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The bioequivalence of two commerical blackcurrant extracts and the effect of caffeine on the appearance of blackcurrant polyphenolics in blood plasma in healthy participants.

Investigating the polyphenol bioequivalence of a spray-dried blackcurrant powder with a commercial blackcurrant extract and determining the acute effect of caffeine on the polyphenol bioavailability when co-consumed with blackcurrant powder in healthy participants.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620001248954
Enrollment
9
Registered
2020-11-20
Start date
2020-11-30
Completion date
2020-12-11
Last updated
2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

There is growing evidence for the efficacy of supplementation with anthocyanin-rich foods in supporting exercise performance and cognition. In these studies, the dose and timing of supplementation were critical considerations to ensure the delivery and appropriate dose of anthocyanins to confer their functional benefits. New Zealand blackcurrants are rich in anthocyanins and have a unique profile from other berryfruit. In previous bioavailability studies, we reported that the anthocyanins are temporally bioavailable for several hours after blackcurrant extract consumption where it peaks at 2 hours post-consumption. Depending on the processing procedure of blackcurrants extract, the final food product may vary in properties (i.e. water solubility) and may contain other constituents such as maltodextrin in spray-dried extracts. These considerations are important as the food matrix may influence the rate and extent at which anthocyanins are absorbed by the body, even though the same dose of anthocyanin is consumed. Caffeine is one of numerous scientifically supported supplements known to have an ergogenic effect on physical and cognitive performance through their ability to stimulate the central nervous system and regulate mitochondrial function. Given the evidence for the effect of blackcurrants in regulating these mechanisms, it is possible that caffeine can synergistically improve physical and cognitive performance when co-ingested with blackcurrants compared with blackcurrants alone. Whether co-ingestion of caffeine interferes with blackcurrant anthocyanin delivery, however, is unclear and will need to be established to reveal whether caffeine and blackcurrant anthocyanins are synergistic in supporting physical and cognitive performance. In this study, we seek to investigate the bioequivalence of anthocyanins in human plasma following the consumption of a single dose of a spray-dried blackcurrant powder compared to anthocyanin-enriched blackcurrant extract. Furthermore, we also aim to investigate the effect of co-consuming caffeine with blackcurrant powder on the bioavailability of anthocyanins in human blood plasma.

Interventions

This is a double-blind, three-arm repeated measures crossover study that will allow us to evaluate the bioequivalence of anthocyanins in human plasma following the consumption of two commercial blackcurrant extracts. Additionally, we seek to determine the effect of co-consuming caffeine with blackcurrant powder on the bioavailability of anthocyanins in human blood plasma. Prospective participants who have passed the study’s inclusion/exclusion criteria will be asked to attend a familiarisation

This is a double-blind, three-arm repeated measures crossover study that will allow us to evaluate the bioequivalence of anthocyanins in human plasma following the consumption of two commercial blackcurrant extracts. Additionally, we seek to determine the effect of co-consuming caffeine with blackcurrant powder on the bioavailability of anthocyanins in human blood plasma. Prospective participants who have passed the study’s inclusion/exclusion criteria will be asked to attend a familiarisation session where they will meet with the study’s principal investigator. During this session, the study’s principal investigator (research scientist, PhD) will explain the purpose of the study and what is expected from them as a participant. They give potential participants a copy of the information sheet and health questionnaire for them to take home and complete. Recruited participants will be required to complete all three treatment interventions of this study: (1) spray-dried blackcurrant powder, (2) spray-dried blackcurrant powder + caffeine and (3) anthocyanin-enriched blackcurrant extract. The order at which participants will consume the treatments will be randomised. Participants will be instructed to refrain from consuming a list of food, drinks and dietary supplements containing anthocyanins 24 hours before their trial day. On each trail day, participants will be given a standardised breakfast bar to consume with water to have for breakfast 2 hours before the beginning of the trial. On the first trial day, participants will be given their allocated blackcurrant treatment to consume with 250 mL of water as quickly as possible. All blackcurrant treatments will contain a dose of anthocyanins relative to each participant’s bodyweight (3.2 mg total anthocyanins/kg bodyweight). The blackcurrant + caffeine intervention will contain a caffeine dose of 3 mg/kg bodyweight. Venous blood (approximately 5 mL) samples will be collected from participants 0, 1, 2, 4 and 6 hours after consuming their treatment. The trial coordinator (research associate) of this study will be instructing all participants of what is required of them on their trial day. To monitor participants’ adherence to the dietary restrictions, each participant will be asked to recall if they have consumed any foods containing anthocyanins from a list provided within the last 24 hours prior to starting their trial day. A baseline blood sample will also be collected on each trial day before participants are given their intervention. This will be analysed for anthocyanin and other polyphenolics and will indicate participants’ adherence to the dietary restrictions. Participants will be required to return to complete the two other trial days where they will be given the intervention that they did not receive on previous trial days. Overall the study duration for each participant is three weeks. Each trial day will last approximately 6.5 hours and each trial day will be separated by at least five days.

Sponsors

Dr. Dominic Lomiwes
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

Healthy individuals (male or female) 18 – 55 years who are able to provide written consent to participate in this study will be selected from this study.

Exclusion criteria

Participants will be excluded if they are unwilling or unable to provide written consent or comply with the study procedures. Participants will also be excluded if they have known hypersensitivity or intolerance to caffeine, blackcurrants or berryfruit-derived products. In addition, participants will be excluded if they are pregnant, planning to get pregnant in the immediate future or have any of the following conditions: (i) blood borne diseases (e.g. hepatitis), (ii) clinically diagnosed high/low blood pressure, (iii) recent bacterial or viral illness or (iv) are taking medication that affects the properties of blood (e.g. blood clotting).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026