Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 120068 | Other Identifier | University of Connecticut |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this project is to determine whether chokeberry polyphenols mitigate cardiovascular disease risk in former smokers.
More than 31% of Connecticut adults are former smokers, which may contribute to the high cardiovascular disease (CVD) risk in this state. Atherosclerosis, a hallmark of CVD, is a progressive life-long process. Chronic cigarette smoking increases atherosclerosis and CVD risk. While smoking cessation may lower CVD risk, former smokers still are at high CVD risk. The mechanisms by which smoking accelerates atherosclerosis formation are not fully understood. This knowledge gap prevents development of informed interventions to reduce CVD risk in former smokers.
Previous work suggests smoking increases oxidative stress and leads to elevated CVD risk. Former smokers also have decreased antioxidants and markers of vascular function in the circulation, suggesting that despite cessation, smoking has a lingering adverse effect on CVD protective mechanisms. Chokeberry (Aronia melanocarpa) is a native Connecticut plant rich in polyphenol antioxidants and is a promising intervention for reducing CVD risk in former smokers. Chokeberries have diverse polyphenols such as anthocyanins, proanthocyanidins, resveratrol, quercetin, and chlorogenic acid. Chokeberry consumption improves dyslipidemia, inhibits inflammation, and reduces oxidative stress in humans and animals, all of which could contribute to the prevention of CVD in former smokers. Therefore, our central hypothesis is that dietary chokeberry polyphenols reduce CVD risk in former smokers by improving lipid profiles and inhibiting inflammation and oxidative stress. Our long-term goal is to define the mechanisms by which polyphenol antioxidants mitigate CVD risk. The overall goal of this project is to conduct a randomized placebo-controlled clinical trial to evaluate the cardio-protective effects of dietary chokeberry polyphenols in former smokers.
Our objectives are to determine 1) the effect of chokeberry polyphenols on plasma cholesterol and triglyceride levels and on gene expression involved in cholesterol metabolism; 2) the extent to which chokeberry improves antioxidant and vascular function in former smokers; and 3) the association of bioavailability of chokeberry polyphenols to changes in biomarkers of CVD risk.
Successful completion of this work will result in improved understanding of the role of dietary berry polyphenols to regulate lipid metabolism, inflammation and oxidative stress. Thus, this study will be an important step to developing dietary recommendations for individuals predisposed to CVD risk, particularly former smokers.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Color-matched rice powder pill | Placebo Comparator | Color-matched rice powder pill |
|
| Chokeberry extract capsule | Active Comparator | Chokeberry extract capsule |
|
| Chokeberry extract capsule (acute) | Experimental | Chokeberry extract capsule pharmacokinetics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chokeberry Extract | Dietary Supplement | Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| LDL Cholesterol | Change in LDL cholesterol from baseline after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Baseline, 6 weeks, 12 weeks of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Total Cholesterol | Change in fasting total cholesterol from baseline after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | 6 and 12 weeks after supplementation |
| HDL-cholesterol |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bradley W Bolling, PhD | University of Connecticut, University of Wisconsin-Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roy E. Jones Building | Storrs | Connecticut | 06269 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27283706 | Result | Xie L, Lee SG, Vance TM, Wang Y, Kim B, Lee JY, Chun OK, Bolling BW. Bioavailability of anthocyanins and colonic polyphenol metabolites following consumption of aronia berry extract. Food Chem. 2016 Nov 15;211:860-8. doi: 10.1016/j.foodchem.2016.05.122. Epub 2016 May 19. | |
| 28215316 | Result | Xie L, Vance T, Kim B, Lee SG, Caceres C, Wang Y, Hubert PA, Lee JY, Chun OK, Bolling BW. Aronia berry polyphenol consumption reduces plasma total and low-density lipoprotein cholesterol in former smokers without lowering biomarkers of inflammation and oxidative stress: a randomized controlled trial. Nutr Res. 2017 Jan;37:67-77. doi: 10.1016/j.nutres.2016.12.007. Epub 2016 Dec 10. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Color-matched Rice Powder Pill | Color-matched rice powder pill Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks |
