Enhancing the Benefits of Blueberry Polyphenols With Protein
1 other identifier
interventional
19
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 9, 2023
CompletedFirst Submitted
Initial submission to the registry
June 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 26, 2023
CompletedFirst Posted
Study publicly available on registry
August 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedJune 6, 2024
June 1, 2024
5 months
June 22, 2023
June 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Plasma polyphenol metabolites
Plasma polyphenol metabolite analysis using mass spectrometry
Change from 0 hours (pre-treatment consumption) to 1 hour post-treatment consumption
Plasma polyphenol metabolites
Plasma polyphenol metabolite analysis using mass spectrometry
Change from 0 hours (pre-treatment consumption) to 2 hours post-treatment consumption
Plasma polyphenol metabolites
Plasma polyphenol metabolite analysis using mass spectrometry
Change from 0 hours (pre-treatment consumption) to 4 hours post-treatment consumption
Plasma polyphenol metabolites
Plasma polyphenol metabolite analysis using mass spectrometry
Change from 0 hours (pre-treatment consumption) to 6 hours post-treatment consumption
Plasma polyphenol metabolites
Plasma polyphenol metabolite analysis using mass spectrometry
Change from 0 hours (pre-treatment consumption) to 24 hours post-treatment consumption
Secondary Outcomes (1)
Urine polyphenol metabolites
0 hours (pre-treatment consumption) and 24 hours post-treatment consumption
Other Outcomes (7)
Gut microbial analysis
0 hours (pre-treatment consumption) and 24 hours post-treatment consumption
Blood pressure
0 hours (pre-treatment consumption) and 1, 2, 4, and 6 hours post-treatment consumption
Aortic pressure
0 hours (pre-treatment consumption) and 1, 2, 4, and 6 hours post-treatment consumption
- +4 more other outcomes
Study Arms (4)
Blueberries
EXPERIMENTALFreeze-dried blueberry powder
Blueberries and Whey Protein
ACTIVE COMPARATORFreeze-dried blueberry powder and whey protein
Blueberries and Pea Protein
ACTIVE COMPARATORFreeze-dried blueberry powder and pea protein
Blueberries and Hemp Protein
ACTIVE COMPARATORFreeze-dried blueberry powder and hemp protein
Interventions
22 g freeze-dried blueberry powder mixed with whey protein and water
22 g freeze-dried blueberry powder mixed with pea protein and water
22 g freeze-dried blueberry powder mixed with hemp protein and water
Eligibility Criteria
You may qualify if:
- Aged 18 years or older
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Food and Nutrition Clinical Research Laboratory - CSU Gifford Building
Fort Collins, Colorado, 80523-1571, United States
Related 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.
PMID: 36140972BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2023
First Posted
August 1, 2023
Study Start
March 9, 2023
Primary Completion
July 26, 2023
Study Completion
June 1, 2024
Last Updated
June 6, 2024
Record last verified: 2024-06