Body Confidence, Gut Health, Metabolic Health, Weight Management
Conditions
Brief summary
This study evaluates the effects of the Love Wellness supplement Hello Burn Activate on supporting metabolic health in adult females. The 12-week, single-arm, open-label, virtual trial will enroll 40 female participants aged 25-45 who are experiencing challenges with healthy weight management and body confidence. All participants will take one capsule of the test product daily in the morning with their first meal. Participants will complete self-reported questionnaires at Baseline, Week 4, Week 8, and Week 12 to assess changes in perceived metabolic health, body confidence, overall health, and well-being.
Interventions
DIETARY_SUPPLEMENTHello Burn Activate
All enrolled participants take one capsule of Hello Burn Activate (containing heat-treated Bifidobacterium animalis lactis BPL1, inulin, vegetable capsule \[hypromellose, water\], and medium chain triglycerides) once daily in the morning with the first meal of the day for 12 weeks.
Sponsors
Love Wellness
Citruslabs
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Be female. * Be aged 25-45. * Currently experiencing issues regarding healthy weight management. * Currently experiencing issues regarding body confidence. * Currently experiencing difficulty maintaining a weight management routine. * 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 duration of the study. * 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 taking a prescription GLP-1 medication, including but not limited to Ozempic, Wegovy, or Mounjaro. * Anyone taking a prescription anticoagulant ('blood thinner') medication. * Anyone taking a prescription antibiotic. * 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 participating in another research study within the next 12 weeks. * Anyone unwilling to follow the study protocol. * Anyone with any allergies or sensitivities to any of the study product ingredients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Perceived Metabolic Health | Baseline, Week 4, Week 8, and Week 12 | Self-reported assessment of overall metabolic health via self-reported questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Confidence | Baseline, Week 4, Week 8, and Week 12 | Self-reported assessment of body confidence via self-reported questionnaire |
| Change in Overall Well-Being | Baseline, Week 4, Week 8, and Week 12 | Self-reported assessment of overall well-being via self-reported questionnaire |
| Change in Overall Health | Baseline, Week 4, Week 8, and Week 12 | Self-reported assessment of overall health via self-reported questionnaire |
Countries
United States
Outcome results
None listed