Healthy Adults Clinical Trial
Official title:
Enhancing the Benefits of Blueberry Polyphenols With Plant and Whey Proteins
NCT number | NCT05967897 |
Other study ID # | 3647 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 9, 2023 |
Est. completion date | June 1, 2024 |
Verified date | June 2024 |
Source | Colorado State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 19 |
Est. completion date | June 1, 2024 |
Est. primary completion date | July 26, 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. |
Country | Name | City | State |
---|---|---|---|
United States | Food and Nutrition Clinical Research Laboratory - CSU Gifford Building | Fort Collins | Colorado |
Lead Sponsor | Collaborator |
---|---|
Colorado State University | United States Department of Agriculture (USDA) |
United States,
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
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