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Completed

NCT Number: NCT05967897

Enhancing the Benefits of Blueberry Polyphenols With Protein

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Food and Nutrition Clinical Research Laboratory - CSU Gifford Building

Fort Collins, Colorado, 80523-1571, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blueberries

Dietary Supplement

22 g freeze-dried blueberry powder mixed with water

Blueberries and Whey Protein

Dietary Supplement

22 g freeze-dried blueberry powder mixed with whey protein and water

Blueberries and Pea Protein

Dietary Supplement

22 g freeze-dried blueberry powder mixed with pea protein and water

Blueberries and Hemp Protein

Dietary Supplement

22 g freeze-dried blueberry powder mixed with hemp protein and water

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Colorado State University

Other

Collaborators

  • United States Department of Agriculture (USDA)

Registry information

Official study title

Enhancing the Benefits of Blueberry Polyphenols With Plant and Whey Proteins

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Aug 1, 2023
Registry last updated
Jun 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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