Multivitamin for Health and Cognition

NCT07145658 | Completed

• 1 other identifier: FGC-25-01
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Healthy; Cognition; Health

Keywords

multivitamin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Product safety

  start of study to end of study (3 months)

• Mean change in The Profile of Mood States questionnaire (POMS)

  Start of study to end of study (3 months)

• Mean change in GHQ-12

  start of study to end of study (3 months)

• Serum B12

  start of study to end of study (3 months)

• Homocysteine

  start of study to end of study (3 months)

Other Outcomes (2)

• Changes in Intestinal permeability

  start of study to end of study (3 months)

• Correlation between HMBT results and changes in blood-based biomarkers

  start of study to end of study (3 months)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

90 days placebo capsules 2x daily

Dietary Supplement: Placebo Capsule(s)

Multivitamin

EXPERIMENTAL

90 days multivitamin capsules 2x daily

Dietary Supplement: multivitamin

Interventions

Placebo Capsule(s) DIETARY_SUPPLEMENT

Placebo - identical capsules containing inert colour matched power

Placebo

multivitamin DIETARY_SUPPLEMENT

20-ingredient multivitamin

Multivitamin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Dr Anthony Hobson: lead
• Heights: collaborator

Study Sites (2)

The functional gut clinic

London, NW16PU, United Kingdom

Location

The functional gut clinic

Manchester, m34bg, United Kingdom

Location

MeSH Terms

Interventions

Geritol

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Director

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 28, 2025
• Study Start: July 7, 2025
• Primary Completion: December 5, 2025
• Study Completion: January 14, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)