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What are micronutrients?

Micronutrients include the vitamins, minerals, and amino acids you get from your food as part of a balanced diet. Some micronutrients you may be familiar with are:

• Thiamin, Riboflavin, Niacin
• Folate, biotin, Pantothenic acid (all the Bs)
• Vitamins D, K, E and A
• Calcium, Iron, Phosphorous
• Iodine, Magnesium, Zinc
• Selenium, Copper, Manganese
• Chromium, Molybdenum, Potassium

Micronutrients are essential for all brain activity including the production of neurotransmitters. Evidence suggests that there is an important link between sufficient quantities of micronutrients and mental wellbeing.

Mindfulness is the act of being deliberately present, bringing your full attention to the current moment. By being mindful, we can notice our thoughts, feelings, environment and bodily sensations without making any judgements.�� Evidence for mindfulness in psychology suggests that there are links between higher levels of mindfulness and positive affect, adaptive emotion regulation, and life satisfaction, as well as lower levels of psychopathological symptoms and negative affect.

However, no blinded controlled study to date has looked at whether these interventions, either alone or separately, can positively impact on emotional dysregulation in young children.

What is the study?��

160 children aged between 6–10 years will be recruited and randomised to one of four groups:

1)������������ Micronutrients + Mindfulness

2)������������ Micronutrients + Active Monitoring

3)������������ Placebo + Mindfulness

4)������������ Placebo + Active Monitoring

Treatment for the micronutrient/placebo condition will involve ingesting 1 powdered sachet per day. The study product is called Truehope Ultimate Sticks and is a formula consisting of 36 vitamins, minerals, and amino acids. It is fruity-flavoured and dissolves on the tongue, being absorbed in the mouth and gums. It’s great for kids because it means that there is no need to swallow any pills or capsules.

The placebo is a flavour-matched powder that contains no active ingredients. By using a placebo, we can control for the ‘placebo effect’.

Treatment for the mindfulness condition involves the child watching a 20-minute video series online once per week and participating in the relevant activities. As part of this condition, a designated whānau member will watch a content-matched 30-minute video series once per week, to complement the child’s learning.

All participants, including those in the active monitoring condition, will complete questionnaires at study entry, and every two weeks throughout the study period.

At the beginning of the study and every four weeks after, participants will meet with one of the study coordinators via Zoom to check in and gather some more data.

After the initial trial phase, all participants will get to try the active micronutrient formula and the mindfulness programme in the open-label phase. The total study length is 16 weeks including the open-label phase, where we will continue to collect data every two weeks.

There is no cost to participating. All product and interventions will be provided free of charge during the trial and open-label phase.

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Can I participate?

Inclusion:

1.������������ Aged 6-10 years

2.������������ Be emotionally dysregulated such that it significantly impairs daily functioning

3.������������ Medication-free (psychiatric) for more than 4 weeks

4.������������ Able to ingest 1 powder sachet per day

5.������������ Have a parent/guardian able to attend 6 weekly mindfulness sessions online with the child (must be the same parent/guardian each week)

6.������������ Have access to the internet

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Exclusion:

1.������������ Serious medical or psychiatric conditions potentially requiring hospitalisation

2.������������ Known allergy to any Stick or placebo ingredients

3.������������ Abnormality of mineral metabolism (e.g., Wilson’s disease, hemochromatosis)

4.������������ Epilepsy

5.������������ Serious mental health or behavioural concerns for either the parent or child that may disrupt their ability to engage with the online programme or compromise therapeutic learning

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Contact

Email us at mm.trial.info@gmail.com for more information or follow this link for the eligibility and screening questionnaire:��