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

October 25, 2024 updated by: Love Wellness
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Santa Monica, California, United States, 90404
        • Citruslabs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multivitamin Supplement Group
Participants in this arm will take 2 capsules of the multivitamin supplement daily with the first meal of the day in the morning.
Dietary supplement: Multivitamin 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and Week 12
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.
Baseline and Week 12
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.
Baseline and Week 12
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.
Baseline and Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Week 4, Week 8, and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Love Wellness

Collaborators

Citruslabs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2024

Primary Completion (Actual)

October 23, 2024

Study Completion (Actual)

October 23, 2024

Study Registration Dates

First Submitted

July 11, 2024

First Submitted That Met QC Criteria

August 20, 2024

First Posted (Actual)

August 23, 2024

Study Record Updates

Last Update Posted (Actual)

October 29, 2024

Last Update Submitted That Met QC Criteria

October 25, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20432

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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