Healthy AdultsNCT05967897
Enhancing the Benefits of Blueberry Polyphenols With Protein
A study testing Blueberries, Blueberries and Whey Protein and Blueberries and Pea Protein in people with Healthy Adults, run by Colorado State University at 1 site in United States.
Trial summary
The purpose of this randomized crossover trial is determine whether acute consumption of blueberries with different proteins from plants (hemp or pea) or dairy (whey) impact the absorption of blueberry phytochemicals, which could impact the health benefits of blueberries. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- Blueberries, Blueberries and Whey Protein and Blueberries and Pea Protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2023to 1 Jun 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
Who cannot join
- • Blood levels of HbA1c ≥ 6.5%, total cholesterol ≥ 240 mg/dL, LDL cholesterol ≥ 130 mg/dL, triglycerides ≥ 200 mg/dL
- Are anemic (hemoglobin less than 13.5 g/dL in men and 12.0 g/dL in women)
- Have an average blood pressure greater than or equal to 130/80 mmHg, or have diagnosed hypertension, hyperlipidemia, cardiovascular disease, diabetes, cancer, kidney, liver, gastrointestinal or pancreatic disease
- Taking blood pressure-, lipid- or glucose-lowering, or hormone replacement medications
- Are pregnant or are trying to become pregnant
- Have a body mass index < 18.5 or > 30 kg/m2
Show all 12Show fewer
- >3 days/week vigorous exercise
- Are not willing to maintain your normal eating/drinking and exercise habits over the duration of the study
- History of smoking cigarettes in past 12 months
- Binge and/or heavy drinker (>3 drinks on any given occasion and/or >7 drinks/week for women, and >4 drinks on any given occasion and/or >14 drinks/week for men)
- Have allergies or contraindication to study treatments, procedures, or procedure supplies
- Unable to attend study visits.
Trial locations and contacts
1 site in 1 country.
United States1 site
Food and Nutrition Clinical Research Laboratory - CSU Gifford Building
Fort Collins, Colorado, 80523-1571
About this study
Official title: Enhancing the Benefits of Blueberry Polyphenols With Plant and Whey Proteins
The purpose of this randomized crossover trial is determine whether acute consumption of blueberries with different proteins from plants (hemp or pea) or dairy (whey) impact the absorption of blueberry phytochemicals, which could impact the health benefits of blueberries. A secondary purpose is to understand the role that the gut microbiome may play, as well as the impact on urine polyphenol metabolites and potential implications for cardiometabolic health. Researchers will compare four arms: 1) Blueberries; 2) Blueberries + whey protein; 3) Blueberries + pea protein; and 4) Blueberries + hemp protein.
Read the detailed description
Polyphenols are a structurally diverse class of secondary metabolites found in plants, with numerous documented benefits for human health including, but not limited to, anti-inflammatory, antioxidative and cardiovascular-protective effects. Dietary intake of polyphenols in the United States is low in comparison to other developed countries due to low intake of fruits and vegetables. Recent studies suggest fruit and vegetable intake should be increased by incorporating those foods into snacks and mixed meals as ingredients rather than standalone food items. Presently, berries comprise 10% of the total fruit intake and 7% of the total polyphenol intake of American adults. As a versatile food ingredient, berries can easily be added to foods like smoothies and yogurts as an ingredient to increase intake.
Low polyphenol intake is an issue exacerbated by poor bioavailability. Consumption does not necessarily mean that these beneficial compounds are delivered to body tissues, as evidenced by low levels of detection in blood and accumulation in the lower gastrointestinal tract after feeding. Bioavailability can be enhanced through the complexation of polyphenols with proteins, a phenomenon which occurs naturally in complex mixtures including both classes of nutrients. It has been shown that the complexation of polyphenols with proteins in cow's milk, known as a "matrix effect", enhances the polyphenol stability and uptake throughout digestion. The incorporation of berries into complex food mixtures may not only be an opportunity for improved health outcomes due to increased polyphenol intake, but also an effective strategy for ensuring that consumers receive the benefits of the nutrients they consume.
It is unknown whether the beneficial matrix effects observed when polyphenols interact with dairy proteins are exclusive to dairy proteins due to characteristics of high digestibility or structures which favor phenolic interaction, or if similar effects would be observed with proteins from other sources. Increasing consumer demand for alternative protein sources for reasons pertaining to human health and environmental sustainability has introduced a variety of novel plant-based proteins to the American diet, which may elicit similarly advantageous matrix effects on the bioavailability of polyphenols depending on their digestibility and structural characteristics. Understanding protein-polyphenol interactions in novel food matrices is necessary for the development of food products that promote polyphenol consumption and bioavailability with the aim to improve human health.
