- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07755475
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Nevada
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Las Vegas, Nevada, Verenigde Staten, 89101
- Citruslabs
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: 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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Cognitive Battery Test Score (Polygons)
Tijdsspanne: 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)
Tijdsspanne: 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
|
|
Change in Cognitive Battery Test Score (Feature Match)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: Baseline and Week 4
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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)
Tijdsspanne: 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
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Baseline and Week 4
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Self-Reported Mental Clarity and Focus
Tijdsspanne: Baseline, Week 1, Week 2, Week 3, and Week 4
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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 Alertness
Tijdsspanne: Baseline, Week 1, Week 2, Week 3, and Week 4
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Assessed via self-reported questionnaire
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Baseline, Week 1, Week 2, Week 3, and Week 4
|
|
Change in Self-Reported Mood
Tijdsspanne: 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
Tijdsspanne: 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 Overall Energy Levels
Tijdsspanne: 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
|
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Change in Self-Reported Frequency of Food Cravings
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 20772
- legacy-20772
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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