| FG001 | Chokeberry Extract Capsule | Chokeberry extract capsule Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks. Chokeberry extract capsule, acute: Chokeberry extract capsule, 2 x 250 mg, one-time dose. |
| FG002 | Chaokeberry Extract Capsule (Acute) | Chokeberry extract capsule, acute: Chokeberry extract capsule, 2 x 250 mg, one-time dose. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Color-matched Rice Powder Pill | Color-matched rice powder pill Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks |
| BG001 | Chokeberry Extract Capsule |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | LDL Cholesterol | Change in LDL cholesterol from baseline after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Posted | Mean | Standard Error | mg/dL | Baseline, 6 weeks, 12 weeks of intervention |
|
During study intervention stage: 16 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Color-matched Rice Powder Pill | Color-matched rice powder pill Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bradley Bolling | University of Wisconsin-Madison, Department of Food Science | 608-890-0212 | bwbolling@wisc.edu |
Not provided
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo capsule | Dietary Supplement | Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks |
|
| Chokeberry extract capsule, acute | Dietary Supplement | Chokeberry extract capsule, 2 x 250 mg, one-time dose. |
|
Change in fasting plasma cholesterol from baseline after chronic supplemenation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
| 6 and 12 weeks after supplementation |
| Triglycerides | Change in fasting plasma triglycerides from baseline after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | 6 and 12 weeks after supplementation |
| Resting Systolic Blood Pressure | Change in resting systolic blood pressure after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Baseline, 6 weeks, and 12 weeks following intervention |
| Resting Diastolic Blood Pressure | Change in resting diastolic blood pressure after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Baseline, 6 weeks, and 12 weeks following intervention |
| Urinary F2-isoprostanes | Change in resting urinary F2-isoprostanes after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Baseline and 12 weeks following intervention |
| 3-hydroxy-3-methyl-glutaryl Coenzyme A Reductase (HMGR) | Monocyte messenger ribonucleic acid (mRNA) expression normalized to glyceraldehyde-3-phosphate dehydrogenase (GAPDH) after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Baseline, 12 wk |
| LDL Receptor (LDLR) | Monocyte LDL receptor mRNA normalized to glyceraldehyde-3-phosphate dehydrogenase after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Change from baseline at 12 weeks |
| LDL Receptor (LDLR) Protein | Monocyte LDL receptor protein by Western blot, normalized to β-actin after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Baseline, 12 weeks |
| Plasma Area Under the Curve of Chokeberry Polyphenols and Their Metabolites. | Plasma area under the curve of chokeberry polyphenols and their metabolites. Measurement (time 0) began at study baseline. Not determined in chronic arms (Color-matched Rice Powder Pill or Chokeberry Extract Capsule). | 0, 0.5, 1, 2, 4, 6, 9, 12, and 24 hours following dose |
| Urinary Excretion of Polyphenols | Urinary excretion of polyphenols, from 0 to 24 h after consumption of extract, area under the curve (AUC) in Chokeberry Extract Capsule (acute) arm only. | 0 to 24 h after consumption of extract |
| Adiponectin | Fasting plasma adiponectin after chronic consumption. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Baseline, 6 weeks, 12 weeks |
| Interleukin-1 Beta | Fasting plasma interleukin-1 beta after chronic consumption. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Baseline, 6 weeks, 12 weeks |
| Interleukin-6 | Fasting plasma interleukin-6 after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Baseline, 6 weeks, 12 weeks |
| Monocyte Chemoattractant Protein-1 | Fasting plasma monocyte chemoattractant protein-1 after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Baseline, 6 weeks, 12 weeks |
| Tumor Necrosis Factor-alpha | Fasting plasma Tumor necrosis factor-alpha after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Baseline, 6 weeks, 12 weeks |
| C-reactive Protein | Fasting plasma C-reactive protein after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Baseline, 6 weeks, 12 weeks |
| Intercellular Adhesion Molecule 1 | Fasting plasma intercellular adhesion molecule 1 after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Baseline, 6 weeks, 12 weeks |
