HealthyAMPNCT03869086
Metabolism of Anthocyanins and Heart Health
A study testing Freeze dried blueberry powder in people with Healthy, run by University of East Anglia at 1 site in United Kingdom.
Trial summary
This study aims to find out if consuming a single dose of blueberries, rich in anthocyanins, within an energy dense meal, improves blood vessel function and biomarkers of heart health. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Freeze dried blueberry powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Jun 2019to 6 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI >= 25 kg/m2
- Adults aged 50 - 80 years old
- Successful biochemical, haematological, and urinalysis assessment at screening
Who cannot join
- Current smokers, or ex-smokers ceasing < 6 months ago
- existing or significant past medical history of vascular disease or medical conditions likely to affect the study measures
- Fructose or lactose intolerant subjects or known allergies to intervention treatments
- Those unprepared to adhere to dietary instructions
- Parallel participation in another research project involving dietary intervention and/or sampling of biological fluids/material
- Those on therapeutic diets or having experienced substantial weight loss within 2 months of screening.
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- Those taking flavonoid, nitrate / nitrite containing or fish oil containing supplements (and unwilling to cease intake during, and 1 month preceding the trial) or unwilling to maintain existing intake of other supplements.
- Prescribed hypoglycaemic, anti-hypertensive, vasodilator or hormone replacement therapy (HRT) medication.
- Unsatisfactory biochemical, haematological or urinary results or measurements considered to be counter indicative for the study
- Undiagnosed hypertension (elicited at screening; i.e. ≥ 180 / 110mmHg) at a level requiring immediate referral back to general practitioner for follow-up
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Quadram Institute Clinical Research Facility; a partnership facility of the NHS, UEA and QIB
Norwich, Norfolk, NR4 7UQ
About this study
Official title: The Effects of Blueberry Anthocyanin Metabolism on Acute Cardiometabolic Health
This study aims to find out if consuming a single dose of blueberries, rich in anthocyanins, within an energy dense meal, improves blood vessel function and biomarkers of heart health. The study specifically aims to confirm if differences in how individuals process the bioactive compounds in blueberries, called anthocyanins, has an influence on heart health. The investigators will assess the effects of eating one portion of blueberries on vascular health over a 48hour period, and will track the breakdown compounds within blood and urine, to see if health effects are related to metabolism.
Read the detailed description
The primary aim of this cross-over designed, placebo controlled, acute dietary intervention study, is to prospectively recruit participants on the basis of anthocyanin metabolism profiles (based on profiles confirmed in our previous studies) following a 'blueberry challenge'. Acute cardio and metabolic function responses will be assessed (by metaboliser profile), following an energy dense test meal with/without the addition of blueberries.
Participants will be healthy, but overweight and obese (BMI inclusion: ≥ 25kg/m2) men and women (aged 50 y to 80 y), who will initially undertake a 'blueberry challenge' by consuming a single dose of freeze dried blueberries. Anthocyanin metaboliser type will be profiled from the analysis of metabolites within urine, collected for 48h following the 'challenge'.
A total of 70 participants will complete the intervention (n=35 FAST and n=35 SLOW metabolisers) which consists of two, test meal periods (separated by at least 7d and allocated in random order); 1) energy dense test meal plus freeze dried blueberries, 2) energy dense test meal plus an isocaloric matched placebo material. Urine samples and ambulatory blood pressure measures will be collected for 24h prior to, and then over the 48h period which follows the test meal intake. Further assessment of vascular and metabolic function will be made at pre-defined times over the 48h postprandial period. Dietary restrictions to abstain from blueberries and reduce the anthocyanin intake level, will be applied for 5d before each test meal intake. In addition, all food and drink will be provided for a 4d period (2d before and during the 48h following the energy dense test meal) to further control the intake of flavonoids and to standardise the influence of background diet on metabolism profile.
- Conditions
- Healthy
- Being tested
- Freeze dried blueberry powder, Anthocyanin free, sugar-matched placebo
- Keywords
- Blueberry, Metabolism, Anthocyanins, Inter-individual variation, Cardiometabolic health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freeze dried blueberry powderOther
36 g of freeze-dried blueberry powder to be mixed with milk and served together with an energy-dense meal.
