Cardiovascular DiseaseNCT01295684
Cranberry Juice and Cardiovascular Disease
A study testing Cranberry juice in people with Cardiovascular Disease, run by United States Department of Agriculture (USDA) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Cranberry juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 25 to 65 years of age
- BMI 20 to 38 kg/m2
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA's Beltsville Human Nutrition Research Center
Beltsville, Maryland, 20705
About this study
Official title: The Influence Of Cranberry Juice On Risk Factors For Cardiovascular Disease
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.
- Conditions
- Cardiovascular Disease
- Being tested
- Cranberry juice, Placebo
- Keywords
- cranberry, cardiovascular, adhesion, polyphenol
- Medical subject headings
- Cardiovascular Diseases, Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cranberry juiceOther
base diet supplemented with two 8 ounce servings of low calorie cranberry juice per day
PlaceboOther
base diet supplemented with two 8 ounce servings of a color and flavor matched placebo beverage
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Base diet supplemented with two 8 ounce servings of a color and flavor matched placebo beverage. Receives: Other: Placebo |
| Cranberry Juice | Experimental | Base diet supplemented with two 8 ounce servings of low calorie cranberry juice per day. Receives: Other: Cranberry juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in biomarkers of cardiovascular disease and polyphenol absorption
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.
Measured: Days 1&2; Days 27&28; Days 55&56
Secondary outcomes (3)
Change from baseline in systolic and diastolic blood pressure
Blood pressure will be measured using a standardized protocol at the beginning, 4-week, and 8-week time points.
Measured: Days 1, 28, and 56
Change in urine metabolomics and adhesion analysis
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.
Measured: Days 1 & 56
Change in fecal microbiota
A spot fecal sample will be collected at the beginning and end of each treatment period and provided to Ocean Spray microbiota analysis.
Measured: Days 1 & 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2011 (estimated)
- Study startSep 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United States Department of Agriculture (USDA)
- Sponsor type
- US federal agency
- Collaborators
- Ocean Spray, Inc.
- Investigators
- Janet Novotny, Ph. D., Principal investigator, USDA Beltsville Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01295684
- Sponsor's protocol ID
- 2010-085
- Status last verified
- Feb 2011
- First submitted
- 11 May 2010
- Last updated
- 14 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25904733
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence Of Cranberry Juice On Risk Factors For Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT01295684
- Acronym / sponsor ID
- 2010-085
- Conditions
- Cardiovascular Disease
- Keywords
- cranberry, cardiovascular, adhesion, polyphenol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- United States Department of Agriculture (USDA)US federal agency
- Collaborators
- Ocean Spray, Inc.
- Study start
- Sep 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 14 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Other: PlaceboBase diet supplemented with two 8 ounce servings of a color and flavor matched placebo beverage. |
| Cranberry Juice | Experimental | Other: Cranberry juiceBase diet supplemented with two 8 ounce servings of low calorie cranberry juice per day. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 25 to 65 years of age
- BMI 20 to 38 kg/m2
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cranberry juicebase diet supplemented with two 8 ounce servings of low calorie cranberry juice per day | Other | Cranberry Juice |
| Placebobase diet supplemented with two 8 ounce servings of a color and flavor matched placebo beverage | Other | placebo |
Primary outcome
Change in biomarkers of cardiovascular disease and polyphenol absorption
Time frame: 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.
3 secondary outcomes
Change from baseline in systolic and diastolic blood pressure
Time frame: Days 1, 28, and 56
Change in urine metabolomics and adhesion analysis
Time frame: Days 1 & 56
Change in fecal microbiota
Time frame: Days 1 & 56
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2011.
- Derived from this study: PubMed 25904733Novotny 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janet Novotny, Ph. D. principal investigator
USDA Beltsville Human Nutrition Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cranberry juice in people with Cardiovascular Disease, run by United States Department of Agriculture (USDA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in biomarkers of cardiovascular disease and polyphenol absorption (time frame: Days 1&2; Days 27&28; Days 55&56). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01295684, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2011.