| Soluble Vascular Cell Adhesion Molecule 1 | Fasting plasma soluble vascular cell adhesion molecule 1 after chronic consumption. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Baseline, 6 weeks, 12 weeks |
| P-selectin | Fasting plasma P-selectin after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Baseline, 6 weeks, 12 weeks |
| Total Antioxidant Capacity | Fasting plasma total antioxidant capacity after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Baseline, 6 weeks, 12 weeks |
| Catalase Activity | Catalase activity after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Baseline, 6 weeks, 12 weeks |
| Glutathione Peroxidase Activity | Fasting plasma glutathione peroxidase activity after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Baseline, 6 weeks, 12 weeks |
| Superoxide Dismutase Activity | Fasting plasma superoxide dismutase after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Baseline, 6 weeks, 12 weeks |
| Urinary Polyphenol Excretion | Overnight urinary polyphenol excretion after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | 12 weeks |
| Energy-adjusted Nutrient Intake: Carbohydrate, Protein, Fat, Fiber | Energy-adjusted intake based on 3-day dietary recalls, determined by the average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Baseline, 12 weeks |
| Energy Intake | Energy intake reported from 3-day dietary recalls at baseline and 12 weeks, determined by the average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Baseline, 12 weeks |
| Energy-adjusted Micronutrient Intake | Energy-adjusted micronutrient intake from 3-day dietary recalls at baseline and 12 weeks. Values reported as the average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Baseline, 12 weeks |
| Polyphenol Intake | Energy-adjusted polyphenol intake assessed by 3-day dietary recalls at baseline and 12 weeks, values determined by average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Baseline, 12 weeks |
| Intake of Dietary Antioxidant Capacity | Energy-adjusted intake of dietary antioxidant capacity determined by 3-day dietary recalls at baseline and 12 weeks. Values reported as average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Baseline, 12 weeks |
| Energy-adjusted Vitamin A Intake | Energy-adjusted vitamin A intake from 3-day dietary recalls at baseline and 12 weeks. Values reported as the average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Baseline, 12 weeks |
Chokeberry extract capsule
Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
| BG002 | Chokeberry Extract Capsule (Acute) | Chokeberry extract capsule, acute: Chokeberry extract capsule, 2 x 250 mg, one-time dose. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | m |
|
| Average years of smoking | Missing value for one participant in acute study. | Mean | Standard Deviation | years |
|
| Degree of past smoking | Missing value for one participant in acute study. | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Waist circumference | Mean | Standard Deviation | cm |
|
| Systolic blood pressure | Mean | Standard Deviation | mmHg |
|
| Diastolic blood pressure | Mean | Standard Deviation | mmHg |
|
| Total cholesterol | Mean | Standard Deviation | mg/dL |
|
| HDL-cholesterol | Mean | Standard Deviation | mg/dL |
|
| LDL-cholesterol | Mean | Standard Deviation | mg/dL |
|
| Triglycerides | Mean | Standard Deviation | mg/dL |
|
| Total cholesterol/HDL cholesterol | Mean | Standard Deviation | dimensionless ratio |
|
|
|
| Secondary | Total Cholesterol | Change in fasting total cholesterol from baseline after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Posted | Mean | Standard Error | mg/dL | 6 and 12 weeks after supplementation |
|
|
|
| Secondary | HDL-cholesterol | Change in fasting plasma cholesterol from baseline after chronic supplemenation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Posted | Mean | Standard Error | mg/dL | 6 and 12 weeks after supplementation |
|
|
|
| Secondary | Triglycerides | Change in fasting plasma triglycerides from baseline after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Posted | Mean | Standard Error | mg/dL | 6 and 12 weeks after supplementation |
|
|
|
| Secondary | Resting Systolic Blood Pressure | Change in resting systolic blood pressure after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Posted | Mean | Standard Error | mmHg | Baseline, 6 weeks, and 12 weeks following intervention |
|
|
|
| Secondary | Resting Diastolic Blood Pressure | Change in resting diastolic blood pressure after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Posted | Mean | Standard Error | mmHg | Baseline, 6 weeks, and 12 weeks following intervention |
|
|
|
