Hormone Imbalance, Low Energy, Metabolic Symptoms, Thyroid Hormone Imbalance, Unhealthy Eating Habits
Conditions
Brief summary
This study evaluates the effects of the Love Wellness Hello Burn, Balance supplement on symptoms associated with hormone imbalance, as measured by energy levels and healthy eating choices and habits. The trial is a single-arm, open-label, virtual study conducted over 4 weeks, in which all 40 enrolled participants will take the test product daily. Participants will complete self-reported questionnaires at Baseline, after First Use (within 1-3 hours of use), and at Weeks 1, 2, 3, and 4 to assess changes in symptoms associated with hormonal imbalance, energy levels, healthy eating choices and habits, metabolism, and overall product efficacy.
Interventions
DIETARY_SUPPLEMENTHello Burn, Balance Supplement
All participants take 2 capsules of the Love Wellness Hello Burn, Balance supplement once daily in the morning with a glass of water during the first meal of the day for 4 weeks. The supplement contains selenium (as L-selenomethionine) 55 mcg, chromium (as chromium polynicotinate) 35 mcg, Hello Burn Blend (L-carnitine tartrate, organic green tea leaf powder) 1250 mcg, hypromellose capsule, microcrystalline cellulose, and magnesium stearate.
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 No maximum
Healthy volunteers
Yes
Inclusion criteria
* Be female * Be aged 25 or over * Has in the past 4 weeks experienced issues regarding all of the following: difficulty making healthy eating choices and habits, hormonal-driven challenges with healthy eating choices and habits, self-perceived slow metabolism, and low energy * Generally healthy - does not live with any uncontrolled chronic disease * If taking oral over-the-counter supplements or herbal remedies targeted at hormone balance or energy, has been consistently taking these for at least 3 months prior to starting the study and is willing to maintain this routine for the study duration * Willing to refrain from introducing any products or any new forms of prescription medication or supplements that target hormone balance or energy for the study duration * Willing to maintain their diet, sleep schedule, and activity level for the duration of the study * Not currently partaking in another research study and will not be partaking in any other research study for the next 4 weeks and at any point during this study's duration * Resides in the United States
Exclusion criteria
* Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders * Anyone currently taking a prescription thyroid treatment (like levothyroxine) * Anyone with known severe allergic reactions * Anyone with any allergies or sensitivities to any of the study product ingredients * Any women who are pregnant, breastfeeding, or trying to conceive (or who will be at any point during the study period) * Anyone diagnosed with diabetes (type I or type II) * Anyone unwilling to follow the study protocol * Has changed birth control in the past 3 months * Anyone planning to undergo any surgeries or invasive treatments during the study duration * Anyone who has had any major illness in the last 3 months * Anyone with a history of substance abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Symptoms Associated with Hormone Imbalance | Baseline, First Use (within 1-3 hours of use), Week 1, Week 2, Week 3, and Week 4 | Assessed via self-reported questionnaire measuring participant-perceived symptoms associated with hormonal imbalance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Energy Levels | Baseline, First Use (within 1-3 hours of use), Week 1, Week 2, Week 3, and Week 4 | Assessed via self-reported questionnaire measuring participant-perceived energy levels |
| Change in Healthy Eating Choices | Baseline, First Use (within 1-3 hours of use), Week 1, Week 2, Week 3, and Week 4 | Assessed via self-reported questionnaire measuring participant-perceived healthy eating choices and including stress eating |
| Change in Perception of Metabolism | Baseline, First Use (within 1-3 hours of use), Week 1, Week 2, Week 3, and Week 4 | Assessed via self-reported questionnaire measuring participant-perceived metabolic rate |
| Product Efficacy Perception | Baseline, First Use (within 1-3 hours of use), Week 1, Week 2, Week 3, and Week 4 | Assessed via self-reported questionnaire measuring participant perception of the test product's overall efficacy |
Countries
United States
Outcome results
None listed