HealthyVitals+NCT07145658
Multivitamin for Health and Cognition
A study testing multivitamin in people with Healthy and Cognition, run by Dr Anthony Hobson at 2 sites in United Kingdom.
Trial summary
Multiple factors contribute to poor mental and cognitive health including well-balanced nutrition. This research project will aim to establish whether a the multivitamin Vitals+ is more effective in improving markers of health, well being and cognitive function, in healthy volunteers compared to placebo. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- What is being tested?
- multivitamin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 7 Jul 2025to 14 Jan 2026
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant has provided written informed consent before participating in the study after being given a full description of the study and prior to any study-specific procedures being performed.
- Participant has no significant medical diagnosis (health individuals)
- Participant takes no regular prescription medication
- Participant is not undertaking any restrictive diet (e.g. Carnivore, Low FODMAP)
- Participant agrees to adhere to guidance on fortified food intake for the duration of the study
- Participant is a male or non-pregnant female and is 18-70 years of age
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- If WOCBP participant is willing to adhere to one of the following methods of contraception i) Hormonal contraception e.g. the 'pill' or an implant ii) Intrauterine device (IUD) iii) Intrauterine hormone-releasing system (IUS) iv) Hysterectomy v) Vasectomised partner vi) Sexual abstinence (if it is in line with your preferred and usual lifestyle).
- Participant can communicate well with the Investigator and to comply with the requirements for the entire study.
- Participant has capacity to understand written English.
- Participant has a body mass index (BMI) of 18.5 - 39.9kg/m2 (bounds included).
- Participant agrees to follow all pre-test preparation before L/M-HMBT testing.
Who cannot join
- Participant has consumed nutritional supplement in the past 3 months
- Diagnosis of any current medical condition, except visual impairment and other conditions at the discretion of the investigator
- Participated in a trial of an investigational medical product or medical device in the last 28 days.
- Females who report to be pregnant or lactating
- Prior abdominal surgery
- Unwilling to maintain a stable diet for the duration of the trial.
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- Unable to comply with limiting fortified food intake to <5 portions per week for the duration of the study
- Being in the opinion of the investigator unsuitable
- Insufficient knowledge of English to complete the daily bowel diary and food diary.
- Hypersensitivity to any component of the supplement
- Hypersensitivity or known allergy to lactulose or mannitol.
- Consumption of oral antibiotics in the last 4 weeks.
- NSAIDs for 2 weeks prior to and during the entire 90 day study period. Participant should not be a chronic NSAID user (>1 day/week).
- Gastrointestinal infection in the past 4 weeks.
- IV vitamin/mineral therapy in the past 12 weeks
- Use of medical devices for the purpose of cognitive enhancement, such as neural stimulation, in the 2 weeks prior or during the study period
- Participant is involved in this study as an Investigator, sub-Investigator, study coordinator, other study staff, or Sponsor member.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
The functional gut clinic
London, NW16PU
The functional gut clinic
Manchester, m34bg
About this study
Official title: A Randomised Placebo-controlled Trial Assessing the Effect of Daily Supplementation of a 20-ingrediant Multivitamin, on Markers of Health, Wellbeing and Cognitive Function in Healthy Volunteers
Multiple factors contribute to poor mental and cognitive health including well-balanced nutrition. This research project will aim to establish whether a the multivitamin Vitals+ is more effective in improving markers of health, well being and cognitive function, in healthy volunteers compared to placebo.
The study aims to recruit 36 healthy volunteers for a placebo controlled double blind design. Participants will be screened through a phone call to ensure they meet the appropriate inclusion and exclusion criteria to enter the study before attending the clinic for tests to assess blood based vitamin and minerals levels, cognitive function, well-being questionnaires and tests to look at function of their gut barrier and activity of gut bacteria. They will then take the multi-vitamin or a placebo daily for 3 months before repeating the same tests in a second in person clinic appointment.
- Being tested
- Placebo Capsule(s), multivitamin
- Keywords
- multivitamin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo Capsule(s)Dietary supplement
Placebo - identical capsules containing inert colour matched power
multivitaminDietary supplement
20-ingredient multivitamin
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 90 days placebo capsules 2x daily Receives: Dietary Supplement: Placebo Capsule(s) |
| Multivitamin | Experimental | 90 days multivitamin capsules 2x daily Receives: Dietary Supplement: multivitamin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function score
Mean change in cognition function score from start of study to end of study between multivitamin and placebo groups.
Cognitive function test - a validated, self-administered tool providing a composite score combining subscores of executive function, processing speed, episodic memory, recognition memory and overall dementia risk index. A higher score indicates better cognitive function.
Measured: Start of study to end of study (3 months)
Secondary outcomes (10)
Product safety
Product safety assessed by number of adverse events raised by clinically significant changes in standard haematology and biochemistry panels in the active group.
Measured: start of study to end of study (3 months)
Mean change in The Profile of Mood States questionnaire (POMS)
The Profile of Mood States questionnaire (POMS), is a validated psychological test that contains 65 words and statements that describe feelings. The questionnaire is used to assess changes in mood states overtime, including: Tension, Anger, Fatigue, Depression, Confusion and Vigour. For each word or statement a 5 point Likert scale is utilised to describe the most applicable answer to the word or statement. A total mood disturbance score can be calculated based on the responses.
Measured: Start of study to end of study (3 months)
Mean change in GHQ-12
The General Health Questionnaire-12 (GHQ-12) is a 12-question survey that screens for mental health problems. It is a short version of the original 60-item General Health Questionnaire (GHQ). The questionnaire is often used in the primary care setting and includes questions relating to sleep, tension, temperament, and social functioning difficulties. Each question is measured on a 4 point Likert scale.