- Conditions
- Healthy Adults
- Being tested
- Blueberries, Blueberries and Whey Protein, Blueberries and Pea Protein, Blueberries and Hemp Protein
- Keywords
- Healthy, Adults, Blueberries, Polyphenols, Protein, Bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlueberriesDietary supplement
22 g freeze-dried blueberry powder mixed with water
Blueberries and Whey ProteinDietary supplement
22 g freeze-dried blueberry powder mixed with whey protein and water
Blueberries and Pea ProteinDietary supplement
22 g freeze-dried blueberry powder mixed with pea protein and water
Blueberries and Hemp ProteinDietary supplement
22 g freeze-dried blueberry powder mixed with hemp protein and water
| Study group | Role | What they receive |
|---|---|---|
| Blueberries | Experimental | Freeze-dried blueberry powder Receives: Dietary Supplement: Blueberries |
| Blueberries and Whey Protein | Active comparator | Freeze-dried blueberry powder and whey protein Receives: Dietary Supplement: Blueberries and Whey Protein |
| Blueberries and Pea Protein | Active comparator | Freeze-dried blueberry powder and pea protein Receives: Dietary Supplement: Blueberries and Pea Protein |
| Blueberries and Hemp Protein | Active comparator | Freeze-dried blueberry powder and hemp protein Receives: Dietary Supplement: Blueberries and Hemp Protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma polyphenol metabolites
Plasma polyphenol metabolite analysis using mass spectrometry
Measured: Change from 0 hours (pre-treatment consumption) to 1 hour post-treatment consumption
Plasma polyphenol metabolites
Plasma polyphenol metabolite analysis using mass spectrometry
Measured: Change from 0 hours (pre-treatment consumption) to 2 hours post-treatment consumption
Plasma polyphenol metabolites
Plasma polyphenol metabolite analysis using mass spectrometry
Measured: Change from 0 hours (pre-treatment consumption) to 4 hours post-treatment consumption
Plasma polyphenol metabolites
Plasma polyphenol metabolite analysis using mass spectrometry
Measured: Change from 0 hours (pre-treatment consumption) to 6 hours post-treatment consumption
Plasma polyphenol metabolites
Plasma polyphenol metabolite analysis using mass spectrometry
Measured: Change from 0 hours (pre-treatment consumption) to 24 hours post-treatment consumption
Secondary outcomes (1)
Urine polyphenol metabolites
Urine polyphenol metabolite analysis using mass spectrometry
Measured: 0 hours (pre-treatment consumption) and 24 hours post-treatment consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start9 Mar 2023
- Primary completion26 Jul 2023
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy AdultsStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Responsible party
- Sponsor
- Investigators
- Sarah A Johnson, PhD, RDN, Principal investigator, Colorado State University, Department of Food Science and Human NutritionCharlene Van Buiten, PhD, Principal investigator, Colorado State University, Department of Food Science and Human Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05967897
- Sponsor's protocol ID
- 3647
- Status last verified
- Jun 2024
- First submitted
- 22 Jun 2023
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chima B, Mathews P, Morgan S, Johnson SA, Van Buiten CB. Physicochemical Characterization of Interactions between Blueberry Polyphenols and Food Proteins from Dairy and Plant Sources. Foods. 2022 Sep 14;11(18):2846. doi: 10.3390/foods11182846.
PubMed 36140972
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing the Benefits of Blueberry Polyphenols With Plant and Whey Proteins
- ClinicalTrials.gov ID
- NCT05967897
- Acronym / sponsor ID
- 3647
- Conditions
- Healthy Adults
- Keywords
- Healthy, Adults, Blueberries, Polyphenols, Protein, Bioavailability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- 26 Jul 2023 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 1 Aug 2023 (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.
The purpose of this randomized crossover trial is determine whether acute consumption of blueberries with different proteins from plants (hemp or pea) or dairy (whey) impact the absorption of blueberry phytochemicals, which could impact the health benefits of blueberries. A secondary purpose is to understand the role that the gut microbiome may play, as well as the impact on urine polyphenol metabolites and potential implications for cardiometabolic health. Researchers will compare four arms: 1) Blueberries; 2) Blueberries + whey protein; 3) Blueberries + pea protein; and 4) Blueberries + hemp protein.
Detailed description
Polyphenols are a structurally diverse class of secondary metabolites found in plants, with numerous documented benefits for human health including, but not limited to, anti-inflammatory, antioxidative and cardiovascular-protective effects. Dietary intake of polyphenols in the United States is low in comparison to other developed countries due to low intake of fruits and vegetables. Recent studies suggest fruit and vegetable intake should be increased by incorporating those foods into snacks and mixed meals as ingredients rather than standalone food items. Presently, berries comprise 10% of the total fruit intake and 7% of the total polyphenol intake of American adults. As a versatile food ingredient, berries can easily be added to foods like smoothies and yogurts as an ingredient to increase intake.
