Multivitamin for Health and Cognition (Vitals+)

Dr Anthony Hobson

Status: Active, not recruiting

Conditions: Healthy; Health; Cognition

Treatments: Dietary Supplement: Placebo Capsule(s); Dietary Supplement: multivitamin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07145658

FGC-25-01

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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36 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

90 days placebo capsules 2x daily

Treatment:

Dietary Supplement: Placebo Capsule(s)

Multivitamin

Experimental group

Description:

90 days multivitamin capsules 2x daily

Treatment:

Dietary Supplement: multivitamin