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Enhancing the Benefits of Blueberry Polyphenols With Protein

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ClinicalTrials.gov Identifier: NCT05967897
Recruitment Status : Recruiting
First Posted : August 1, 2023
Last Update Posted : August 1, 2023
Sponsor:
Collaborator:
United States Department of Agriculture (USDA)
Information provided by (Responsible Party):
Colorado State University

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
Healthy Adults Dietary Supplement: Blueberries Dietary Supplement: Blueberries and Whey Protein Dietary Supplement: Blueberries and Pea Protein Dietary Supplement: Blueberries and Hemp Protein Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Enhancing the Benefits of Blueberry Polyphenols With Plant and Whey Proteins
Actual Study Start Date : March 9, 2023
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : June 1, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Blueberries
Freeze-dried blueberry powder
 Dietary Supplement: Blueberries
22 g freeze-dried blueberry powder mixed with water
Active Comparator: Blueberries and Whey Protein
Freeze-dried blueberry powder and whey protein
 Dietary Supplement: Blueberries 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
 Dietary Supplement: Blueberries 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
 Dietary Supplement: Blueberries and Hemp Protein
22 g freeze-dried blueberry powder mixed with hemp protein and water


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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


Secondary Outcome Measures :
  1. Urine polyphenol metabolites [ Time Frame: 0 hours (pre-treatment consumption) and 24 hours post-treatment consumption ]
    Urine polyphenol metabolite analysis using mass spectrometry


Other Outcome Measures:
  1. Gut microbial analysis [ Time Frame: 0 hours (pre-treatment consumption) and 24 hours post-treatment consumption ]
    16S rRNA gene sequencing

  2. 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)

  3. 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)

  4. 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

  5. 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

  6. 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

  7. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05967897


Contacts
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Contact: Afsana Khandaker, MBBS, MS 970-491-0464 afsana.khandaker@colostate.edu
Contact: Sarah A Johnson, PhD, RDN 970-491-3807 sarah.johnson@colostate.edu

Locations
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United States, Colorado
Food and Nutrition Clinical Research Laboratory - CSU Gifford Building Recruiting
Fort Collins, Colorado, United States, 80523-1571
Contact: Sarah A Johnson, PhD, RDN    970-491-3807    sarah.johnson@colostate.edu   
Principal Investigator: Sarah A Johnson, PhD, RDN         
Sponsors and Collaborators
Colorado State University
United States Department of Agriculture (USDA)
Investigators
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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
More Information
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Publications:

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Responsible Party: Colorado State University
ClinicalTrials.gov Identifier: NCT05967897    
Other Study ID Numbers: 3647
First Posted: August 1, 2023    Key Record Dates
Last Update Posted: August 1, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Colorado State University:
Healthy
Adults
Blueberries
 Polyphenols
Protein
Bioavailability