Anthocyanin free, sugar-matched placeboOther
36 g of isocaloric placebo, matched for sugars to be mixed with milk and served together with an energy-dense meal.
| Study group | Role | What they receive |
|---|---|---|
| SLOW anthocyanin metabolisers | Experimental | Participants will be prospectively recruited to the SLOW anthocyanin metaboliser group, following a pre-intervention screen (blueberry challenge). Participants in this arm will consume (in random order) blueberry and placebo interventions (both consumed with an energy dense meal) in a cross-over manner. At least 7 days washout will be observed between the two treatments. Receives: Other: Freeze dried blueberry powder; Other: Anthocyanin free, sugar-matched placebo |
| FAST anthocyanin metabolisers | Experimental | Participants will be prospectively recruited to the FAST anthocyanin metaboliser group, following a pre-intervention screen (blueberry challenge). Participants in this arm will consume (in random order) blueberry and placebo interventions (both consumed with an energy dense meal) in a cross-over manner. At least 7 days washout will be observed between the two treatments. Receives: Other: Freeze dried blueberry powder; Other: Anthocyanin free, sugar-matched placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brachial artery endothelial function
percentage maximum dilatation assessed via flow mediated dilation (%FMD): (diametermax-diameterbaseline) / diameterbaseline×100.
Measured: assessed at 0, 1.5, 3, 6, 24, 48 hours after intervention intake
Secondary outcomes (4)
Office blood pressure
Measurements of blood pressure
Measured: Assessed at 0, 3, 6, 24, 48 hours after intervention intake.
Bioavailability - serum
Assessment of flavonoid and metabolite levels in blood samples
Measured: Measured prior to, and then at +20, +40, +60, +90, +120, +180, +270 and +360 minutes, +24 hours and +48 hours following the energy dense meal intake.
Postprandial Insulin response
Assessment of postprandial insulin control
Measured: Measured prior to, and then at +20, +40, +60, +90, +120, +180, +270 and +360 minutes, +24 hours and +48 hours following the energy dense meal intake.
Total cholesterol
Assessment of blood cholesterol
Measured: Measured prior to, and then at +20, +40, +60, +90, +120, +180, +270 and +360 minutes, +24 hours and +48 hours following the energy dense meal intake.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start4 Jun 2019
- Primary completion6 Jan 2021
- Study completion6 Jan 2021
Why it stopped: COVID-19 related inability to complete study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Our research design involves screening individuals and then prospectively recruiting on the basis of two distinct blueberry metabolism profiles based on our previous research findings (in a population with metabolic syndrome). Our study will assess whether individuals with SLOW and FAST anthocyanin metabolism profiles respond differently and will test if the difference in processing may influence cardio metabolic responses. Our study involves feeding a single energy-dense meal which we anticipate will have a transient deleterious effect on acute markers of health. We will test whether adding blueberries to the energy dense meal improves acute responses compared against when adding the equivalent isocaloric amount of placebo. Participants will experience the blueberry and placebo treatments in random order
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of East Anglia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aedin Cassidy, PhD, Principal investigator, University of East Anglia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03869086
- Sponsor's protocol ID
- AMP001_22NOV2018
- Acronym
- AMP
- Status last verified
- Jan 2021
- First submitted
- 4 Mar 2019
- Last updated
- 2 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Blueberry Anthocyanin Metabolism on Acute Cardiometabolic Health
- ClinicalTrials.gov ID
- NCT03869086
- Acronym / sponsor ID
- AMP / AMP001_22NOV2018
- Conditions
- Healthy
- Keywords
- Blueberry, Metabolism, Anthocyanins, Inter-individual variation, Cardiometabolic health
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 related inability to complete study
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of East AngliaUniversity, hospital or other
- Study start
- 4 Jun 2019 (actual)
- Primary completion
- 6 Jan 2021 (actual)
- Study completion
- 6 Jan 2021 (actual)
- First posted
- 11 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to find out if consuming a single dose of blueberries, rich in anthocyanins, within an energy dense meal, improves blood vessel function and biomarkers of heart health. The study specifically aims to confirm if differences in how individuals process the bioactive compounds in blueberries, called anthocyanins, has an influence on heart health. The investigators will assess the effects of eating one portion of blueberries on vascular health over a 48hour period, and will track the breakdown compounds within blood and urine, to see if health effects are related to metabolism.
Detailed description
The primary aim of this cross-over designed, placebo controlled, acute dietary intervention study, is to prospectively recruit participants on the basis of anthocyanin metabolism profiles (based on profiles confirmed in our previous studies) following a 'blueberry challenge'. Acute cardio and metabolic function responses will be assessed (by metaboliser profile), following an energy dense test meal with/without the addition of blueberries.
Participants will be healthy, but overweight and obese (BMI inclusion: ≥ 25kg/m2) men and women (aged 50 y to 80 y), who will initially undertake a 'blueberry challenge' by consuming a single dose of freeze dried blueberries. Anthocyanin metaboliser type will be profiled from the analysis of metabolites within urine, collected for 48h following the 'challenge'.
