Clinical trial NCT05967897: Enhancing the Benefits of Blueberry Polyphenols With Protein
Official title: Enhancing the Benefits of Blueberry Polyphenols With Plant and Whey Proteins
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Adults
Keywords: Healthy
Adults
Blueberries
Polyphenols
Protein
Bioavailability
Lead sponsor: Colorado State University
Sponsor class: OTHER
Collaborators: name: United States Department of Agriculture (USDA)
First posted: 2023-08-01
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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.

Primary outcomes:
measure: Plasma polyphenol metabolites
timeFrame: Change from 0 hours (pre-treatment consumption) to 1 hour post-treatment consumption
measure: Plasma polyphenol metabolites
timeFrame: Change from 0 hours (pre-treatment consumption) to 2 hours post-treatment consumption
measure: Plasma polyphenol metabolites
timeFrame: Change from 0 hours (pre-treatment consumption) to 4 hours post-treatment consumption
measure: Plasma polyphenol metabolites
timeFrame: Change from 0 hours (pre-treatment consumption) to 6 hours post-treatment consumption
measure: Plasma polyphenol metabolites
timeFrame: Change from 0 hours (pre-treatment consumption) to 24 hours post-treatment consumption
Secondary outcomes:
measure: Urine polyphenol metabolites
timeFrame: 0 hours (pre-treatment consumption) and 24 hours post-treatment consumption
Other outcomes:
measure: Gut microbial analysis
timeFrame: 0 hours (pre-treatment consumption) and 24 hours post-treatment consumption
measure: Blood pressure
timeFrame: 0 hours (pre-treatment consumption) and 1, 2, 4, and 6 hours post-treatment consumption
measure: Aortic pressure
timeFrame: 0 hours (pre-treatment consumption) and 1, 2, 4, and 6 hours post-treatment consumption
measure: Augmentation index
timeFrame: 0 hours (pre-treatment consumption) and 1, 2, 4, and 6 hours post-treatment consumption
measure: Glucose
timeFrame: 0 hours (pre-treatment consumption) and 1, 2, 4, 6, and 24 hours post-treatment consumption
measure: Insulin
timeFrame: 0 hours (pre-treatment consumption) and 1, 2, 4, 6, and 24 hours post-treatment consumption
measure: Nitric oxide metabolites
timeFrame: 0 hours (pre-treatment consumption) and 1, 2, 4, 6, and 24 hours post-treatment consumption
Locations:
city: Fort Collins
country: United States
facility: Food and Nutrition Clinical Research Laboratory - CSU Gifford Building
state: Colorado
Study officials:
affiliation: Colorado State University, Department of Food Science and Human Nutrition
name: Sarah A Johnson, PhD, RDN
role: PRINCIPAL_INVESTIGATOR
affiliation: Colorado State University, Department of Food Science and Human Nutrition
name: Charlene Van Buiten, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.