None listed
Conditions
Brief summary
Scientific evidence shows that ginsenosides (saponin compounds) naturally present in ginseng species (Korean ginseng Panax ginseng and other Panax species) can confer multiple health benefits, including support for optimal sugar regulation and cognitive performance. However this research has been done on the ginseng root, and whilst ginseng berries (red or yellow) show a variety of potentially bioactive ginsenosides, similar to those found in the root, it is unclear whether ginseng berries possess any health properties. In this preliminary feeding study, we hypothesis that consumption of a single dose of a supplement containing a ginseng red berry extract will upon gut digestion / metabolism generate bioactive ginsenosides (similar to those found in root and/or novel bioactive compounds) that exhibit health properties that supports sugar regulation and cognitive wellbeing.
Interventions
This trial is aimed at assessing how ginseng red berry supplementation (24 hr post-consumption) influences glucose metabolism and cognitive function. The trial is a double-blinded parallel design. This design was selected since this is a preliminary study and the time-dependent bioactivity of ginseng red berry metabolites within the body is currently unknown; a parallel trial design will eliminate any potential problems from a cross-over design.
Participants will be randomised into 2 groups; gr
This trial is aimed at assessing how ginseng red berry supplementation (24 hr post-consumption) influences glucose metabolism and cognitive function. The trial is a double-blinded parallel design. This design was selected since this is a preliminary study and the time-dependent bioactivity of ginseng red berry metabolites within the body is currently unknown; a parallel trial design will eliminate any potential problems from a cross-over design. Participants will be randomised into 2 groups; group 1 will consume a single dose of ginseng red berry supplement containing 750 mg ginseng red berry extract, whereas group 2 will consume a matched placebo containing a cellulose food filler equivalent to the amount of ginseng red berry extract. These supplements are prepared commercially by Natural F&P Corporation (South Korea) and meet both Korea and New Zealand food safety requirements for human consumption and administered to the participants in the form of 3 tablets (each containing 250 mg ginseng red berry extract) with water. The trial will take place in designated clinical facilitates within PFR and will be conducted by experience trial co-ordinators, who are also First Aider and trained phlebotomist. This trial will consist of 3 sessions, each of which will be carried out over 3 days; session 1 (familiarisation session) and session 1 and 2 (main trial sessions. Briefly, in session 1, participants will be asked to consuming a sugar drink (containing 60 g sucrose) and at specific times over the next 2 hrs blood sugar metabolites will be measured. In session 2, participants will initially be asked to complete a mood questionnaire (POMS), followed by consuming a sugar drink (containing 60 g sucrose). At specific times over the next 2 hrs blood sugar metabolites will be measured. In addition, after 15mins, the participants will be asked to complete a series of computerised mental tasks (takes about 7 mins). After the 2hrs, participants will then be asked to consume a ginseng or placebo supplement and asked to return 24 hrs later to complete session 3. In session 3, participants are asked to repeat the assessments of session 2 without the consumption of ginseng.
Sponsors
Jocelyn Eason
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
16 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy individuals (male or female) 16-65 yrs. Participants will be required to complete a health questionnaire and provide informed written consent for this study.
Exclusion criteria
Participants will be excluded if they are unwilling or unable to provide informed written consent or comply with study procedures. Participants will also be excluded if they have (i) known hypersensitivity or intolerance to ginseng (root or berry) products, (ii) health conditions that may their ability to regulate sugar digestion/absorption (i.e. diabetes, metabolic syndrome), (iii) suffer from regular headaches / migraines or trouble sleeping (insomnia) or (iv) have a health conditions that may affect ability to do computerised cognitive tasks (e.g., eye sight problems, colour blindness, aura migraines, epilepsy). In addition, participants will be excluded if they are (a) pregnant or planning to get pregnant in the near future or have any of the following conditions: (b) blood borne diseases (e.g., hepatitis), (c) clinically diagnosed high/low blood pressure or heart disease, (d) regular gastrointestinal disturbances, i.e. dyspepsia, diarrhoea, (e) recent bacterial or viral illness, (f) autoimmune disorders such as rheumatoid arthritis, multiple sclerosis, (g) are taking any mediation that affects the properties of blood (e.g. blood clotting) or kidney function. In addition, potential volunteers will be excluded if they have donated blood within 4 weeks from the start of the study.
Outcome results
None listed