Placebo Capsule(s)
Dietary SupplementPlacebo - identical capsules containing inert colour matched power
NCT Number: NCT07145658
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.
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Inclusion criteria
Exclusion criteria
Placebo - identical capsules containing inert colour matched power
20-ingredient multivitamin
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.
Time frame: start of study to end of study (3 months)
Product safety assessed by number of adverse events raised by clinically significant changes in standard haematology and biochemistry panels in the active group.
Time frame: Start of study to end of study (3 months)
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.
Time frame: start of study to end of study (3 months)
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.
Time frame: start of study to end of study (3 months)
Comparison of mean change in levels of serum B12 (pg/ml) from start of study to end of study, between active and placebo groups
Time frame: start of study to end of study (3 months)
Comparison of mean change in levels of Homocysteine (umol/L) from start of study to end of study, between active and placebo groups
Time frame: start of study to end of study (3 months)
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
Time frame: start of study to end of study (3 months)
Comparison of mean change in levels of Vitamin D(pmol/L) from start of study to end of study, between active and placebo groups
Time frame: start of study to end of study (3 months)
Comparison of mean change in levels of HbA1c (%) from start of study to end of study, between active and placebo groups
Time frame: start of study to end of study (3 months)
Comparison of mean change in levels of Iron (umol/L) from start of study to end of study, between active and placebo groups
Time frame: Start of study to end of study (3 months)
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
Time frame: start of study to end of study (3 months)
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
Time frame: start of study to end of study (3 months)
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.
Dr Anthony Hobson
Other
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
Acronym: Vitals+
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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