performance
Временное ограничение: Baseline, Week 4, and Week 8
Participant-perceived change in exercise performance assessed via self-reported questionnaire
Baseline, Week 4, and Week 8
Perceived Change in Lean Muscle Development
Временное ограничение: Baseline, Week 4, and Week 8
Participant-perceived change in lean muscle development assessed via self-reported questionnaire
Baseline, Week 4, and Week 8
Perceived Change in Hair
Временное ограничение: Baseline, Week 4, and Week 8
Participant-perceived change in hair, nail, and skin health assessed via self-reported questionnaire
Baseline, Week 4, and Week 8
Perceived Change in Nail
Временное ограничение: Baseline, Week 4, and Week 8
Participant-perceived change in hair, nail, and skin health assessed via self-reported questionnaire
Baseline, Week 4, and Week 8
Perceived Change in Skin Health
Временное ограничение: Baseline, Week 4, and Week 8
Participant-perceived change in hair, nail, and skin health assessed via self-reported questionnaire
Baseline, Week 4, and Week 8
Perceived Change in Mood
Временное ограничение: Baseline, Week 4, and Week 8
Participant-perceived change in mood assessed via self-reported questionnaire
Baseline, Week 4, and Week 8
Perceived Change in Energy Levels
Временное ограничение: Baseline, Week 4, and Week 8
Participant-perceived change in energy levels assessed via self-reported questionnaire
Baseline, Week 4, and Week 8
Perceived Change in Mental Clarity
Временное ограничение: Baseline, Week 4, and Week 8
Participant-perceived change in mental clarity assessed via self-reported questionnaire
Baseline, Week 4, and Week 8
Perceived Change in Digestive Health
Временное ограничение: Baseline, Week 4, and Week 8
Participant-perceived change in digestive health assessed via self-reported questionnaire
Baseline, Week 4, and Week 8
Perceived Change in Bloating
Временное ограничение: Baseline, Week 4, and Week 8
Participant-perceived change in bloating assessed via self-reported questionnaire
Baseline, Week 4, and Week 8
Perceived Change in Digestive Comfort
Временное ограничение: Baseline, Week 4, and Week 8
Participant-perceived change in digestive comfort assessed via self-reported questionnaire
Baseline, Week 4, and Week 8
Perceived Change in Muscle Recovery
Временное ограничение: Baseline, Week 4, and Week 8
Participant-perceived change in muscle recovery assessed via self-reported questionnaire
Baseline, Week 4, and Week 8

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Clean Nutraceuticals

Соавторы

Citruslabs

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Оцененный)

1 сентября 2026 г.

Первичное завершение (Оцененный)

1 ноября 2026 г.

Завершение исследования (Оцененный)

1 ноября 2026 г.

Даты регистрации исследования

Первый отправленный

11 августа 2026 г.

Впервые представлено, что соответствует критериям контроля качества

11 августа 2026 г.

Первый опубликованный (Действительный)

14 августа 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

14 августа 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

11 августа 2026 г.

Последняя проверка

1 августа 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Другие идентификационные номера исследования

  • 20834
  • legacy-20834

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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