A Clinical Trial to Evaluate the Effects of a Supplement on Cognitive Function and Energy Levels
This study evaluates the effects of Artah's Cellular Hydration electrolyte supplement on cognitive function and energy levels in healthy adults aged 25-60 who experience mild to moderate fatigue, brain fog, or related symptoms. The trial is a single-arm, unblinded, virtual study in which all 50 participants will use the test product daily for 4 weeks.
Participants will complete self-reported questionnaires at Baseline, Week 1, Week 2, Week 3, and Week 4, and will undergo cognitive battery testing at Baseline and Week 4. The primary endpoint is change in cognitive performance scores as measured by a standardized cognitive battery. Secondary endpoints include participants' self-reported perceptions of mental clarity, alertness, mood, physical performance, overall energy levels, and frequency of food cravings.
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 male or female.
- Be aged 25-60.
- Anyone currently experiencing mild to moderate issues with at least three of the following: low energy or fatigue
- difficulty concentrating or low mental sharpness
- experiences of brain fog or lack of mental clarity
- feeling of low productivity
- muscle weakness
- unwanted food cravings.
- Undertakes moderate to high-intensity exercise such as jogging/running and/or heavy resistance training at least three times per week.
- Willing to refrain from taking any products, medications, or supplements that target energy, cognition, or physical performance during the test period.
- Anyone with a BMI 18.5 to 30.
- Anyone who has access to a device (e.g., smartphone, laptop, computer) for reliable internet.
- Anyone who is generally healthy - does not live with any uncontrolled chronic disease.
- Anyone willing to maintain a consistent diet and physical activity throughout study duration.
Exclusion Criteria:
- Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
- Anyone suffering from gastrointestinal disorders including but not limited to small intestinal bacterial overgrowth (SIBO), irritable bowel syndrome (IBS), and celiac disease.
- Anyone suffering from hyperkalemia (high potassium), liver disease, or kidney disease.
- Anyone taking ACE inhibitors or potassium-sparing diuretics, examples include: Spironolactone (Aldactone), Eplerenone (Inspra), Amiloride (Midamor), Triamterene (Maxzide), Lisinopril (Zestril, Prinivil), Enalapril (Vasotec), Ramipril (Altace), Benazepril (Lotensin), Quinapril (Accupril), Losartan (Cozaar), Valsartan (Diovan), Olmesartan (Benicar), Irbesartan (Avapro), Lithium carbonate (Lithobid, Eskalith).
- Anyone taking antibiotics.
- Anyone with any allergies or sensitivities to any of the study product ingredients.
- Any women who are pregnant, breastfeeding, or trying to conceive (or who will be at any point during the study period).
- Anyone unwilling to follow the study protocol.
- Anyone with a history of substance abuse.
- Anyone who is a shift worker with an irregular sleep-wake cycle.
- Anyone who drinks heavily (8 or more alcoholic drinks per week for women or 15 or more alcoholic drinks per week for men).
- Anyone who is currently a smoker or has been a smoker in the past 3 months.
- Currently partaking in another research study, or planning to at any point during this study's duration.
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 |
|---|---|
|
アクティブコンパレータ:Cellular Hydration Supplement
|
All 50 participants receive the Artah Cellular Hydration electrolyte supplement taken twice daily (once in the morning before the first meal and once in the afternoon after lunch or before evening exercise) as one teaspoon (approximately 7 g) stirred into 750 ml of water for 4 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 Cognitive Battery Test Score (Polygons)
時間枠:Baseline and Week 4
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Change in processing speed and information sorting ability assessed via the Polygons timed cognitive battery subtest
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Baseline and Week 4
|
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Change in Cognitive Battery Test Score (Double Trouble)
時間枠:Baseline and Week 4
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Change in selective attention and processing speed assessed via the Double Trouble timed cognitive battery subtest (Stroop-based)
|
Baseline and Week 4
|
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Change in Cognitive Battery Test Score (Feature Match)
時間枠:Baseline and Week 4
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Change in focus and processing speed assessed via the Feature Match timed cognitive battery subtest
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Baseline and Week 4
|
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Change in Cognitive Battery Test Score (Paired Associates)
時間枠:Baseline and Week 4
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Change in memory recall assessed via the Paired Associates performance-based cognitive battery subtest
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Baseline and Week 4
|
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Change in Cognitive Battery Test Score (Digit Span)
時間枠:Baseline and Week 4
|
Change in short-term memory and cognitive flexibility assessed via the Digit Span performance-based cognitive battery subtest
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Baseline and Week 4
|
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Change in Cognitive Battery Test Score (Spatial Planning)
時間枠:Baseline and Week 4
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Change in executive function and logical decision-making assessed via the Spatial Planning timed cognitive battery subtest
|
Baseline 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 Mental Clarity and Focus
時間枠:Baseline, Week 1, Week 2, Week 3, and Week 4
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Assessed via self-reported questionnaire
|
Baseline, Week 1, Week 2, Week 3, and Week 4
|
|
Change in Self-Reported Alertness
時間枠:Baseline, Week 1, Week 2, Week 3, and Week 4
|
Assessed via self-reported questionnaire
|
Baseline, Week 1, Week 2, Week 3, and Week 4
|
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Change in Self-Reported Mood
時間枠:Baseline, Week 1, Week 2, Week 3, and Week 4
|
Assessed via self-reported questionnaire
|
Baseline, Week 1, Week 2, Week 3, and Week 4
|
|
Change in Self-Reported Physical Performance
時間枠:Baseline, Week 1, Week 2, Week 3, and Week 4
|
Assessed via self-reported questionnaire
|
Baseline, Week 1, Week 2, Week 3, and Week 4
|
|
Change in Self-Reported Overall Energy Levels
時間枠:Baseline, Week 1, Week 2, Week 3, and Week 4
|
Assessed via self-reported questionnaire
|
Baseline, Week 1, Week 2, Week 3, and Week 4
|
|
Change in Self-Reported Frequency of Food Cravings
時間枠:Baseline, Week 1, Week 2, Week 3, and Week 4
|
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
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。