Measured: start of study to end of study (3 months)
Serum B12
Comparison of mean change in levels of serum B12 (pg/ml) from start of study to end of study, between active and placebo groups
Measured: start of study to end of study (3 months)
Homocysteine
Comparison of mean change in levels of Homocysteine (umol/L) from start of study to end of study, between active and placebo groups
Measured: start of study to end of study (3 months)
Vitamin B6
Comparison of mean change in levels of Plasma PLP (Vitamin B6)(ug/L) from start of study to end of study, between active and placebo groups
Measured: start of study to end of study (3 months)
Vitamin D
Comparison of mean change in levels of Vitamin D(pmol/L) from start of study to end of study, between active and placebo groups
Measured: start of study to end of study (3 months)
HbA1c
Comparison of mean change in levels of HbA1c (%) from start of study to end of study, between active and placebo groups
Measured: start of study to end of study (3 months)
Iron
Comparison of mean change in levels of Iron (umol/L) from start of study to end of study, between active and placebo groups
Measured: start of study to end of study (3 months)
Riboflavin (Vitamin B2)
Comparison of mean change in levels of Riboflavin (vitamin B2) between active and placebo groups, measured using Erythrocyte glutathione reductase activation coefficient (EGRAC) with a higher value indicating lower riboflavin levels
Measured: Start of study to end of study (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start7 Jul 2025
- Primary completion5 Dec 2025
- Study completion14 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Anthony Hobson
- Sponsor type
- University, hospital or other
- Collaborators
- Heights
- Responsible party
- Sponsor-investigator, Dr Anthony Hobson, The Functional Gut Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07145658
- Sponsor's protocol ID
- FGC-25-01
- Acronym
- Vitals+
- Status last verified
- Mar 2026
- First submitted
- 5 Aug 2025
- Last updated
- 11 Mar 2026
- 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 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Placebo-controlled Trial Assessing the Effect of Daily Supplementation of a 20-ingrediant Multivitamin, on Markers of Health, Wellbeing and Cognitive Function in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT07145658
- Acronym / sponsor ID
- Vitals+ / FGC-25-01
- Keywords
- multivitamin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Dr Anthony HobsonUniversity, hospital or other
- Collaborators
- Heights
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- 5 Dec 2025 (actual)
- Study completion
- 14 Jan 2026 (actual)
- First posted
- 28 Aug 2025 (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.
Multiple factors contribute to poor mental and cognitive health including well-balanced nutrition. This research project will aim to establish whether a the multivitamin Vitals+ is more effective in improving markers of health, well being and cognitive function, in healthy volunteers compared to placebo.
The study aims to recruit 36 healthy volunteers for a placebo controlled double blind design. Participants will be screened through a phone call to ensure they meet the appropriate inclusion and exclusion criteria to enter the study before attending the clinic for tests to assess blood based vitamin and minerals levels, cognitive function, well-being questionnaires and tests to look at function of their gut barrier and activity of gut bacteria. They will then take the multi-vitamin or a placebo daily for 3 months before repeating the same tests in a second in person clinic appointment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo Capsule(s)90 days placebo capsules 2x daily |
| Multivitamin | Experimental | Dietary Supplement: multivitamin90 days multivitamin capsules 2x daily |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Participant has provided written informed consent before participating in the study after being given a full description of the study and prior to any study-specific procedures being performed.
- Participant has no significant medical diagnosis (health individuals)
- Participant takes no regular prescription medication
- Participant is not undertaking any restrictive diet (e.g. Carnivore, Low FODMAP)
- Participant agrees to adhere to guidance on fortified food intake for the duration of the study
Key exclusion criteria (17 listed)
- Participant has consumed nutritional supplement in the past 3 months
- Diagnosis of any current medical condition, except visual impairment and other conditions at the discretion of the investigator
- Participated in a trial of an investigational medical product or medical device in the last 28 days.
- Females who report to be pregnant or lactating
- Prior abdominal surgery
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 |
|---|---|---|
| Placebo Capsule(s)Placebo - identical capsules containing inert colour matched power | Dietary supplement | Placebo |
| multivitamin20-ingredient multivitamin | Dietary supplement | Multivitamin |
Primary outcome
Cognitive function score
Time frame: Start of study to end of study (3 months)
Mean change in cognition function score from start of study to end of study between multivitamin and placebo groups. Cognitive function test - a validated, self-administered tool providing a composite score combining subscores of executive function, processing speed, episodic memory, recognition memory and overall dementia risk index. A higher score indicates better cognitive function.
10 secondary outcomes
Product safety
Time frame: start of study to end of study (3 months)
Mean change in The Profile of Mood States questionnaire (POMS)
Time frame: Start of study to end of study (3 months)
Mean change in GHQ-12
Time frame: start of study to end of study (3 months)
Serum B12
Time frame: start of study to end of study (3 months)
Homocysteine
Time frame: start of study to end of study (3 months)
Vitamin B6
Time frame: start of study to end of study (3 months)
Vitamin D
Time frame: start of study to end of study (3 months)
HbA1c
Time frame: start of study to end of study (3 months)
Iron
Time frame: start of study to end of study (3 months)
Riboflavin (Vitamin B2)
Time frame: Start of study to end of study (3 months)
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 11 Mar 2026.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multivitamin in people with Healthy and Cognition, run by Dr Anthony Hobson at 2 sites in United Kingdom.
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 11 inclusion and 17 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 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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. Some participants in this study may receive a placebo. 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?
Cognitive function score (time frame: Start of study to end of study (3 months)). 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 11 Mar 2026.