A total of 70 participants will complete the intervention (n=35 FAST and n=35 SLOW metabolisers) which consists of two, test meal periods (separated by at least 7d and allocated in random order); 1) energy dense test meal plus freeze dried blueberries, 2) energy dense test meal plus an isocaloric matched placebo material. Urine samples and ambulatory blood pressure measures will be collected for 24h prior to, and then over the 48h period which follows the test meal intake. Further assessment of vascular and metabolic function will be made at pre-defined times over the 48h postprandial period. Dietary restrictions to abstain from blueberries and reduce the anthocyanin intake level, will be applied for 5d before each test meal intake. In addition, all food and drink will be provided for a 4d period (2d before and during the 48h following the energy dense test meal) to further control the intake of flavonoids and to standardise the influence of background diet on metabolism profile.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Our research design involves screening individuals and then prospectively recruiting on the basis of two distinct blueberry metabolism profiles based on our previous research findings (in a population with metabolic syndrome). Our study will assess whether individuals with SLOW and FAST anthocyanin metabolism profiles respond differently and will test if the difference in processing may influence cardio metabolic responses. Our study involves feeding a single energy-dense meal which we anticipate will have a transient deleterious effect on acute markers of health. We will test whether adding blueberries to the energy dense meal improves acute responses compared against when adding the equivalent isocaloric amount of placebo. Participants will experience the blueberry and placebo treatments in random order
| Arm | Type | Receives |
|---|---|---|
| SLOW anthocyanin metabolisers | Experimental | Other: Freeze dried blueberry powder, Other: Anthocyanin free, sugar-matched placeboParticipants will be prospectively recruited to the SLOW anthocyanin metaboliser group, following a pre-intervention screen (blueberry challenge). Participants in this arm will consume (in random order) blueberry and placebo interventions (both consumed with an energy dense meal) in a cross-over manner. At least 7 days washout will be observed between the two treatments. |
| FAST anthocyanin metabolisers | Experimental | Other: Freeze dried blueberry powder, Other: Anthocyanin free, sugar-matched placeboParticipants will be prospectively recruited to the FAST anthocyanin metaboliser group, following a pre-intervention screen (blueberry challenge). Participants in this arm will consume (in random order) blueberry and placebo interventions (both consumed with an energy dense meal) in a cross-over manner. At least 7 days washout will be observed between the two treatments. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI >= 25 kg/m2
- Adults aged 50 - 80 years old
- Successful biochemical, haematological, and urinalysis assessment at screening
Key exclusion criteria (10 listed)
- Current smokers, or ex-smokers ceasing < 6 months ago
- existing or significant past medical history of vascular disease or medical conditions likely to affect the study measures
- Fructose or lactose intolerant subjects or known allergies to intervention treatments
- Those unprepared to adhere to dietary instructions
- Parallel participation in another research project involving dietary intervention and/or sampling of biological fluids/material
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Freeze dried blueberry powder36 g of freeze-dried blueberry powder to be mixed with milk and served together with an energy-dense meal. | Other | FAST anthocyanin metabolisers, SLOW anthocyanin metabolisers |
| Anthocyanin free, sugar-matched placebo36 g of isocaloric placebo, matched for sugars to be mixed with milk and served together with an energy-dense meal. | Other | FAST anthocyanin metabolisers, SLOW anthocyanin metabolisers |
Primary outcome
Brachial artery endothelial function
Time frame: assessed at 0, 1.5, 3, 6, 24, 48 hours after intervention intake
percentage maximum dilatation assessed via flow mediated dilation (%FMD): (diametermax-diameterbaseline) / diameterbaseline×100.
4 secondary outcomes
Office blood pressure
Time frame: Assessed at 0, 3, 6, 24, 48 hours after intervention intake.
Bioavailability - serum
Time frame: Measured prior to, and then at +20, +40, +60, +90, +120, +180, +270 and +360 minutes, +24 hours and +48 hours following the energy dense meal intake.
Postprandial Insulin response
Time frame: Measured prior to, and then at +20, +40, +60, +90, +120, +180, +270 and +360 minutes, +24 hours and +48 hours following the energy dense meal intake.
Total cholesterol
Time frame: Measured prior to, and then at +20, +40, +60, +90, +120, +180, +270 and +360 minutes, +24 hours and +48 hours following the energy dense meal intake.
Results and safety
The study was stopped early (reason given: COVID-19 related inability to complete study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aedin Cassidy, PhD principal investigator
University of East Anglia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Freeze dried blueberry powder in people with Healthy, run by University of East Anglia at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID-19 related inability to complete study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brachial artery endothelial function (time frame: assessed at 0, 1.5, 3, 6, 24, 48 hours after intervention intake). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021.