None listed
Conditions
Brief summary
Aim: A study investigating the bio-efficiency of de-alcoholised red and white wine as an antioxidant in humans using both red and white wine formulas. The study will be split into two 3 week blocks. Each participant will be involved for only 3 consecutive weeks. Recruitment: 8 healthy females are required. Study design: Participants will fast for 10 hours overnight (water allowed) prior to each study day. During the 24 hours prior to each visit, participants will be asked to refrain from consuming foods/drinks that are rich in polyphenolic compounds (a list will be provided to them). In the first week, participants will be randomised to one of 3 treatments. In the second week, participants will be randomised to one of the remaining 2 treatments and in the third week, participants will cross over to the last treatment. Drinks will be blinded to minimise any impact on the outcomes of the research.
Interventions
Participants will be randomised to 1 of 3 treatments. 1 acute day (once per week for 3 weeks) of 600ml of red or white de-alcoholised wine given as a drink (to be entirely consumed within 10 minutes of the baseline blood sample being collected) compared with 600ml water as the control (to be completely consumed within 10 minutes of the baseline blood sample being collected).
Each participant will be involved for 3 weeks. On day one of the first week, each participant will be randomised to one o
Participants will be randomised to 1 of 3 treatments. 1 acute day (once per week for 3 weeks) of 600ml of red or white de-alcoholised wine given as a drink (to be entirely consumed within 10 minutes of the baseline blood sample being collected) compared with 600ml water as the control (to be completely consumed within 10 minutes of the baseline blood sample being collected). Each participant will be involved for 3 weeks. On day one of the first week, each participant will be randomised to one of the study drinks or the control drink. At visit 2 (one week later) the participant will be randomised to either one of the remaining study drinks or control drink. At the third visit (one week after visit 2), participants will consume either the remaining study drink or control drink. Participants will refrain from foods and beverages containing polyphenolic compounds for 24 hours prior to each of their 3 weekly visits, and will fast (water allowed) for 10 hours prior to each visit. Week 1: Following the last blood sample being collected on the morning of each visit, the participants will resume their usual diet until 24 hours prior to each of their second and 3rd clinic visits. There will be two groups of 4 participants on this trial over a six week period. Each group of 4 participants will complete 3 consecutive weeks on the study. The 7 days between each visit is the washout period.
Sponsors
Australian Vintage Ltd
Study design
Allocation
Randomised controlled trial
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
25 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy females; aged 25 - 50 years; willing to refrain from consuming polyphenolic-rich food/beverages for 24 hours prior to each study day(e.g. red and/or white wine); females who drink red and white wine.
Exclusion criteria
Cigarette smoker currently or within the past six months; receiving medical treatment including anti-folate drugs currently or within the past six months e.g. aminopterin (AMT) and methotrexate (MTX); planning a pregnancy or currently pregnant; females allergic to compounds present in red and white wines.
Outcome results
None listed