RecruitingPhase 4ACTRN12619000953134

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.


Sponsor

RDC Global Pty Ltd

Enrollment

610 participants

Start Date

Jul 1, 2019

Study Type

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

Sex: Both males and femalesMin Age: 19 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether special ingredients called bioavailability enhancers can help your body absorb antioxidants and fat-soluble nutrients more effectively from supplements. When you take vitamins or supplements like omega-3 fatty acids or CoQ10, your body doesn't always absorb everything — this study looks at whether adding certain compounds can improve that absorption over a 48-hour window. Participants will take a supplement and have blood samples drawn at several time points over two days. The study is double-blind, meaning neither you nor the researchers will know which version of the supplement you receive until the study ends. This helps ensure the results are fair and unbiased. You may be eligible if you are a healthy adult over 18 with a normal BMI, no significant medical conditions, and no recent use of supplements containing the ingredients being tested (such as omega-3 or CoQ10). Women must be on prescribed birth control. Current smokers, pregnant women, or people on blood-thinning medications are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.

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)

QLD, Australia

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ACTRN12619000953134