| Secondary | Urinary F2-isoprostanes | Change in resting urinary F2-isoprostanes after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Posted | Mean | Standard Error | ng/mmol creatinine | Baseline and 12 weeks following intervention |
|
|
|
| Secondary | 3-hydroxy-3-methyl-glutaryl Coenzyme A Reductase (HMGR) | Monocyte messenger ribonucleic acid (mRNA) expression normalized to glyceraldehyde-3-phosphate dehydrogenase (GAPDH) after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Posted | Mean | Standard Error | relative expression (HMGR/GAPDH) | Baseline, 12 wk |
|
|
|
| Secondary | LDL Receptor (LDLR) | Monocyte LDL receptor mRNA normalized to glyceraldehyde-3-phosphate dehydrogenase after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Posted | Mean | Standard Error | relative expression (LDLR/GAPDH) | Change from baseline at 12 weeks |
|
|
|
| Secondary | LDL Receptor (LDLR) Protein | Monocyte LDL receptor protein by Western blot, normalized to β-actin after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Posted | Mean | Standard Error | relative expression (LDLR/β-actin) | Baseline, 12 weeks |
|
|
|
| Secondary | Plasma Area Under the Curve of Chokeberry Polyphenols and Their Metabolites. | Plasma area under the curve of chokeberry polyphenols and their metabolites. Measurement (time 0) began at study baseline. Not determined in chronic arms (Color-matched Rice Powder Pill or Chokeberry Extract Capsule). | Not determined in chronic arms (Color-matched Rice Powder Pill or Chokeberry Extract Capsule) as this analysis required additional collection time-points that were not utilized in the other arms. | Posted | Mean | Standard Error | micrograms x h/mL | 0, 0.5, 1, 2, 4, 6, 9, 12, and 24 hours following dose |
|
|
|
| Secondary | Urinary Excretion of Polyphenols | Urinary excretion of polyphenols, from 0 to 24 h after consumption of extract, area under the curve (AUC) in Chokeberry Extract Capsule (acute) arm only. | Not determined in chronic arms (Color-matched Rice Powder Pill or Chokeberry Extract Capsule) as this analysis required additional collection time-points that were not utilized in the other arms. | Posted | Mean | Standard Error | mg x h/mg creatinine | 0 to 24 h after consumption of extract |
|
|
|
| Secondary | Adiponectin | Fasting plasma adiponectin after chronic consumption. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Posted | Mean | Standard Error | micrograms/mL | Baseline, 6 weeks, 12 weeks |
|
|
|
| Secondary | Interleukin-1 Beta | Fasting plasma interleukin-1 beta after chronic consumption. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Posted | Mean | Standard Error | pg/mL | Baseline, 6 weeks, 12 weeks |
|
|
|
| Secondary | Interleukin-6 | Fasting plasma interleukin-6 after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Posted | Mean | Standard Error | pg/mL | Baseline, 6 weeks, 12 weeks |
|
|
|
| Secondary | Monocyte Chemoattractant Protein-1 | Fasting plasma monocyte chemoattractant protein-1 after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Posted | Mean | Standard Error | pg/mL | Baseline, 6 weeks, 12 weeks |
|
|
|
| Secondary | Tumor Necrosis Factor-alpha | Fasting plasma Tumor necrosis factor-alpha after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Posted | Mean | Standard Error | pg/mL | Baseline, 6 weeks, 12 weeks |
|
|
|
| Secondary | C-reactive Protein | Fasting plasma C-reactive protein after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Posted | Mean | Standard Error | pg/mL | Baseline, 6 weeks, 12 weeks |
|
|
|
| Secondary | Intercellular Adhesion Molecule 1 | Fasting plasma intercellular adhesion molecule 1 after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Posted | Mean | Standard Error | ng/mL | Baseline, 6 weeks, 12 weeks |
|
|
|
| Secondary | Soluble Vascular Cell Adhesion Molecule 1 | Fasting plasma soluble vascular cell adhesion molecule 1 after chronic consumption. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Posted | Mean | Standard Deviation | ng/mL | Baseline, 6 weeks, 12 weeks |
|
|
|
| Secondary | P-selectin | Fasting plasma P-selectin after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Posted | Mean | Standard Error | ng/mL | Baseline, 6 weeks, 12 weeks |
|
|
|
| Secondary | Total Antioxidant Capacity | Fasting plasma total antioxidant capacity after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Posted | Mean | Standard Error | micrograms vitamin C equivalents/mL | Baseline, 6 weeks, 12 weeks |
|
|
|
| Secondary | Catalase Activity | Catalase activity after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Posted | Mean | Standard Error | nmol/min/mL | Baseline, 6 weeks, 12 weeks |
|
|
|
