Health and WellbeingNCT06568146
A Single Group Study to Evaluate the Effects of a Multivitamin on a Range of Health and Wellbeing Outcomes.
A study testing Multivitamin Supplement in people with Health and Wellbeing, run by Love Wellness at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Health and Wellbeing
- What is being tested?
- Multivitamin Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2024to 23 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Pregnant, breastfeeding, or planning to conceive.
- History of substance abuse or recent smoking.
- Unwillingness to follow the study protocol.
- Participation in other clinical trials.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Multivitamin Supplement
- Keywords
- Multivitamin, Cognitive Function, Iron, Vitamin D, Vitamin B12, Insulin
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multivitamin SupplementDietary supplement
Also called Daily Love Multivitamin
: Participants will take 2 capsules of the multivitamin supplement daily with the first meal of the day in the morning.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Multivitamin Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Blood Levels of Vitamin B12
This outcome measure will assess the effect of the multivitamin supplement on serum levels of Vitamin B12.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 12
Secondary outcomes (1)
Participants' Perceptions of Health and Wellbeing
Evaluation of participants' perceptions via a questionnaire exploring the convenience and efficacy of the multivitamin supplement in supporting overall health and wellbeing.
Measured: Baseline, Week 4, Week 8, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start23 May 2024
- Primary completion23 Oct 2024
- Study completion23 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health and WellbeingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Love Wellness
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06568146
- Sponsor's protocol ID
- 20432
- Status last verified
- Oct 2024
- First submitted
- 11 Jul 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Group Study to Evaluate the Effects of a Multivitamin on a Range of Health and Wellbeing Outcomes.
- ClinicalTrials.gov ID
- NCT06568146
- Acronym / sponsor ID
- 20432
- Conditions
- Health and Wellbeing
- Keywords
- Multivitamin, Cognitive Function, Iron, Vitamin D, Vitamin B12, Insulin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Love WellnessIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 23 May 2024 (actual)
- Primary completion
- 23 Oct 2024 (actual)
- Study completion
- 23 Oct 2024 (actual)
- First posted
- 23 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Multivitamin Supplement Group | Experimental | Dietary Supplement: Multivitamin SupplementParticipants in this arm will take 2 capsules of the multivitamin supplement daily with the first meal of the day in the morning. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multivitamin SupplementAlso: Daily Love Multivitamin: Participants will take 2 capsules of the multivitamin supplement daily with the first meal of the day in the morning. | Dietary supplement | Multivitamin Supplement Group |
Primary outcome
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.
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.
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.
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.
1 secondary outcome
Participants' Perceptions of Health and Wellbeing
Time frame: Baseline, Week 4, Week 8, and Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multivitamin Supplement in people with Health and Wellbeing, run by Love Wellness at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Blood Levels of Vitamin B12 (time frame: Baseline and Week 12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.