A double-blind study to evaluate the effectiveness of bioavailability enhancers to increase blood absorption of antioxidants and fat-soluble nutrients over a 48-hour period in otherwise healthy individuals.
RDC Global Pty Ltd
610 participants
Jul 1, 2019
Interventional
Conditions
Summary
A double-blind study to evaluate the effectiveness of bioavailability enhancers to increase blood absorption of antioxidants and fat-soluble nutrients over a 48-hour period in otherwise healthy individuals.
Eligibility
Inclusion Criteria6
- Men and women aged over 18 years with normal dietary habits (no medically prescribed diet or slimming diet) including good representation of age and gender specifics.
- Clinically healthy, BMI 18.5-39.9
- No history or evidence of clinically significant medical conditions including, but not limited to, cardiovascular, neurological, psychiatric, renal, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or haematological abnormalities that are uncontrolled.
- Participant’s full agreement and ability to consent to participation in the study
- Participant’s ability to participate fully and comply with demands of the study including attendance at all scheduled blood collection time points.
- Female participants must be on a form of prescribed birth control (e.g. oral contraceptive pill)
Exclusion Criteria11
- Allergy to the investigational material
- Previous history of hematologic diseases (e.g. known susceptibility to thrombosis)
- Concomitant use of anticoagulant drugs (e.g. Warfarin Sodium) and any other prescribed medication (not for control of previously mentioned conditions above) expect for females on the oral contraceptive pill
- Female participants currently pregnant, lactating or undergoing fertility treatment
- Regular use of supplements containing the investigational material (e.g. omega-3 fatty acids), in the last 3 months, regular consumption of foods containing the investigational material (e.g. fish for omega-3, red meat and eggs for CoQ10)
- High alcohol consumption (equal to 21 standard drinks/week)
- Reported participation in another trial 1 month before the start of the study
- Recent history (within 12 months) of substance abuse including alcohol
- Development of serious, adverse events/reactions including but not limited to; fainting, life-threating dehydration and/or serious bruising from blood sampling, excessive and prolonged diarrhoea or gastrointestinal upset from fish oil consumption.
- Received treatment (radio &/or chemotherapy) for cancer (excluding BCC skin cancer) in past 2 years.
- Current smoker.
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Interventions
This study will evaluate the effectiveness of bioavailaibility enhancers to increase blood absorption of antioxidants and fat-soluble nutrients over a 48-hour period in otherwise healthy individuals. A maximum of 610 male and female participants aged over 18 will be recruited locally from databases, fliers and public media outlets for a parallel study design. Following preliminary screening via telephone, potential participants will attend an information session and will be requested to provide their consent for inclusion in the trial. Consenting potential participants will undergo a health assessment including lifestyle, current medications, physical assessment (e.g. height, weight) and medical history; this data will be used for comprehensive screening and to provide contextual data for the study. This trial comprises three investigational products (Resveratrol, Omega-3 and Ginkgo biloba) all in capsule form. Within each product, there may be more than 1 form to be tested. Resveratrol comprises 3 doses, each with an A and B group. Omega-3 comprises 3 products; fish oil with 3 doses, each with an A and B group, Krill oil with 1 dose with an A and B group and Algae oil with 7 doses, each with an A and B group. A total of 610 participants will be recruited to allow for withdrawals and maintain power. 1). Resveratrol 1. Standard (n=60 total) a. 75 mg with AquaCelle b. 75 mg without AquaCelle 2. Standard (n=60 total) a. 100 mg Standard with AquaCelle b. 100 mg Standard 3. Veri-te™ (n=60 total) a. 150 mg Veri-te with AquaCelle b. 150 mg Veri-te standard 2). Omega-3 oil 1. Fish oil (n=180 total) a. 300 mg with AquaCelle b. 300 mg Standard c. 500 mg with AquaCelle d. 500 mg Standard e. 1,000 mg with AquaCelle f. 1,000 mg Standard 2. Krill oil (n=60 total) a. 150 mg with AquaCelle b. 150 mg Standard 3. Algae oil dose response trial (n=70 total) a. 300 mg (n=5) b. 300 mg with AquaCelle (n=5) c. 600 mg (n=5) d. 600 mg with AquaCelle (n=5) e. 900 mg (n=5) f. 900 mg with AquaCelle (n=5) g. 1200 mg (n=5) h. 1200 mg with AquaCelle (n=5) i. 1800 mg (n=5) j. 1200 mg with AquaCelle (n=5) k. 2100 mg (n=5) l. 2100 mg with AquaCelle (n=5) m. 2700 mg (n=5) n. 2700 mg with AquaCelle (n=5) 3). Ginkgo biloba 1. Standard Ginkgo (n=60 total) a. 160 mg b. 120 mg (Blackmores tablet) 2. Liposomal Ginkgo (n=60 total) a. Ginkgosome™ – 120 mg Ginkgo biloba extract b. Virtiva – 120mg Ginkgo biloba extract Veri-te™ is a commercial resveratrol product produced by Evolva SA. Once enrolled in the trial, participants will be allocated one of the groups (e.g. A or B). Participants will be blinded to the make-up of the treatment. Prior to attending the clinic for the trial, participants will be mailed a urine collection kit to provide approximately 20 mL of mid-steam urine for testing of the supplement metabolites. This sample is to be collected on the morning of the clinic visit and returned to the clinic on the same day of testing. For 48 hours prior to the initial baseline blood draw participants will be provided with a list of foods to exclude from their diet. On the day prior to the baseline blood draw participants will be instructed to not eat or drink anything other than water after 10pm. On day one of the study a fasting blood sample will be taken upon each participant’s arrival at the clinic beginning at approximately 7:30am. Participants will then be provided the allocated treatment dose to take with a cup (240 mL) of plain water. Within 30 minutes of taking the product, a standardised breakfast meal will be served to each participant. A second urine sample will be provided on the morning of the 24-hour testing. A maximum of 10 blood samples will then be taken over a period of up to 48 hours. The exact timing of the blood draws are detailed in the table below. All meals and snacks for the first day will be provided. Supplement Timing of blood draws post ingestion Resveratrol 0, 0.5, 1, 2, 3, 4, 5, 6, 8 and 24 hours Omega-3 (fish, krill & algae oils) 0, 2, 4, 6, 8, 10, 12, 24 and 48 hours Ginkgo biloba 0, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours The meals and food provided during the trial will be identical for each participant. The participants will be provided a list of foods to avoid for the duration of the study (specific to each supplement). This will conform to Australian dietary guidelines for adults. However, foods known to be high in the investigational product will be excluded.
Locations(1)
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ACTRN12619000953134