Enhancing the Benefits of Blueberry Polyphenols With Protein

Sponsor

Colorado State University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05967897

Collaborator

United States Department of Agriculture (USDA) (U.S. Fed)

Enrollment

Location

Arms

14.8

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

Anticipated 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 :

Mar 9, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

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

Primary Outcome Measures

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 Outcome Measures

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

Other Outcome Measures

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 Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Food and Nutrition Clinical Research Laboratory - CSU Gifford Building	Fort Collins	Colorado	United States	80523-1571

Sponsors and Collaborators

Colorado State University
United States Department of Agriculture (USDA)

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