Clinical trial NCT01295684: Cranberry Juice and Cardiovascular Disease
Official title: The Influence Of Cranberry Juice On Risk Factors For Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Keywords: cranberry
cardiovascular
adhesion
polyphenol
Lead sponsor: USDA Beltsville Human Nutrition Research Center
Sponsor class: FED
Collaborators: name: Ocean Spray, Inc.
First posted: 2011-02-14
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in biomarkers of cardiovascular disease and polyphenol absorption
timeFrame: Days 1&2; Days 27&28; Days 55&56
Secondary outcomes:
measure: Change from baseline in systolic and diastolic blood pressure
timeFrame: Days 1, 28, and 56
measure: Change in urine metabolomics and adhesion analysis
timeFrame: Days 1 & 56
measure: Change in fecal microbiota
timeFrame: Days 1 & 56
Other outcomes:
Locations:
city: Beltsville
country: United States
facility: USDA's Beltsville Human Nutrition Research Center
state: Maryland
Study officials:
affiliation: USDA Beltsville Human Nutrition Research Center
name: Janet Novotny, Ph. D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Novotny JA, Baer DJ, Khoo C, Gebauer SK, Charron CS. Cranberry juice consumption lowers markers of cardiometabolic risk, including blood pressure and circulating C-reactive protein, triglyceride, and glucose concentrations in adults. J Nutr. 2015 Jun;145(6):1185-93. doi: 10.3945/jn.114.203190. Epub 2015 Apr 22.