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

11. august 2026 oppdatert av: Love Wellness

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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

40

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Nevada
      • Las Vegas, Nevada, Forente stater, 89101
        • Citruslabs

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Hello Burn, Balance Supplement
Kosttilskudd: Hello 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Symptoms Associated with Hormone Imbalance
Tidsramme: 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
Baseline, First Use (within 1-3 hours of use), Week 1, Week 2, Week 3, and Week 4

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Love Wellness

Samarbeidspartnere

Citruslabs

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

24. februar 2025

Primær fullføring (Faktiske)

17. april 2025

Studiet fullført (Faktiske)

17. april 2025

Datoer for studieregistrering

Først innsendt

11. august 2026

Først innsendt som oppfylte QC-kriteriene

11. august 2026

Først lagt ut (Faktiske)

14. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 20688
  • legacy-20688

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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