Cardiovascular Disease
Conditions
Keywords
cranberry, cardiovascular, adhesion, polyphenol
Brief summary
Previous studies have shown that consumption of a low calorie cranberry beverage imparts a favorable impact on HDL cholesterol, LDL oxidation, and cell adhesion molecules in men. However, these studies were not well controlled. Thus, it is important to confirm these effects in a blinded, placebo-controlled feeding study. The investigators goal is to verify the cardioprotective effects of cranberries by conducting a dietary intervention trial with healthy subjects in a controlled environment.
Interventions
OTHERCranberry juice
base diet supplemented with two 8 ounce servings of low calorie cranberry juice per day
OTHERPlacebo
base diet supplemented with two 8 ounce servings of a color and flavor matched placebo beverage
Sponsors
Ocean Spray, Inc.
United States Department of Agriculture (USDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 25 to 65 years of age * BMI 20 to 38 kg/m2
Exclusion criteria
* history of bariatric or certain other surgeries related to weight control * kidney disease, liver disease, certain cancers, gout, hyperthyroidism, untreated or unstable hypothyroidism, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes * Type 2 diabetes or use of glucose-lowering medication * Have a fasting blood sugar greater than 126 mg/dL * LDL-cholesterol less than 130 mg/dL * fasting triglycerides greater than 300 mg/dL * use of cholesterol-lowering medication or supplements * use of blood pressure-lowering medication * smoking or use of other tobacco products (within 6 months prior to the start of the study) * unwillingness to abstain from vitamin, mineral, and herbal supplements for 2 weeks prior to the study and during the study * use antibiotics during the study,or for 3 weeks prior to starting the study. * history of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets) * weight loss of \>/= 10% of your body weight within the last 12 months or plan to initiate a weight loss program during the next 10 months * inability to eat cranberries * inability or unwillingness to give informed consent or communicate with study staff * self-reported history of alcohol or substance abuse within the past 12 months and/or are currently in treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion) * other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in biomarkers of cardiovascular disease and polyphenol absorption | Days 1&2; Days 27&28; Days 55&56 | A blood lipid panel will include plasma total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, Apo A-1, Apo A-II, Apo B, Lpa. Inflammatory markers (IL-6, IL-10, IL-1-alpha, CRP, TNF-alpha, fibrinogen, iCAM) will be determined by ELISA. Serum will be analyzed for polyphenol concentration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in systolic and diastolic blood pressure | Days 1, 28, and 56 | Blood pressure will be measured using a standardized protocol at the beginning, 4-week, and 8-week time points. |
| Change in urine metabolomics and adhesion analysis | Days 1 & 56 | Urine (24 hour cumulative and spot)will be collected at the beginning and end of each treatment period and provided to Ocean Spray for metabolomics and adhesion analysis. |
| Change in fecal microbiota | Days 1 & 56 | A spot fecal sample will be collected at the beginning and end of each treatment period and provided to Ocean Spray microbiota analysis. |
Countries
United States
Outcome results
None listed