- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05967897
Enhancing the Benefits of Blueberry Polyphenols With Protein
Enhancing the Benefits of Blueberry Polyphenols With Plant and Whey Proteins
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Colorado
-
Fort Collins, Colorado, United States, 80523-1571
- Food and Nutrition Clinical Research Laboratory - CSU Gifford Building
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 18 years or older
Exclusion Criteria:
• 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
- >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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Blueberries
Freeze-dried blueberry powder
|
22 g freeze-dried blueberry powder mixed with water
|
|
Active Comparator: Blueberries and Whey Protein
Freeze-dried blueberry powder and whey protein
|
22 g freeze-dried blueberry powder mixed with whey protein and water
|
|
Active Comparator: Blueberries and Pea Protein
Freeze-dried blueberry powder and pea protein
|
22 g freeze-dried blueberry powder mixed with pea protein and water
|
|
Active Comparator: Blueberries and Hemp Protein
Freeze-dried blueberry powder and hemp protein
|
22 g freeze-dried blueberry powder mixed with hemp protein and water
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Change from 0 hours (pre-treatment consumption) to 1 hour post-treatment consumption
|
|
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
|
Change from 0 hours (pre-treatment consumption) to 2 hours post-treatment consumption
|
|
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
|
Change from 0 hours (pre-treatment consumption) to 4 hours post-treatment consumption
|
|
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
|
Change from 0 hours (pre-treatment consumption) to 6 hours post-treatment consumption
|
|
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
|
Change from 0 hours (pre-treatment consumption) to 24 hours post-treatment consumption
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Urine polyphenol metabolites
Time Frame: 0 hours (pre-treatment consumption) and 24 hours post-treatment consumption
|
Urine polyphenol metabolite analysis using mass spectrometry
|
0 hours (pre-treatment consumption) and 24 hours post-treatment consumption
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gut microbial analysis
Time Frame: 0 hours (pre-treatment consumption) and 24 hours post-treatment consumption
|
16S rRNA gene sequencing
|
0 hours (pre-treatment consumption) and 24 hours post-treatment consumption
|
|
Blood pressure
Time Frame: 0 hours (pre-treatment consumption) and 1, 2, 4, and 6 hours post-treatment consumption
|
Brachial blood pressure parameters (systolic, diastolic, and pulse pressure)
|
0 hours (pre-treatment consumption) and 1, 2, 4, and 6 hours post-treatment consumption
|
|
Aortic pressure
Time Frame: 0 hours (pre-treatment consumption) and 1, 2, 4, and 6 hours post-treatment consumption
|
Aortic pressure parameters (systolic pressure, aortic pressure, pulse pressure)
|
0 hours (pre-treatment consumption) and 1, 2, 4, and 6 hours post-treatment consumption
|
|
Augmentation index
Time Frame: 0 hours (pre-treatment consumption) and 1, 2, 4, and 6 hours post-treatment consumption
|
Augmentation index measured via SphygmoCor Xcel
|
0 hours (pre-treatment consumption) and 1, 2, 4, and 6 hours post-treatment consumption
|
|
Glucose
Time Frame: 0 hours (pre-treatment consumption) and 1, 2, 4, 6, and 24 hours post-treatment consumption
|
Blood glucose will be assessed using standard assays
|
0 hours (pre-treatment consumption) and 1, 2, 4, 6, and 24 hours post-treatment consumption
|
|
Insulin
Time Frame: 0 hours (pre-treatment consumption) and 1, 2, 4, 6, and 24 hours post-treatment consumption
|
Blood insulin will be assessed using standard assays
|
0 hours (pre-treatment consumption) and 1, 2, 4, 6, and 24 hours post-treatment consumption
|
|
Nitric oxide metabolites
Time Frame: 0 hours (pre-treatment consumption) and 1, 2, 4, 6, and 24 hours post-treatment consumption
|
Blood nitric oxide metabolites will be assessed using standard assays
|
0 hours (pre-treatment consumption) and 1, 2, 4, 6, and 24 hours post-treatment consumption
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sarah A Johnson, PhD, RDN, Colorado State University, Department of Food Science and Human Nutrition
- Principal Investigator: Charlene Van Buiten, PhD, Colorado State University, Department of Food Science and Human Nutrition
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 3647
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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