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

NCT06568146 | Completed

• 1 other identifier: 20432
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Health and Wellbeing

Keywords

Multivitamin; Cognitive Function; Iron; Vitamin D; Vitamin B12; Insulin

Outcome Measures

Primary Outcomes (4)

• Changes in Blood Levels of Vitamin B12

  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

  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

  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

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

  Baseline and Week 12

Secondary Outcomes (1)

• Participants' Perceptions of Health and Wellbeing

  Baseline, Week 4, Week 8, and Week 12

Study Arms (1)

Multivitamin Supplement Group

EXPERIMENTAL

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

Interventions

Multivitamin Supplement DIETARY_SUPPLEMENT

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

Also known as: Daily Love Multivitamin

Multivitamin Supplement Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Love Wellness: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open-label study where no masking will be implemented.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a hybrid single-group clinical trial designed to evaluate the effects of a multivitamin on a range of health and wellbeing outcomes over a 12-week period.

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: August 23, 2024
• Study Start: May 23, 2024
• Primary Completion: October 23, 2024
• Study Completion: October 23, 2024
• Last Updated: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)