None listed
Conditions
Brief summary
The purpose of this research study is to see if omega-3 fats (the healthy fats) can improve on various health conditions, including depression, anxiety, stress, impulsive behaviour, as well as risk factors for heart disease, which will be measured in a blood sample. Study participants that have volunteered for this study will be provided with the omega-3 supplements which they will take daily for up to 16 weeks. They will attend 2 clinic visits before and after omega-3 supplementation, provide blood samples and answer various questionnaires at both clinic visits, so we (the researchers) can see what potential improvements have been made to the various health conditions.
Interventions
This trial is a proof of concept, open label, pilot feasibility clinical trial assessing the effect of Omega-3 supplementation on behaviour and mental health (including impulsivity, anxiety, depression and stress) and cardiovascular health (risk biomarkers), with the validation of the updated PUFA FFQ embedded in the baseline measures being collected.
Study participants are healthy adults who are consuming various habitual diets (vegan, vegetarian or non-restricted diets) and a convenience sampl
This trial is a proof of concept, open label, pilot feasibility clinical trial assessing the effect of Omega-3 supplementation on behaviour and mental health (including impulsivity, anxiety, depression and stress) and cardiovascular health (risk biomarkers), with the validation of the updated PUFA FFQ embedded in the baseline measures being collected. Study participants are healthy adults who are consuming various habitual diets (vegan, vegetarian or non-restricted diets) and a convenience sample will be recruited from the University of Wollongong and via social media. The two clinic visits will be conducted at the Clinical Trial Research Unit at the University of Wollongong. Baseline measures include providing a fasted blood sample, blood pressure, height, weight, waist circumference, completing questionnaires (demographic, dietary (Polyunsaturated Fatty Acid Food Frequency Questionnaire (PUFA FFQ) and Intake24), physical activity, behavioural, and mental health). Total clinic visit time is 90 minutes (clinic measures approx 45 minutes and questionnaires approx 45 minutes). Specifically, for the Validation sub-study, all clinical measures (including blood omegas-3 levels) are required and the dietary measures (Polyunsaturated Fatty Acid Food Frequency Questionnaire (PUFA FFQ) and Intake24). Intervention is 1g algal omega-3 supplementation per day (oral powder dissolved in half cup of water) for up to 4 months. Study participants will monitor their own omega-3 blood levels via Omega-Quant fingerprick assessment and once study participants reach a target level of omega-3 index of 8%, they will attend the post-intervention clinic visit and cease taking omega-3 supplements. Therefore the post-intervention clinic visit may be 4 weeks, 8 weeks, 12 weeks or 16 weeks after the baseline clinic visit. Post-intervention clinic visit measures will be the same as baseline clinic visit, except for height and demographic questionnaire. Total clinic visit time 90 minutes. Any unused algal omega-3 sachets and Omega-Quant fingerprick kits will be returned. Adherence to study protocol will be assessed by the omega-3 index assessment at baseline and post-intervention.
Sponsors
The University of Wollongong
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
age 18 years or older, can speak English, maintained a constant diet over the last 3 months - which is assessed by one of the questions in the polyunsaturated fatty acid food frequency questionnaire
Exclusion criteria
Pregnant women
Outcome results
None listed