A Clinical Trial to Evaluate the Effects of a Supplement on Supporting Signs of a Healthy Metabolism
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Love Wellness
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change in Healthy Metabolism Support
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Be female.
- •Be aged 25-
- •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.
Arms & Interventions
Love Wellness Energize
Intervention: Love Wellness Energize (Dietary Supplement)
Outcomes
Primary Outcomes
Change in Healthy Metabolism Support
Time Frame: Baseline, Week 1, Week 2, Week 3, and Week 4
Self-reported perception of metabolism support, assessed via self-reported questionnaire
Secondary Outcomes
- Change in Self-Reported Energy(Baseline, Week 1, Week 2, Week 3, and Week 4)
- Change in Self-Reported Bloating After Hydration(Baseline, Week 1, Week 2, Week 3, and Week 4)
- Change in Self-Reported Weight Management Support(Baseline, Week 1, Week 2, Week 3, and Week 4)