- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07765407
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.
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Nevada
-
Las Vegas, Nevada, Stati Uniti, 89101
- Citruslabs
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Healthy Metabolism Support
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Self-Reported Energy
Lasso di tempo: 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
|
Baseline, Week 1, Week 2, Week 3, and Week 4
|
|
Change in Self-Reported Bloating After Hydration
Lasso di tempo: Baseline, Week 1, Week 2, Week 3, and Week 4
|
Participants' perceived effects of the test product on bloating after hydration, assessed via self-reported questionnaire
|
Baseline, Week 1, Week 2, Week 3, and Week 4
|
|
Change in Self-Reported Weight Management Support
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Collaboratori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 20746
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .