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Clinical Trials/NCT07765381
NCT07765381CompletedNot Applicable

A Clinical Trial to Evaluate the Effects of a Supplement on Symptoms Associated With Hormone Imbalance

Love Wellness1 site in 1 country40 enrolledStarted: February 24, 2025Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
Change in Symptoms Associated with Hormone Imbalance
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
N/A
Intervention Model
Single group
Primary Purpose
Treatment
Masking
None (open label)

Eligibility Criteria

Ages
25 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

Arms & Interventions

Hello Burn, Balance Supplement

Experimental

Intervention: Hello Burn, Balance Supplement (Dietary Supplement)

Outcomes

Primary Outcomes

Change in Symptoms Associated with Hormone Imbalance

Time Frame: 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 Outcomes

  • Change in Energy Levels(Baseline, First Use (within 1-3 hours of use), Week 1, Week 2, Week 3, and Week 4)
  • Change in Healthy Eating Choices(Baseline, First Use (within 1-3 hours of use), Week 1, Week 2, Week 3, and Week 4)
  • Change in Perception of Metabolism(Baseline, First Use (within 1-3 hours of use), Week 1, Week 2, Week 3, and Week 4)
  • Product Efficacy Perception(Baseline, First Use (within 1-3 hours of use), Week 1, Week 2, Week 3, and Week 4)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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Identifiers

NCT ID
NCT07765381
Other Study IDs
20688, legacy-20688

Dates

First Submitted
(last month)
First Posted
(last month)
Primary Completion
(last year)
Study Completion
(last year)
Last Verified
(2 months ago)
Last updated
(last month)

Regulatory & Sharing

FDA Regulated Drug
No
FDA Regulated Device
No
Has Results
No

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