Healthy Body Vitamin Pack: A Randomised Controlled Trial assessing mood and behaviour in adults reporting feeling stressed in the workplace.

The effects of Healthy Body Pack supplementation, relative to placebo, on mood and behaviour in adults reporting feeling stressed in the workplace.

Status

Terminated

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000295741

Enrollment

Registered

2013-03-18

Start date

2013-10-11

Completion date

2014-05-01

Last updated

2020-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Given the range of observed (randomised controlled trials) and purported (anecdotal and epidemiological evidence) effects of both multivitamin and Omega-3 supplementation has upon mood and behaviour the general aim of the study is to investigate the combined effects of Omega-3 and multivitamin supplementation. The study will focus on the effects on mood, workplace stress and cardiovascular health in a workplace sample. More specifically, a three month supplementation with Healthy Body Vitamin Pack is expected to improve the experience of workplace stress, workplace variables, cardiovascular risk parameters and mood in conjunction with an improvement in biological measures such as antioxidant status and triglycerides.

Interventions

Participants are randomly allocated to receive one of two treatments to be consumed once daily with a meal for a period of 12 weeks: A. Healthy Body Vitamin Pack (containing 2 x 600mg fish oil softgels and 1 x Basic One Iron free multivitamin and mineral oral tablet) OR B. Placebo tablets (2 x softgels and 1 x oral tablet) matched for appearance and flavor. Please note: The daily dosage of 1 Basic One Iron free multivitamin and mineral oral tablet contains: Vitamin A (as natural beta carotene) 2,000IU Vitamin C (ascorbic acid) 150mg Vitamin D (cholecalciferol) 2,000IU Vitamin E (as d-alpha tocopherol succinate) 200IU Thiamine (Vitamin B1 as HCI) 1.5mg Riboflavin (Vitamin B2) 2mg Niacinamide (niacinamide/Vitamin B3) 20mg Vitamin B6 (pyridoxine hydrochloride) 10mg Folic Acid (Folate/Vitamin B9) 400mcg Vitamin B12 (Cyanocobalamin) 400mcg Pantothenic Acid (as calcium pantothenate) 10mg Magnesium (as magnesium oxide) 200mg Zinc (zinc oxide) 15mg Selenium (as selenium chelate) 100mcg Chromium (as chromium amino acid chelate) 100mcg Lycopene 5mg

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

30 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

Participants who meet the following eligibility criteria will be recruited in the trial: 1. Healthy non-smoking males and females aged between 30 and 55 years. 2. Currently in full-time employment. 3. Are not heavy drinkers of alcohol (defined as greater than 14 standard drinks per week for women and 28 standard drinks per week for men). 4. No history of anxiety, depression, psychiatric disorders or epilepsy 5. No history of / do not currently suffer from heart disease or high blood pressure or diabetes. 6. Not taking any medication, herbal extracts, vitamin supplements or illicit drugs which might reasonably be expected to interfere with cognition or mood for 4 weeks prior to (and duration of) study (such as multivitamins, B vitamins, ginkgo biloba, antioxidants or other supplements). 7. Not taking any form of medication within 5 days of admission (except for prophylactic antibiotics, or other routine medications to treat benign conditions, such as antibiotics to treat acne) and agree not to take any medication throughout the study 8. No health conditions that would affect food metabolism including the following: food allergies, kidney disease, liver disease and/or gastrointestinal diseases (e.g. Irritable bowel syndrome, coeliac disease, peptic ulcers) 9. Not pregnant or breast feeding 10. Not allergic to gluten/wheat 11. Are willing and able to participate in all study requirements, treatment plan, have access to completeonline measures, and other trial procedures according to the protocol. 12. Are willing to provide blood samples on the two prescribed visits in the testing phase. 13. Provide a personally signed and dated informed consent indicating that the participant has been informed of all pertinent aspects of the trial. 14. Fluent in written and spoken English

Exclusion criteria

Participants presenting with any of the following will not be included in the trial: 1. Cigarette smoker 2. Current heavy regular use of alcohol exceeding 14 standard drinks per week for women and 28 standard drinks per week for men). 3. Diagnosis of Type 1 or Type 2 diabetes. 4. History of anxiety, depression, psychiatric disorders or epilepsy 5. History of / currently suffers from heart disease or high blood pressure. 6. Evidence or history of any clinically significant (in the judgment of the investigator) renal, endocrine, pulmonary, gastrointestinal, cardiovascular, psychiatric, neurological, within the last 5 years 7. Use of any over-the-counter herbal extracts, vitamin supplements and/or other dietary supplements which might influence cognition or mood for four weeks prior to the practice day (such as multivitamins, B vitamins, ginkgo biloba, antioxidants or other supplements). 8. Currently taking any illicit drugs and/or a history of substance abuse. 9. Health conditions that would affect food metabolism including the following: food allergies, kidney disease, liver disease and/or gastrointestinal diseases (e.g. have Irritable bowel syndrome, coeliac disease, peptic ulcers) 10. Pregnant or breast feeding 11. Not fluent in written or spoken English 12. Allergy to gluten/wheat 13. Are not willing to provide blood samples throughout the testing phases 14. Current participation in any other trials involving investigational or marketed products within 30 days prior to the practice day. 15. History of head injury/stroke 16. Any clinically relevant abnormalities in a volunteer’s medical history, physical examination, or results of laboratory tests. 17. Currently taking Warfarin 18. Are unable to participate in the treatment plan and other trial procedures according to the protocol

Outcome results