- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Nevada
-
Las Vegas, Nevada, États-Unis, 89101
- Citruslabs
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Healthy Metabolism Support
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Self-Reported Energy
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 20746
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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