None listed
Conditions
Brief summary
Previous research suggests that some vitamins and minerals might help people with a variety of psychological concerns such as stress, anxiety, poor attention and low mood. One of the challenges associated with this research is that the doses are relatively high and some people don’t like or have problems with swallowing capsules. This research plans to address these challenges. The product that will be used in this study represents a new delivery modality that has not been researched before. The Lightning Stiks are powdered candy straws that contain a micronutrient blend and are simple and easy to take and are available in multiple flavours, which means that no swallowing of pills is necessary. The powder is held in the mouth for 30 seconds to a minute and absorbed sublingually and then swallowed. The proposed study will be the first independent study to investigate the feasibility and effectiveness of Lightning Stiks as an intervention for stress and wellbeing. The research will also look at the relationship between nutrients, stress, and academic grades. In addition, it will consider the impact of nutrients on stress associated with a pandemic (COVID19). It is hypothesized that the Lightning Stiks will be found to be an acceptable and effective intervention to reduce stress in undergraduate UC students relative to a placebo. We also expect the intervention group to show lower stress after the intervention compared with a control group of individuals choosing treatment-as-usual (controls). The study will use a randomized, double-blind, placebo-controlled design, and will consist of three study periods: Study period 1: Participants will be screened for eligibility by filling out an online web survey supplying demographic information and various psychometric measures. Assuming they are eligible, they will meet with the investigator over zoom/skype and eligibility checked, questions about the research answered, consent obtained, and participants will complete a baseline assessment. Participants will be mailed sufficient Stiks - either as active or placebo formula – to cover consumption during the trial period. Study period 2: A 4-week trial period consuming either micronutrients or a placebo with various psychometric questionnaires being completed on-line every two weeks. Study period 3: A 4-week open label trial where all participants will receive the active intervention and will fill out the same measures as before. The study will be completed in two phases (semester 1 and semester 2). Students will be followed up 3 months post end of trial completion. There will also be a control group of students who were either not eligible for the trial or decided not to participate.
Interventions
Previous research suggests that some vitamins and minerals might help people with a variety of psychological concerns such as stress, anxiety, poor attention and low mood. One of the challenges associated with this research is that the doses are relatively high and some people don’t like or have problems with swallowing capsules. This research plans to address these challenges.
The product that will be used in this study represents a new delivery modality that has not been researched before. The
Previous research suggests that some vitamins and minerals might help people with a variety of psychological concerns such as stress, anxiety, poor attention and low mood. One of the challenges associated with this research is that the doses are relatively high and some people don’t like or have problems with swallowing capsules. This research plans to address these challenges. The product that will be used in this study represents a new delivery modality that has not been researched before. The Lightning Stiks are powdered candy straws that contain a micronutrient blend of vitamins, minerals, and amino acids (see below for the ingredient list for the active intervention and the matching placebo). They are simple and easy to take and are available in multiple flavours, which means that no swallowing of pills is necessary. Participants in the STAR trial will be taking Stiks that are berry flavoured. The powder is held in the mouth for 30 seconds to a minute and absorbed sublingually and then swallowed. Participants will be taking 1 Lightning Stik or placebo per day for four weeks during RCT. After four weeks, all participants will be taking the active intervention (1 Lightning Stik per day) for another four weeks during the open-label phase. At the end of the RCT questionnaire, we will be asking participants as to how many Stiks they have left in their sachets. They will then count them and report it back to us, which will give us an indication of their adherence to the intervention. Ingredient list (active intervention): Servings per Container: 30 Serving Size: 1 Stik (2.6 g) Amount per Serving: Vitamin A (retinyl palmitate) 0.03 mg Vitamin C (ascorbic acid) 10.00 mg Vitamin D (cholecalciferol) 0.60 mcg Vitamin E (d-alpha tocopheryl succinate) 4.00 mg Thiamin (thiamin mononitrate) 0.30 mg Riboflavin 0.23 mg Niacin (niacinamide) 1.50 mg Vitamin B6 (pyridoxine hydrochloride) 0.60 mg Folic Acid 0.02 mg Vitamin B12 (cyanocobalamin) 0.02 mg Biotin 0.02 mg Pantothenic Acid (d-calcium pantothenate) 0.35 mg Calcium (as chelate) 22.00 mg Iron (as chelate) 0.23 mg Phosphorus (as chelate) 14.00 mg Iodine (from Atlantic kelp) 3.40 mcg Magnesium (as chelate) 10.00 mg Zinc (as chelate) 0.80 mg Selenium (as chelate) 3.40 mcg Copper (as chelate) 0.12 mg Manganese (as chelate) 0.16 mg Chromium (as chelate) 0.01 mg Molybdenum (as chelate) 2.40 mcg Potassium (as chelate) 4.00 mg Proprietary Blend (27.72 mg): Choline Bitartrate, DL-Phenylalanine, Vanadium Chelate, Citrus Bioflavonoids, Inositol, L-Glutamine, L-Methionine, Boron Chelate, Grape Seed Extract, Ginkgo Biloba Leaf, Germanium Sesquioxide, Nickel Chelate Ingredient list placebo: Erythritol, Natural Flavors, Malic Acid
Sponsors
University of Canterbury, School of Psychology, Speech, and Hearing
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) Participants must be enrolled in an undergraduate degree at UC, 2) 16 years of age and older as long as they possess a level of understanding sufficient to complete the questionnaires and examinations required by the protocol and be considered reliable and compliant with the protocol (including the ingestion of 1 Lightning Stik/day), 3) Participants require English language competence sufficient to understand study materials and answer questionnaires, 4) Scores on the DASS-21 indicating at least mild levels of stress will be used as cut-offs for inclusion; specifically, participants will be eligible if they score 15 or above on the DASS-21 stress scale at screening (using adjusted scoring).
Exclusion criteria
1) Potential participants must not have been taking psychotropic medications (e.g. antidepressants) in the prior 4 weeks nor for the trial period. 2) Any serious medical condition that might require hospitalization, 3) Any participant known to be allergic to the ingredients of the Stiks or placebo, 4) Pregnancy or breastfeeding, 5) Any medication with primarily central nervous system activity, including mood stabilizers, 6) Participation in study period 1 (semester 1) in either the active intervention or placebo group will exclude participation in study period 2 (semester 2). Participants won’t be excluded if taking any hormonal contraceptives.
Outcome results
None listed