Health and Wellbeing
Conditions
Keywords
Multivitamin, Cognitive Function, Iron, Vitamin D, Vitamin B12, Insulin
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.
Interventions
: Participants will take 2 capsules of the multivitamin supplement daily with the first meal of the day in the morning.
Sponsors
Study design
Masking description
This is an open-label study where no masking will be implemented.
Intervention model description
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.
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Blood Levels of Insulin | Baseline and Week 12 | This outcome measure will assess the effect of the multivitamin supplement on serum levels of Insulin. |
| Changes in Blood Levels of Vitamin B12 | Baseline and Week 12 | This outcome measure will assess the effect of the multivitamin supplement on serum levels of Vitamin B12. |
| Changes in Blood Levels of Vitamin D | Baseline and Week 12 | This outcome measure will assess the effect of the multivitamin supplement on serum levels of Vitamin D. |
| Changes in Blood Levels of Iron | Baseline and Week 12 | This outcome measure will assess the effect of the multivitamin supplement on serum levels of Iron. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants' Perceptions of Health and Wellbeing | 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. |
Countries
United States