Status:
ACTIVE_NOT_RECRUITING
Multivitamin for Health and Cognition
Lead Sponsor:
Dr Anthony Hobson
Collaborating Sponsors:
Heights
Conditions:
Healthy
Cognition
Eligibility:
All Genders
18-70 years
Phase:
NA
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 i...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- 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.
Key Trial Info
Start Date :
July 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT07145658
Start Date
July 7 2025
End Date
December 1 2025
Last Update
December 1 2025
Active Locations (2)
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1
The functional gut clinic
London, United Kingdom, NW16PU
2
The functional gut clinic
Manchester, United Kingdom, m34bg