- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07765394
A Clinical Trial to Evaluate the Effects of A Supplement on Supporting Signs of Metabolic Health
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Nevada
-
Las Vegas, Nevada, United States, 89101
- Citruslabs
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Hello 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Perceived Metabolic Health
Time Frame: Baseline, Week 4, Week 8, and Week 12
|
Self-reported assessment of overall metabolic health via self-reported questionnaire
|
Baseline, Week 4, Week 8, and Week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Body Confidence
Time Frame: Baseline, Week 4, Week 8, and Week 12
|
Self-reported assessment of body confidence via self-reported questionnaire
|
Baseline, Week 4, Week 8, and Week 12
|
|
Change in Overall Well-Being
Time Frame: Baseline, Week 4, Week 8, and Week 12
|
Self-reported assessment of overall well-being via self-reported questionnaire
|
Baseline, Week 4, Week 8, and Week 12
|
|
Change in Overall Health
Time Frame: Baseline, Week 4, Week 8, and Week 12
|
Self-reported assessment of overall health via self-reported questionnaire
|
Baseline, Week 4, Week 8, and Week 12
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 20745
- legacy-20745
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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