A Clinical Trial to Evaluate the Effects of a Supplement on Supporting Signs of a Healthy Metabolism
This study evaluates the effects of Love Wellness Energize, a dietary supplement, on supporting signs of a healthy metabolism in women aged 25-45 who report poor energy levels, perception of poor metabolism, difficulty with weight management, and feeling bloated. The trial is a single-arm, open-label, virtual study conducted over 4 weeks with 40 female participants.
Participants will dissolve one tablet of the test product in 16 fl.oz/475 mL of water twice daily and complete self-reported questionnaires at Baseline, Week 1, Week 2, Week 3, and Week 4. The primary endpoint is change in metabolism support, and secondary endpoints include perceptions of energy, bloating after hydration, and weight management support.
調査の概要
状態
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Nevada
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Las Vegas、Nevada、アメリカ、89101
- Citruslabs
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参加基準
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
説明
Inclusion Criteria:
- Be female.
- Be aged 25-45.
- Currently experiencing issues regarding all of the following: poor energy levels, perception of poor metabolism, difficulty with weight management, and feeling bloated.
- Generally healthy - does not live with any uncontrolled chronic disease.
- Willing to refrain from taking any products, prescription medications, or supplements that target metabolic health during the test period.
- Willing to maintain their current diet, sleep schedule, and activity level for the study duration.
- Resides in the United States.
Exclusion Criteria:
- Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including cancer, mental health disorders, history of serious illness in the last three months, history of substance abuse, or planned surgery during the study period.
- Anyone diagnosed with and getting treated for Parkinson's disease.
- Anyone taking a prescription diabetes medication including but not limited to GLP-1 receptor agonist medications such as Ozempic, Wegovy, or Mounjaro.
- Anyone who drinks heavily (i.e., 8 or more alcoholic drinks per week for women or 15 or more alcoholic drinks per week for men).
- Any women who are pregnant, breastfeeding, or trying to conceive (or who will be at any point during the study period).
- Anyone testing or planning to test, in the next 4 weeks, a product for another research study.
- Anyone unwilling to follow the study protocol.
- Anyone with any allergies or sensitivities to any of the study product ingredients.
研究計画
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:処理
- 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 |
|---|---|
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実験的:Love Wellness Energize
|
All participants dissolve one tablet of Love Wellness Energize in 16 fl.oz/475
mL of water twice daily at 11 am and 3 pm (or after planned exercise) for 4 weeks.
Ingredients include Vitamin B1 15 mg, Vitamin B3 30 mg, Vitamin B6 10 mg, Vitamin B12 250 mcg, Calcium 100 mg, Magnesium 60 mg, Chromium 200 mcg, Sodium 310 mg, and Potassium 200 mg, among other excipients.
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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 Healthy Metabolism Support
時間枠:Baseline, Week 1, Week 2, Week 3, and Week 4
|
Self-reported perception of metabolism support, assessed via self-reported questionnaire
|
Baseline, Week 1, Week 2, Week 3, and Week 4
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Self-Reported Energy
時間枠:Baseline, Week 1, Week 2, Week 3, and Week 4
|
Participants' perceived effects of the test product on energy levels, assessed via self-reported questionnaire
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Baseline, Week 1, Week 2, Week 3, and Week 4
|
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Change in Self-Reported Bloating After Hydration
時間枠:Baseline, Week 1, Week 2, Week 3, and Week 4
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Participants' perceived effects of the test product on bloating after hydration, assessed via self-reported questionnaire
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Baseline, Week 1, Week 2, Week 3, and Week 4
|
|
Change in Self-Reported Weight Management Support
時間枠:Baseline, Week 1, Week 2, Week 3, and Week 4
|
Participants' perceived effects of the test product on weight management support, assessed via self-reported questionnaire
|
Baseline, Week 1, Week 2, Week 3, and Week 4
|
協力者と研究者
スポンサー
協力者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 20746
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
米国FDA規制機器製品の研究
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。