Healthy DietNCT04329962
Metabolism and Absorption of Anthocyanins From Extract and Whole Blueberry Powder Confections in Healthy Adults
A study testing Blueberry Powder Food Product, Dietary Intervention and Questionnaire Administration in people with Healthy Diet and Nutrition Aspect of Cancer, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This trial studies how well a group of compounds found in blueberries called anthocyanins are absorbed into the body from 2 different types of blueberry confections (blueberry extract and whole blueberry powder). Blueberries contain several compounds which may be beneficial for human health and prevention of disease. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Diet, Nutrition Aspect of Cancer
- What is being tested?
- Blueberry Powder Food Product, Dietary Intervention and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2018to 31 May 2018
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be healthy, free-living adults
- Have a body mass index (BMI) between 18 and 35 kg/m^2
- Be a non-smoker (defined as adults who have never smoked or who have not had a cigarette in the past ten years)
- Agree to follow a berry-restricted diet and to document any accidental consumption of restricted foods each day of the study
Who cannot join
- Report being actively treated for any metabolic, digestive or immunologic disorder including malabsorptive disorders, renal insufficiency, hepatic insufficiency, any autoimmune disorder or short bowel syndrome
- Have a known allergy or food intolerance to ingredients in study products (blueberries), other berries, wheat, or soy
- Are strict vegans (no consumption of animal, fish or egg products)
- Are planning to conceive, or are currently pregnant or lactating
- Are heavy alcohol consumers (defined as an average consumption of greater than 2 drinks/ day)
- Have been on an antibiotic regime lasting for one week in the last 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: Comparison of Bioavailability and Urinary Metabolite Profile After Consumption of Blueberry Extract and Whole Blueberry Powder Confections in Healthy Men and Women
This trial studies how well a group of compounds found in blueberries called anthocyanins are absorbed into the body from 2 different types of blueberry confections (blueberry extract and whole blueberry powder). Blueberries contain several compounds which may be beneficial for human health and prevention of disease. These compounds can be consumed as part of a complex matrix in the whole fruit or also in a simplified matrix in the form of a fruit extract. Studying the absorption and metabolism of these compounds may help researchers understand how they influence health and disease, as well as determining the role of the food matrix on absorption of berry phytochemical.
Read the detailed description
PRIMARY OBJECTIVES:
- Compare urinary flavonoids composition, compliance and sensory acceptability of 2 blueberry-based amorphous functional confections one containing blueberry extract and the other of a whole blueberry powder) formulated to deliver the 320 mg of anthocyanins.
II. Assess the effect of blueberry source (extract versus [vs] whole fruit powder) on urinary metabolomics profile.
OUTLINE: Participants are randomized to of 2 groups.
GROUP I: Participants undergo a washout on days -7 to -1 and then consume blueberry extract confection on day 0. Participants undergo a second washout on days 1-7 and then consume blueberry powder confection on day 8.
GROUP II. Participants undergo a washout on days -7 to -1 and then consume blueberry powder confection on day 0. Participants undergo a second washout on days 1-7 and then consume blueberry extract confection on day 8.
- Conditions
- Healthy Diet, Nutrition Aspect of Cancer
- Being tested
- Blueberry Powder Food Product, Dietary Intervention, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blueberry Powder Food ProductOther
Consume blueberry powder confection
Dietary InterventionOther
Also called Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions
Consume blueberry extract confection
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Group I (blueberry extract, blueberry powder) | Experimental | Participants undergo a washout on days -7 to -1 and then consume blueberry extract confection on day 0. Participants undergo a second washout on days 1-7 and then consume blueberry powder confection on day 8. Receives: Other: Blueberry Powder Food Product; Other: Dietary Intervention; Other: Questionnaire Administration |
| Group II (blueberry powder, blueberry extract) | Experimental | Participants undergo a washout on days -7 to -1 and then consume blueberry powder confection on day 0. Participants undergo a second washout on days 1-7 and then consume blueberry extract confection on day 8. Receives: Other: Blueberry Powder Food Product; Other: Dietary Intervention; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
Means +/- SD (standard deviation) will be used to express the results from acceptability tests, and differences in acceptability of the two confections will be determined using paired t tests using the SPSS statistical software package.
Measured: Day 0 of each arm
Acceptability
Means +/- SD (standard deviation) will be used to express the results from acceptability tests, and differences in acceptability of the two confections will be determined using paired t tests using the SPSS statistical software package.
Measured: Day 8 of each arm
Bioavailability of the various berry interventions
Will measure bioavailability of the various berry interventions using high performance liquid chromatography (HPLC) analysis of blueberry phytochemicals and metabolites in urine at the day 1 timepoint, after consumption of the test product. Baseline comparisons for anthocyanins found in urine between trials will be performed a paired t-test. Total anthocyanins in 24-hour urine after consumption of one blueberry treatment will be compared to each participant's baseline urine and to total anthocyanins after consumption of the blueberry treatment in a paired t-test.
Measured: Day 1 of each arm
Bioavailability of the various berry interventions
Will measure bioavailability of the various berry interventions using high performance liquid chromatography (HPLC) analysis of blueberry phytochemicals and metabolites in urine at the day 8 timepoints. Baseline comparisons for anthocyanins found in urine between trials will be performed a paired t-test. Total anthocyanins in 24-hour urine after consumption of one blueberry treatment will be compared to each participant's baseline urine and to total anthocyanins after consumption of the blueberry treatment in a paired t-test.
