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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

2026年8月11日 更新者：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.

調査の概要

状態

募集

条件

介入・治療

研究の種類

介入

入学 (推定)

35

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • アメリカ
    • Nevada
      • Las Vegas、Nevada、アメリカ、89101
        • 募集
        • Citruslabs

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人

健康ボランティアの受け入れ

はい

説明

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).

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：他の
  • 割り当て：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：Shelf Builder Women's Creatine Powder
ダイエットサプリメント：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in Lean Muscle Development
時間枠：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
時間枠：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
時間枠：Baseline, Week 4, and Week 8
Self-reported change in digestive comfort assessed via questionnaire
Baseline, Week 4, and Week 8
Change in Hair
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Baseline, Week 4, and Week 8
Self-reported change in overall health and wellness assessed via questionnaire
Baseline, Week 4, and Week 8

二次結果の測定

結果測定
メジャーの説明
時間枠
Perceived Change in Lean Muscle Strength
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Baseline, Week 4, and Week 8
Participant-perceived change in muscle recovery assessed via self-reported questionnaire
Baseline, Week 4, and Week 8

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Clean Nutraceuticals

協力者

Citruslabs

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月1日

一次修了 (推定)

2026年11月1日

研究の完了 (推定)

2026年11月1日

試験登録日

最初に提出

2026年8月11日

QC基準を満たした最初の提出物

2026年8月11日

最初の投稿 (実際)

2026年8月14日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月14日

QC基準を満たした最後の更新が送信されました

2026年8月11日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 20834
  • legacy-20834

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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