InflammationNCT01527617
Effect of Chronic Consumption of a Cranberry Beverage on Inflammation and Oxidative Stress
A study testing Cranberry and Non-Cranberry beverage in people with Inflammation, run by Tufts University at 2 sites in United States.
Trial summary
The objective of this randomized, double-blind, placebo-controlled, parallel-design clinical trial is to investigate the potential antioxidant benefits of a cranberry beverage. The investigators hypothesize the chronic consumption of this beverage will improve indices of oxidative stress, inflammation, endothelial… Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation
- What is being tested?
- Cranberry and Non-Cranberry beverage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2012to Feb 2013
- 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men \& women, aged 30-70 years
- BMI 27-34.9 kg/m2
- waist:hip ratio > 0.8 for women and > 0.9 for men
Who cannot join
- Cigarette smoking and/or nicotine replacement use within last 6 months
- Individuals taking estrogen or testosterone
- Use of cholesterol-lowering medications
- Use of blood pressure-lowering medications
- Regular use (> 1x/wk) of any stomach acid-lowering medications or laxatives (including fiber supplements)
- Cardiovascular (heart) disease
Show all 20Show fewer
- Gastrointestinal disease
- Kidney disease
- Endocrine disease: including diabetes, untreated thyroid disease
- Rheumatoid arthritis
- Immune deficiency conditions
- Active treatment for any type of cancer, except basal cell carcinoma, within 1 year prior to study admission
- Systolic blood pressure > 139 mmHg and/or diastolic blood pressure > 89 mmHg
- Regular use of systemic steroids, oral or injectable
- Regular daily intake of ≥ 2 alcoholic drinks
- Infrequent (< 3/week) or excessive (> 3/d) number of regular bowel movements
- Gain or loss of ≥ 5% of body weight in the last 6 months
- Pregnancy
- Strict vegetarians
- No dietary supplements, including those containing any vitamins, minerals, herbs, plant concentrates (including garlic, gingko, St. John's wort) homeopathic remedies, probiotics, or fish oil (including cod liver oil), for one month prior to study admission
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, 02111
Washington State University
Pullman, Washington, 99164
About this study
Official title: The Effect of Chronic Consumption of a Cranberry Beverage on Inflammation and Oxidative Stress in Healthy But Overweight/Obese Subjects: A Randomized Clinical Trial
The objective of this randomized, double-blind, placebo-controlled, parallel-design clinical trial is to investigate the potential antioxidant benefits of a cranberry beverage. The investigators hypothesize the chronic consumption of this beverage will improve indices of oxidative stress, inflammation, endothelial function, and glucoregulation. The investigators also hypothesize that these benefits will be particularly evident following an oral glucose tolerance test.
- Conditions
- Inflammation
- Being tested
- Cranberry, Non-Cranberry beverage
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CranberryOther
beverage containing cranberry at a dose of 15.2 ounces per day for 56 days.
Non-Cranberry beverageOther
Placebo Comparator - beverage absent cranberry at a dose of 15.2 ounces per day for 56 days.
| Study group | Role | What they receive |
|---|---|---|
| Cranberry beverage | Active comparator | Not described Receives: Other: Cranberry |
| Non-cranberry beverage | Placebo comparator | Not described Receives: Other: Non-Cranberry beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in biomarkers of inflammation compared with placebo
Measured: Baseline and 8 weeks
Change in biomarkers of oxidative stress compared with placebo.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionJan 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- Washington State University, Ocean Spray, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01527617
- Sponsor's protocol ID
- IRB10178
- Status last verified
- Jun 2016
- First submitted
- 30 Jan 2012
- Last updated
- 2 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Chronic Consumption of a Cranberry Beverage on Inflammation and Oxidative Stress in Healthy But Overweight/Obese Subjects: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01527617
- Acronym / sponsor ID
- IRB10178
- Conditions
- Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- Washington State University, Ocean Spray, Inc.
- Study start
- Feb 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 7 Feb 2012 (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.
The objective of this randomized, double-blind, placebo-controlled, parallel-design clinical trial is to investigate the potential antioxidant benefits of a cranberry beverage. The investigators hypothesize the chronic consumption of this beverage will improve indices of oxidative stress, inflammation, endothelial function, and glucoregulation. The investigators also hypothesize that these benefits will be particularly evident following an oral glucose tolerance test.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cranberry beverage | Active comparator | Other: Cranberry |
| Non-cranberry beverage | Placebo comparator | Other: Non-Cranberry beverage |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men \& women, aged 30-70 years
- BMI 27-34.9 kg/m2
- waist:hip ratio > 0.8 for women and > 0.9 for men
Key exclusion criteria (20 listed)
- Cigarette smoking and/or nicotine replacement use within last 6 months
- Individuals taking estrogen or testosterone
- Use of cholesterol-lowering medications
- Use of blood pressure-lowering medications
- Regular use (> 1x/wk) of any stomach acid-lowering medications or laxatives (including fiber supplements)
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 |
|---|---|---|
| Cranberrybeverage containing cranberry at a dose of 15.2 ounces per day for 56 days. | Other | Cranberry beverage |
| Non-Cranberry beveragePlacebo Comparator - beverage absent cranberry at a dose of 15.2 ounces per day for 56 days. | Other | Non-cranberry beverage |
Primary outcome
Change in biomarkers of inflammation compared with placebo
Time frame: Baseline and 8 weeks
Change in biomarkers of oxidative stress compared with placebo.
Time frame: Baseline and 8 weeks
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 2 Jun 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cranberry and Non-Cranberry beverage in people with Inflammation, run by Tufts University at 2 sites 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 3 inclusion and 20 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 2 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 inflammation compared with placebo (time frame: Baseline and 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jun 2016.