Measured: Day 8 of each arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start8 May 2018
- Primary completion14 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy DietStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yael Vodovotz, Ohio State University Comprehensive Cancer Center
- Investigators
- Yael Vodovotz, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04329962
- Sponsor's protocol ID
- OSU-18010
- Other IDs
- NCI-2020-01525
- Status last verified
- Jul 2026
- First submitted
- 25 Mar 2020
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Bioavailability and Urinary Metabolite Profile After Consumption of Blueberry Extract and Whole Blueberry Powder Confections in Healthy Men and Women
- ClinicalTrials.gov ID
- NCT04329962
- Acronym / sponsor ID
- OSU-18010
- Conditions
- Healthy Diet, Nutrition Aspect of Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 8 May 2018 (actual)
- Primary completion
- 14 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 1 Apr 2020 (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 trial studies how well a group of compounds found in blueberries called anthocyanins are absorbed into the body from 2 different types of blueberry confections (blueberry extract and whole blueberry powder). Blueberries contain several compounds which may be beneficial for human health and prevention of disease. These compounds can be consumed as part of a complex matrix in the whole fruit or also in a simplified matrix in the form of a fruit extract. Studying the absorption and metabolism of these compounds may help researchers understand how they influence health and disease, as well as determining the role of the food matrix on absorption of berry phytochemical.
Detailed description
PRIMARY OBJECTIVES:
- Compare urinary flavonoids composition, compliance and sensory acceptability of 2 blueberry-based amorphous functional confections one containing blueberry extract and the other of a whole blueberry powder) formulated to deliver the 320 mg of anthocyanins.
II. Assess the effect of blueberry source (extract versus [vs] whole fruit powder) on urinary metabolomics profile.
OUTLINE: Participants are randomized to of 2 groups.
GROUP I: Participants undergo a washout on days -7 to -1 and then consume blueberry extract confection on day 0. Participants undergo a second washout on days 1-7 and then consume blueberry powder confection on day 8.
GROUP II. Participants undergo a washout on days -7 to -1 and then consume blueberry powder confection on day 0. Participants undergo a second washout on days 1-7 and then consume blueberry extract confection on day 8.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (blueberry extract, blueberry powder) | Experimental | Other: Blueberry Powder Food Product, Other: Dietary Intervention, Other: Questionnaire AdministrationParticipants undergo a washout on days -7 to -1 and then consume blueberry extract confection on day 0. Participants undergo a second washout on days 1-7 and then consume blueberry powder confection on day 8. |
| Group II (blueberry powder, blueberry extract) | Experimental | Other: Blueberry Powder Food Product, Other: Dietary Intervention, Other: Questionnaire AdministrationParticipants undergo a washout on days -7 to -1 and then consume blueberry powder confection on day 0. Participants undergo a second washout on days 1-7 and then consume blueberry extract confection on day 8. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be healthy, free-living adults
- Have a body mass index (BMI) between 18 and 35 kg/m^2
- Be a non-smoker (defined as adults who have never smoked or who have not had a cigarette in the past ten years)
- Agree to follow a berry-restricted diet and to document any accidental consumption of restricted foods each day of the study
Key exclusion criteria (6 listed)
- Report being actively treated for any metabolic, digestive or immunologic disorder including malabsorptive disorders, renal insufficiency, hepatic insufficiency, any autoimmune disorder or short bowel syndrome
- Have a known allergy or food intolerance to ingredients in study products (blueberries), other berries, wheat, or soy
- Are strict vegans (no consumption of animal, fish or egg products)
- Are planning to conceive, or are currently pregnant or lactating
- Are heavy alcohol consumers (defined as an average consumption of greater than 2 drinks/ day)
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 |
|---|---|---|
| Blueberry Powder Food ProductConsume blueberry powder confection | Other | Group I (blueberry extract, blueberry powder), Group II (blueberry powder, blueberry extract) |
| Dietary InterventionAlso: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition InterventionsConsume blueberry extract confection | Other | Group I (blueberry extract, blueberry powder), Group II (blueberry powder, blueberry extract) |
| Questionnaire AdministrationAncillary studies | Other | Group I (blueberry extract, blueberry powder), Group II (blueberry powder, blueberry extract) |
Primary outcome
Acceptability
Time frame: Day 0 of each arm
Means +/- SD (standard deviation) will be used to express the results from acceptability tests, and differences in acceptability of the two confections will be determined using paired t tests using the SPSS statistical software package.
Acceptability
Time frame: Day 8 of each arm
Means +/- SD (standard deviation) will be used to express the results from acceptability tests, and differences in acceptability of the two confections will be determined using paired t tests using the SPSS statistical software package.
Bioavailability of the various berry interventions
Time frame: Day 1 of each arm
Will measure bioavailability of the various berry interventions using high performance liquid chromatography (HPLC) analysis of blueberry phytochemicals and metabolites in urine at the day 1 timepoint, after consumption of the test product. Baseline comparisons for anthocyanins found in urine between trials will be performed a paired t-test. Total anthocyanins in 24-hour urine after consumption of one blueberry treatment will be compared to each participant's baseline urine and to total anthocyanins after consumption of the blueberry treatment in a paired t-test.
Bioavailability of the various berry interventions
Time frame: Day 8 of each arm
Will measure bioavailability of the various berry interventions using high performance liquid chromatography (HPLC) analysis of blueberry phytochemicals and metabolites in urine at the day 8 timepoints. Baseline comparisons for anthocyanins found in urine between trials will be performed a paired t-test. Total anthocyanins in 24-hour urine after consumption of one blueberry treatment will be compared to each participant's baseline urine and to total anthocyanins after consumption of the blueberry treatment in a paired t-test.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Yael Vodovotz principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blueberry Powder Food Product, Dietary Intervention and Questionnaire Administration in people with Healthy Diet and Nutrition Aspect of Cancer, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 30 Jul 2026. 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 States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Acceptability (time frame: Day 0 of each arm). The study lists 4 primary outcomes in all. 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 30 Jul 2026.