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OpenTrials
Completed

NCT Number: NCT06568146

A Single Group Study to Evaluate the Effects of a Multivitamin on a Range of Health and Wellbeing Outcomes.

This is a hybrid single-group clinical trial that will last 12 weeks. Participants will take 2 capsules daily with the first meal of the day in the morning. Participants will undertake blood tests at Baseline and Week 12. Study-specific questionnaires will be completed at Baseline, Week 4, Week 8, and Week 12. Cognitive Battery Testing will take place at Baseline, Week 4, Week 8, and Week 12.

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Key information

Conditions

Health and Wellbeing Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Citruslabs

Santa Monica, California, 90404, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female at birth.
  • Aged 18+.
  • Interested in supporting their health and wellbeing.
  • Not planning to introduce or change prescription medications, vitamins, minerals, or supplements one month prior to and during the study.
  • Generally healthy with no uncontrolled chronic conditions.

Exclusion criteria

  • Recent surgeries or invasive treatments.
  • Introduction of new health-related products in the last 12 weeks.
  • Allergies to product ingredients or use of Epi-Pen.
  • Chronic health conditions affecting participation.
  • Endocrine or glucose-related disorders, including diabetes.
  • Hematological disorders, including anemia.
  • Pregnant, breastfeeding, or planning to conceive.
  • History of substance abuse or recent smoking.
  • Unwillingness to follow the study protocol.
  • Participation in other clinical trials.

Treatment and study plan

Multivitamin supplement

Dietary Supplement

: Participants will take 2 capsules of the multivitamin supplement daily with the first meal of the day in the morning.

Other names: Daily Love Multivitamin

Primary outcomes

  1. Changes in Blood Levels of Vitamin B12

    Time frame: Baseline and Week 12

    This outcome measure will assess the effect of the multivitamin supplement on serum levels of Vitamin B12.

  2. Changes in Blood Levels of Insulin

    Time frame: Baseline and Week 12

    This outcome measure will assess the effect of the multivitamin supplement on serum levels of Insulin.

  3. Changes in Blood Levels of Vitamin D

    Time frame: Baseline and Week 12

    This outcome measure will assess the effect of the multivitamin supplement on serum levels of Vitamin D.

  4. Changes in Blood Levels of Iron

    Time frame: Baseline and Week 12

    This outcome measure will assess the effect of the multivitamin supplement on serum levels of Iron.

Secondary outcomes

  1. Participants' Perceptions of Health and Wellbeing

    Time frame: Baseline, Week 4, Week 8, and Week 12

    Evaluation of participants' perceptions via a questionnaire exploring the convenience and efficacy of the multivitamin supplement in supporting overall health and wellbeing.

Sponsors and collaborators

Lead sponsor

Love Wellness

Industry

Collaborators

  • Citruslabs

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 23, 2024
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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