TrialReader


Enhancing the Benefits of Blueberry Polyphenols With Protein

NCT05967897 — Not applicable, Completed, 19 participants, Colorado State University

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

Enhancing the Benefits of Blueberry Polyphenols With Plant and Whey Proteins

RegistryNCT05967897
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, crossover, masking: single, basic science
Enrollment19 (Actual)
SponsorColorado State University (Other); collaborators: United States Department of Agriculture (USDA)
ConditionsHealthy Adults
InterventionsBlueberries, Blueberries and Whey Protein, Blueberries and Pea Protein, Blueberries and Hemp Protein (Dietary supplement)
Datesstart 2023-03-09, primary completion 2023-07-26, completion 2024-06-01, first posted 2023-08-01, last updated 2024-06-06
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Healthy Adults All trials of Blueberries All trials of Blueberries and Whey Protein

-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.

Expand all sections  ·  Collapse all

+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.

+Arms and interventions

ArmTypeInterventionsDescription
BlueberriesExperimentalDietary Supplement: BlueberriesFreeze-dried blueberry powder
Blueberries and Whey ProteinActive comparatorDietary Supplement: Blueberries and Whey ProteinFreeze-dried blueberry powder and whey protein
Blueberries and Pea ProteinActive comparatorDietary Supplement: Blueberries and Pea ProteinFreeze-dried blueberry powder and pea protein
Blueberries and Hemp ProteinActive comparatorDietary Supplement: Blueberries and Hemp ProteinFreeze-dried blueberry powder and hemp protein
  • 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

+Outcome measures

Primary outcomes

  • Plasma polyphenol metabolites [Change from 0 hours (pre-treatment consumption) to 1 hour post-treatment consumption]: Plasma polyphenol metabolite analysis using mass spectrometry
  • Plasma polyphenol metabolites [Change from 0 hours (pre-treatment consumption) to 2 hours post-treatment consumption]: Plasma polyphenol metabolite analysis using mass spectrometry
  • Plasma polyphenol metabolites [Change from 0 hours (pre-treatment consumption) to 4 hours post-treatment consumption]: Plasma polyphenol metabolite analysis using mass spectrometry
  • Plasma polyphenol metabolites [Change from 0 hours (pre-treatment consumption) to 6 hours post-treatment consumption]: Plasma polyphenol metabolite analysis using mass spectrometry
  • Plasma polyphenol metabolites [Change from 0 hours (pre-treatment consumption) to 24 hours post-treatment consumption]: Plasma polyphenol metabolite analysis using mass spectrometry

Secondary outcomes

  • Urine polyphenol metabolites [0 hours (pre-treatment consumption) and 24 hours post-treatment consumption]: Urine polyphenol metabolite analysis using mass spectrometry

Other outcomes

  • Gut microbial analysis [0 hours (pre-treatment consumption) and 24 hours post-treatment consumption]: 16S rRNA gene sequencing
  • Blood pressure [0 hours (pre-treatment consumption) and 1, 2, 4, and 6 hours post-treatment consumption]: Brachial blood pressure parameters (systolic, diastolic, and pulse pressure)
  • Aortic pressure [0 hours (pre-treatment consumption) and 1, 2, 4, and 6 hours post-treatment consumption]: Aortic pressure parameters (systolic pressure, aortic pressure, pulse pressure)
  • Augmentation index [0 hours (pre-treatment consumption) and 1, 2, 4, and 6 hours post-treatment consumption]: Augmentation index measured via SphygmoCor Xcel
  • Glucose [0 hours (pre-treatment consumption) and 1, 2, 4, 6, and 24 hours post-treatment consumption]: Blood glucose will be assessed using standard assays
  • Insulin [0 hours (pre-treatment consumption) and 1, 2, 4, 6, and 24 hours post-treatment consumption]: Blood insulin will be assessed using standard assays
  • Nitric oxide metabolites [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

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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.

+Locations (1)

FacilityCityCountryStatus
Food and Nutrition Clinical Research Laboratory - CSU Gifford BuildingFort Collins, ColoradoUnited States

+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. PMID 36140972

+Investigators

  • 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

My Notes