N/A
Completed N=62
Study of Chokeberry to Reduce Cardiovascular Disease Risk in Former Smokers
Source: ClinicalTrials.gov NCT01541826 ↗Enrolled (actual)
62
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcomePrimary: LDL Cholesterol — 0.9; -12.6; -0.4; -18.5 mg/dL
Summary
The purpose of this project is to determine whether chokeberry polyphenols mitigate cardiovascular disease risk in former smokers.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY LDL Cholesterol |
0.9; -12.6; -0.4; -18.5 | — |
| SECONDARY Total Cholesterol |
203; 220; -0.1; 1.4; -1.3; -17.9 | — |
| SECONDARY HDL-cholesterol |
28.8; 26.8; -0.9; 0.2; -0.7; 0.2 | — |
| SECONDARY Triglycerides |
82.1; 89.6; -0.6; 1.0; -1.0; 2.0 | — |
| SECONDARY Resting Systolic Blood Pressure |
121; 117; -0.8; 2.8; 0.2; 1.2 | — |
| SECONDARY Resting Diastolic Blood Pressure |
76.0; 75.3; -1.2; 5.0; -1.1; 2.0 | — |
| SECONDARY Urinary F2-isoprostanes |
71.0; 58.6; 81.6; 68.4 | — |
| SECONDARY 3-hydroxy-3-methyl-glutaryl Coenzyme A Reductase (HMGR) |
0.90; 0.91; 1.16; 0.79 | — |
| SECONDARY LDL Receptor (LDLR) |
0.90; 0.84; 0.93; 0.88 | — |
| SECONDARY LDL Receptor (LDLR) Protein |
1.71; 1.45; 2.47; 1.45 | — |
| SECONDARY Plasma Area Under the Curve of Chokeberry Polyphenols and Their Metabolites. |
0.054; 22.350; 2.725; 0.462; 0.627 | — |
| SECONDARY Urinary Excretion of Polyphenols |
3.682; 11.426; 2429.852; 2.299; 0.016; 0.118 | — |
| SECONDARY Adiponectin |
13.2; 12.8; 14.2; 13.8; 12.5; 13.2 | — |
| SECONDARY Interleukin-1 Beta |
9.3; 16.2; 9.5; 17.0; 10.1; 14.7 | — |
| SECONDARY Interleukin-6 |
1.94; 4.68; 1.87; 5.16; 1.76; 5.34 | — |
| SECONDARY Monocyte Chemoattractant Protein-1 |
97; 133; 96; 167; 91; 141 | — |
| SECONDARY Tumor Necrosis Factor-alpha |
4.36; 5.90; 4.70; 6.44; 4.86; 6.10 | — |
| SECONDARY C-reactive Protein |
2.54; 2.01; 2.18; 2.32; 2.24; 2.29 | — |
| SECONDARY Intercellular Adhesion Molecule 1 |
97.1; 96.6; 97.6; 99.4; 100; 97.5 | — |
| SECONDARY Soluble Vascular Cell Adhesion Molecule 1 |
585; 601; 604; 622; 604; 599 | — |
| SECONDARY P-selectin |
130; 124; 111; 127; 131; 145 | — |
| SECONDARY Total Antioxidant Capacity |
210; 208; 214; 211; 209; 207 | — |
| SECONDARY Catalase Activity |
41.7; 41.1; 35.5; 38.7; 41.7; 41.2 | — |
| SECONDARY Glutathione Peroxidase Activity |
2550; 2550; 2560; 2500; 2470; 2650 | — |
| SECONDARY Superoxide Dismutase Activity |
1190; 1180; 1190; 1160; 1160; 1160 | — |
| SECONDARY Urinary Polyphenol Excretion |
1.38; 1.20; 5.04; 4.56; 133; 138 | — |
| SECONDARY Energy-adjusted Nutrient Intake: Carbohydrate, Protein, Fat, Fiber |
238; 241; 89.2; 90.3; 27.8; 77.6 | — |
| SECONDARY Energy Intake |
2230; 1950 | — |
| SECONDARY Energy-adjusted Micronutrient Intake |
3490; 3480; 947; 1070; 16.9; 16.9 | — |
| SECONDARY Polyphenol Intake |
3.9; 8.5; 73.9; 81.7; 54.1; 50.3 | — |
| SECONDARY Intake of Dietary Antioxidant Capacity |
417; 292 | — |
| SECONDARY Energy-adjusted Vitamin A Intake |
3280; 2690 | — |
Eligibility Criteria
Inclusion Criteria
- Former smoker (previously smoked ≥3 cigarettes/day for at least 1 year, cessation for at least 6 months
- Healthy male or female between 18-65 y
- Serum clinical ranges no more than mildly elevated (serum cholesterol <240 mg/dL) and serum triglyceride (<150 mg/dL)
- Resting blood pressure <140/90 mm Hg
- Stable body weight (±5 lb) for last 2 months
- BMI ranges within normal and overweight (18.5-39 kg/m2)
- Willing to maintain normal exercise level (<7 h/wk)
- Willing to avoid exercise 24 h prior to blood sampling
- Willing to ingest a dietary chokeberry supplement or placebo (500 mg/d) daily for 12 wks.
Exclusion Criteria
- Previous diagnoses of CVD, diabetes, or arthritis (except for osteo-arthritis)
- Currently being treated for cancer (i.e., chemotherapy, radiation therapy)
- Women with prescribed estrogen replacement therapy
- Practicing slimming diet
- Practicing vegetarian diet
- Currently taking vitamin or mineral supplements or plant pills
- Alcohol consumption exceeding the definition of moderate drinking (2 drinks/day or a total of 12/week for men or 1 drink/day or a total of 7/week for women)
Data sourced from ClinicalTrials.gov (NCT01541826). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.