Low polyphenol intake is an issue exacerbated by poor bioavailability. Consumption does not necessarily mean that these beneficial compounds are delivered to body tissues, as evidenced by low levels of detection in blood and accumulation in the lower gastrointestinal tract after feeding. Bioavailability can be enhanced through the complexation of polyphenols with proteins, a phenomenon which occurs naturally in complex mixtures including both classes of nutrients. It has been shown that the complexation of polyphenols with proteins in cow's milk, known as a "matrix effect", enhances the polyphenol stability and uptake throughout digestion. The incorporation of berries into complex food mixtures may not only be an opportunity for improved health outcomes due to increased polyphenol intake, but also an effective strategy for ensuring that consumers receive the benefits of the nutrients they consume.
It is unknown whether the beneficial matrix effects observed when polyphenols interact with dairy proteins are exclusive to dairy proteins due to characteristics of high digestibility or structures which favor phenolic interaction, or if similar effects would be observed with proteins from other sources. Increasing consumer demand for alternative protein sources for reasons pertaining to human health and environmental sustainability has introduced a variety of novel plant-based proteins to the American diet, which may elicit similarly advantageous matrix effects on the bioavailability of polyphenols depending on their digestibility and structural characteristics. Understanding protein-polyphenol interactions in novel food matrices is necessary for the development of food products that promote polyphenol consumption and bioavailability with the aim to improve human health.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Blueberries | Experimental | Dietary Supplement: BlueberriesFreeze-dried blueberry powder |
| Blueberries and Whey Protein | Active comparator | Dietary Supplement: Blueberries and Whey ProteinFreeze-dried blueberry powder and whey protein |
| Blueberries and Pea Protein | Active comparator | Dietary Supplement: Blueberries and Pea ProteinFreeze-dried blueberry powder and pea protein |
| Blueberries and Hemp Protein | Active comparator | Dietary Supplement: Blueberries and Hemp ProteinFreeze-dried blueberry powder and hemp protein |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Aged 18 years or older
Key exclusion criteria (12 listed)
- • Blood levels of HbA1c ≥ 6.5%, total cholesterol ≥ 240 mg/dL, LDL cholesterol ≥ 130 mg/dL, triglycerides ≥ 200 mg/dL
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 |
|---|---|---|
| Blueberries22 g freeze-dried blueberry powder mixed with water | Dietary supplement | Blueberries |
| Blueberries and Whey Protein22 g freeze-dried blueberry powder mixed with whey protein and water | Dietary supplement | Blueberries and Whey Protein |
| Blueberries and Pea Protein22 g freeze-dried blueberry powder mixed with pea protein and water | Dietary supplement | Blueberries and Pea Protein |
| Blueberries and Hemp Protein22 g freeze-dried blueberry powder mixed with hemp protein and water | Dietary supplement | Blueberries and Hemp Protein |
Primary outcome
Plasma polyphenol metabolites
Time frame: Change from 0 hours (pre-treatment consumption) to 1 hour post-treatment consumption
Plasma polyphenol metabolite analysis using mass spectrometry
Plasma polyphenol metabolites
Time frame: Change from 0 hours (pre-treatment consumption) to 2 hours post-treatment consumption
Plasma polyphenol metabolite analysis using mass spectrometry
Plasma polyphenol metabolites
Time frame: Change from 0 hours (pre-treatment consumption) to 4 hours post-treatment consumption
Plasma polyphenol metabolite analysis using mass spectrometry
Plasma polyphenol metabolites
Time frame: Change from 0 hours (pre-treatment consumption) to 6 hours post-treatment consumption
Plasma polyphenol metabolite analysis using mass spectrometry
Plasma polyphenol metabolites
Time frame: Change from 0 hours (pre-treatment consumption) to 24 hours post-treatment consumption
Plasma polyphenol metabolite analysis using mass spectrometry
1 secondary outcome
Urine polyphenol metabolites
Time frame: 0 hours (pre-treatment consumption) and 24 hours post-treatment consumption
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 6 Jun 2024.
- Background: PubMed 36140972Chima B, Mathews P, Morgan S, Johnson SA, Van Buiten CB. Physicochemical Characterization of Interactions between Blueberry Polyphenols and Food Proteins from Dairy and Plant Sources. Foods. 2022 Sep 14;11(18):2846. doi: 10.3390/foods11182846.
- Individual participant dataSharing planned: Undecided
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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.
Sarah A Johnson, PhD, RDN principal investigator
Colorado State University, Department of Food Science and Human Nutrition
Charlene Van Buiten, PhD principal investigator
Colorado State University, Department of Food Science and Human Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blueberries, Blueberries and Whey Protein and Blueberries and Pea Protein in people with Healthy Adults, run by Colorado State University 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 1 inclusion and 12 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 6 Jun 2024. 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?
Plasma polyphenol metabolites (time frame: Change from 0 hours (pre-treatment consumption) to 1 hour post-treatment consumption). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05967897, which also lists 1 linked publication.
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 6 Jun 2024.