| Secondary | Glutathione Peroxidase Activity | Fasting plasma glutathione peroxidase activity after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Posted | Mean | Standard Error | nmol/min/mL | Baseline, 6 weeks, 12 weeks |
|
|
|
| Secondary | Superoxide Dismutase Activity | Fasting plasma superoxide dismutase after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Posted | Mean | Standard Error | units/mL | Baseline, 6 weeks, 12 weeks |
|
|
|
| Secondary | Urinary Polyphenol Excretion | Overnight urinary polyphenol excretion after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Posted | Median | Inter-Quartile Range | mg/mg creatinine | 12 weeks |
|
|
|
| Secondary | Energy-adjusted Nutrient Intake: Carbohydrate, Protein, Fat, Fiber | Energy-adjusted intake based on 3-day dietary recalls, determined by the average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Survey data were not available for two participants in the "Color-matched rice powder pill" group. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Posted | Mean | Standard Error | g/day | Baseline, 12 weeks |
|
|
|
| Secondary | Energy Intake | Energy intake reported from 3-day dietary recalls at baseline and 12 weeks, determined by the average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Survey data were not available for two participants in the "Color-matched rice powder pill" group. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Posted | Mean | Standard Error | kcal/d | Baseline, 12 weeks |
|
|
|
| Secondary | Energy-adjusted Micronutrient Intake | Energy-adjusted micronutrient intake from 3-day dietary recalls at baseline and 12 weeks. Values reported as the average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Survey data were not available for two participants in the "Color-matched rice powder pill" group. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Posted | Mean | Standard Error | mg/day | Baseline, 12 weeks |
|
|
|
| Secondary | Polyphenol Intake | Energy-adjusted polyphenol intake assessed by 3-day dietary recalls at baseline and 12 weeks, values determined by average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Survey data were not available for two participants in the "Color-matched rice powder pill" group. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Posted | Mean | Standard Error | mg/day | Baseline, 12 weeks |
|
|
|
| Secondary | Intake of Dietary Antioxidant Capacity | Energy-adjusted intake of dietary antioxidant capacity determined by 3-day dietary recalls at baseline and 12 weeks. Values reported as average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Survey data were not available for two participants in the "Color-matched rice powder pill" group. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Posted | Mean | Standard Error | Vitamin C equivalents | Baseline, 12 weeks |
|
|
|
| Secondary | Energy-adjusted Vitamin A Intake | Energy-adjusted vitamin A intake from 3-day dietary recalls at baseline and 12 weeks. Values reported as the average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Survey data were not available for two participants in the "Color-matched rice powder pill" group. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. | Posted | Mean | Standard Error | retinol equivalent mcg/day | Baseline, 12 weeks |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | Chokeberry Extract Capsule | Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks. | 0 | 28 | 0 | 28 | 0 | 28 |
| EG002 | Chokeberry Extract Capsule (Acute) | Chokeberry extract capsule, acute: Chokeberry extract capsule, 2 x 250 mg, one-time dose. | 0 | 6 | 0 | 6 | 0 | 6 |
Not provided
Not provided
| Male |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| 12 weeks (change from baseline) |
|
| 12 weeks (change from baseline) |
|
| 12 weeks (change from baseline) |
|
| 12 weeks (change from baseline) |
|
| 12 weeks (change from baseline) |
|
| Title | Measurements |
|---|---|
|
| Cyanidin-3-O-glucoside |
|
| Peonidin-3-O-galactoside |
|
| Title | Measurements |
|---|---|
|
| 3-(4-hydroxyphenyl)propionic acid |
|
| Cyanidin-3-O-galactoside |
|
| Cyanidin-3-O-glucoside |
|
| Cyanidin-3-O-arabinoside |
|
| Peonidin-3-O-galactoside |
|
| 12 weeks |
|
| 12 weeks |
|
| 12 weeks |
|
| 12 weeks |
|
| 12 weeks |
|
| 12 weeks |
|
| 12 weeks |
|
| 12 weeks |
|
| 12 weeks |
|
| 12 weeks |
|
| 12 weeks |
|
| 12 weeks |
|
| 12 weeks |
|
| Hippuric acid |
|
| Ferulic acid |
|
| 3-(4-hydroxyphenyl)propionic acid |
|
| Cyanidin-3-O-glucoside |
|
| Cyanidin-3-O-galactoside |
|
| Cyanidin-3-O-arabinoside |
|
| Peonidin-3-O-galactoside |
|
| Sum anthocyanins |
|
| Fat |
|
| Fiber |
|
| Iron |
|
| Vitamin D |
|
| Vitamin C |
|
| Vitamin E |
|
| Flavones |
|
| Flavanones |
|
| Flavan-3-ols |
|
| Anthocyanins |
|
| Proanthocyanidins |
|