Multivitamin for Health and Cognition (Vitals+)

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Cognition; Health
• Intervention / Treatment: Dietary supplement: Placebo Capsule(s); Dietary supplement: multivitamin

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, NW16PU
    • The Functional Gut Clinic
  • Manchester, United Kingdom, m34bg
    • The Functional Gut Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. 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.
2. Participant has no significant medical diagnosis (health individuals)
3. Participant takes no regular prescription medication
4. Participant is not undertaking any restrictive diet (e.g. Carnivore, Low FODMAP)
5. Participant agrees to adhere to guidance on fortified food intake for the duration of the study
6. Participant is a male or non-pregnant female and is 18-70 years of age
7. 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).
8. Participant can communicate well with the Investigator and to comply with the requirements for the entire study.
9. Participant has capacity to understand written English.
10. Participant has a body mass index (BMI) of 18.5 - 39.9kg/m2 (bounds included).
11. Participant agrees to follow all pre-test preparation before L/M-HMBT testing.

Exclusion Criteria:

1. Participant has consumed nutritional supplement in the past 3 months
2. Diagnosis of any current medical condition, except visual impairment and other conditions at the discretion of the investigator
3. Participated in a trial of an investigational medical product or medical device in the last 28 days.
4. Females who report to be pregnant or lactating
5. Prior abdominal surgery
6. Unwilling to maintain a stable diet for the duration of the trial.
7. Unable to comply with limiting fortified food intake to <5 portions per week for the duration of the study
8. Being in the opinion of the investigator unsuitable
9. Insufficient knowledge of English to complete the daily bowel diary and food diary.
10. Hypersensitivity to any component of the supplement
11. Hypersensitivity or known allergy to lactulose or mannitol.
12. Consumption of oral antibiotics in the last 4 weeks.
13. 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).
14. Gastrointestinal infection in the past 4 weeks.
15. IV vitamin/mineral therapy in the past 12 weeks
16. Use of medical devices for the purpose of cognitive enhancement, such as neural stimulation, in the 2 weeks prior or during the study period
17. Participant is involved in this study as an Investigator, sub-Investigator, study coordinator, other study staff, or Sponsor member.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 90 days placebo capsules 2x daily	Dietary supplement: Placebo Capsule(s); Placebo - identical capsules containing inert colour matched power
Experimental: Multivitamin; 90 days multivitamin capsules 2x daily	Dietary supplement: multivitamin; 20-ingredient multivitamin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Start of study to end of study (3 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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	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	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	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	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	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	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	Start of study to end of study (3 months)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Intestinal permeability	Two sugars (lactulose/mannitol) are ingested at a controlled amount with ratio in urine samples provided over 3 hours measured to determine gut/barrier dysfunction	start of study to end of study (3 months)
Correlation between HMBT results and changes in blood-based biomarkers	Lactulose Hydrogen Methane Breath Testing (HMBT) is a test utilised clinically to diagnose both Small Intestinal Bacterial Overgrowth (SIBO) and Intestinal Methanogenic Overgrowth (IMO). Total production of hydrogen and methane (area under curve) will also be assessed using this method.	start of study to end of study (3 months)

Collaborators and Investigators

• Sponsor: Dr Anthony Hobson
• Collaborators: Heights

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2025
• Primary Completion (Actual): December 5, 2025
• Study Completion (Actual): January 14, 2026

Study Registration Dates

• First Submitted: August 5, 2025
• First Submitted That Met QC Criteria: August 20, 2025
• First Posted (Actual): August 28, 2025

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: multivitamin
• Additional Relevant MeSH Terms: Geritol
• Other Study ID Numbers: FGC-25-01

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