Enhancing the Benefits of Blueberry Polyphenols With Protein

Healthy Adults Clinical Trial

Official title:

Enhancing the Benefits of Blueberry Polyphenols With Plant and Whey Proteins

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05967897
• Other study ID #: 3647
• Status: Recruiting
• Phase: N/A
• Start date: March 9, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: July 2023
• Source: Colorado State University
• Contact: Afsana Khandaker, MBBS, MS
• Phone: 970-491-0464
• Email: afsana.khandaker[@]colostate.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: June 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Adults

Intervention

Dietary Supplement:
• Blueberries
22 g freeze-dried blueberry powder mixed with water
• Blueberries and Whey Protein
22 g freeze-dried blueberry powder mixed with whey protein and water
• Blueberries and Pea Protein
22 g freeze-dried blueberry powder mixed with pea protein and water
• Blueberries and Hemp Protein
22 g freeze-dried blueberry powder mixed with hemp protein and water

Locations

Country	Name	City	State
United States	Food and Nutrition Clinical Research Laboratory - CSU Gifford Building	Fort Collins	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Colorado State University	United States Department of Agriculture (USDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gut microbial analysis	16S rRNA gene sequencing	0 hours (pre-treatment consumption) and 24 hours post-treatment consumption
Other	Blood pressure	Brachial blood pressure parameters (systolic, diastolic, and pulse pressure)	0 hours (pre-treatment consumption) and 1, 2, 4, and 6 hours post-treatment consumption
Other	Aortic pressure	Aortic pressure parameters (systolic pressure, aortic pressure, pulse pressure)	0 hours (pre-treatment consumption) and 1, 2, 4, and 6 hours post-treatment consumption
Other	Augmentation index	Augmentation index measured via SphygmoCor Xcel	0 hours (pre-treatment consumption) and 1, 2, 4, and 6 hours post-treatment consumption
Other	Glucose	Blood glucose will be assessed using standard assays	0 hours (pre-treatment consumption) and 1, 2, 4, 6, and 24 hours post-treatment consumption
Other	Insulin	Blood insulin will be assessed using standard assays	0 hours (pre-treatment consumption) and 1, 2, 4, 6, and 24 hours post-treatment consumption
Other	Nitric oxide metabolites	Blood nitric oxide metabolites will be assessed using standard assays	0 hours (pre-treatment consumption) and 1, 2, 4, 6, and 24 hours post-treatment consumption
Primary	Plasma polyphenol metabolites	Plasma polyphenol metabolite analysis using mass spectrometry	Change from 0 hours (pre-treatment consumption) to 1 hour post-treatment consumption
Primary	Plasma polyphenol metabolites	Plasma polyphenol metabolite analysis using mass spectrometry	Change from 0 hours (pre-treatment consumption) to 2 hours post-treatment consumption
Primary	Plasma polyphenol metabolites	Plasma polyphenol metabolite analysis using mass spectrometry	Change from 0 hours (pre-treatment consumption) to 4 hours post-treatment consumption
Primary	Plasma polyphenol metabolites	Plasma polyphenol metabolite analysis using mass spectrometry	Change from 0 hours (pre-treatment consumption) to 6 hours post-treatment consumption
Primary	Plasma polyphenol metabolites	Plasma polyphenol metabolite analysis using mass spectrometry	Change from 0 hours (pre-treatment consumption) to 24 hours post-treatment consumption
Secondary	Urine polyphenol metabolites	Urine polyphenol metabolite analysis using mass spectrometry	0 hours (pre-treatment consumption) and 24 hours post-treatment consumption