Cardiovascular DiseaseNCT00795834
Effects of a Beverage Rich in Fruit Extracts on Risk Factors Associated With Cardiovascular Disease
A study testing High polyphenol beverage in people with Cardiovascular Disease, run by University of Glasgow at 1 site in United Kingdom.
Trial summary
The purpose of this study is to assess the effects of a novel beverage rich in polyphenols (compounds present in fruit extracts) on risk factors associated with cardiovascular disease. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- High polyphenol beverage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2008to Mar 2009
- 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age >/= 55 years
- BMI > 25
Who cannot join
- Present smoker or smoked within the last 2 years
- HBA1C > 6.0%
- eGFR<60
- LFT >/= 3 times upper limit of normal
- Hypertension: systolic blood pressure > 160mmHg; diastolic blood pressure > 90mmHg, or on medication for hypertension.
- Chronic disease, likely to be clinically relevant (eg:
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- cardiorespiratory, rheumatological, cerebrovascular or neoplastic disease)
- Vitamin supplements within the previous 14 days
- Medications which, in the opinion of the investigators, are known to influence vascular function (eg corticosteroids).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
British Heart Foundation Glasgow Cardiovascular Research Centre
Glasgow, G12 8TA
Adam Mullan, MBChB BSc MRCP, +44-141-330-2569
Adam WF Mullan, BSc MBChB MRCP
About this study
Official title: Pilot Study to Assess Effects of Novel Beverages on Established and Novel Risk Markers for Vascular Disease
The purpose of this study is to assess the effects of a novel beverage rich in polyphenols (compounds present in fruit extracts) on risk factors associated with cardiovascular disease.
Read the detailed description
This study will assess the potential of a beverage containing plant and fruit extracts rich in polyphenolics to modulate vascular risk.
Novel risk factors for vascular disease will be assessed including non-invasive assessment of vascular function by pulse wave analysis / pulse wave velocity and laser doppler iontophoresis.
- Conditions
- Cardiovascular Disease
- Being tested
- High polyphenol beverage, Placebo Beverage
- Keywords
- polyphenolics, flavonols, lipids, endothelial function, vascular risk factors
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High polyphenol beverageDietary supplement
Antioxidant capacity umol TE/L(ORAC): 19987 Polyphenolic Content(mcg/ml): 1445 Vitamin C (mg/100ml): 35.35 Calorie Content (Kcal/250ml):40.0
250ml twice daily for 1 month (56 doses)
Placebo BeverageDietary supplement
Antioxidant capacity umol TE/L(ORAC): negligible Polyphenolic Content(mcg/ml): negligible Vitamin C (mg/100ml): 0.00 Calorie Content (Kcal/250ml):40.0
250ml twice daily for 1 month (56 doses)
| Study group | Role | What they receive |
|---|---|---|
| Beverage | Placebo comparator | Not described Receives: Dietary Supplement: Placebo Beverage |
| High Polyphenol Beverage | Active comparator | Not described Receives: Dietary Supplement: High polyphenol beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular Function (measured by Laser Doppler Iontophoresis and Pulse Wave Analysis / Pulse Wave Velocity)
Measured: Baseline and post intervention
Secondary outcomes (1)
Established and novel blood markers for vascular disease
Measured: baseline and post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2008 (estimated)
- Study startJun 2008
- Primary completionJan 2009 (estimated)
- Study completionMar 2009 (estimated)
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Investigators
- Naveed Sattar, MBChB PhD FRCPath FRCP, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00795834
- Sponsor's protocol ID
- 07/S0704/110
- Other IDs
- RN08BI013
- Status last verified
- Nov 2008
- First submitted
- 19 Nov 2008
- Last updated
- 21 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Mullan A, Delles C, Ferrell W, Mullen W, Edwards CA, McColl JH, Roberts SA, Lean ME, Sattar N. Effects of a beverage rich in (poly)phenols on established and novel risk markers for vascular disease in medically uncomplicated overweight or obese subjects: A four week randomized placebo-controlled trial. Atherosclerosis. 2016 Mar;246:169-76. doi: 10.1016/j.atherosclerosis.2016.01.004. Epub 2016 Jan 6.
PubMed 26797134
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Assess Effects of Novel Beverages on Established and Novel Risk Markers for Vascular Disease
- ClinicalTrials.gov ID
- NCT00795834
- Acronym / sponsor ID
- 07/S0704/110
- Conditions
- Cardiovascular Disease
- Keywords
- polyphenolics, flavonols, lipids, endothelial function, vascular risk factors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Jan 2009 (estimated)
- Study completion
- Mar 2009 (estimated)
- First posted
- 21 Nov 2008 (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 purpose of this study is to assess the effects of a novel beverage rich in polyphenols (compounds present in fruit extracts) on risk factors associated with cardiovascular disease.
Detailed description
This study will assess the potential of a beverage containing plant and fruit extracts rich in polyphenolics to modulate vascular risk.
Novel risk factors for vascular disease will be assessed including non-invasive assessment of vascular function by pulse wave analysis / pulse wave velocity and laser doppler iontophoresis.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beverage | Placebo comparator | Dietary Supplement: Placebo Beverage |
| High Polyphenol Beverage | Active comparator | Dietary Supplement: High polyphenol beverage |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age >/= 55 years
- BMI > 25
Key exclusion criteria (9 listed)
- Present smoker or smoked within the last 2 years
- HBA1C > 6.0%
- eGFR<60
- LFT >/= 3 times upper limit of normal
- Hypertension: systolic blood pressure > 160mmHg; diastolic blood pressure > 90mmHg, or on medication for hypertension.
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 |
|---|---|---|
| High polyphenol beverageAntioxidant capacity umol TE/L(ORAC): 19987 Polyphenolic Content(mcg/ml): 1445 Vitamin C (mg/100ml): 35.35 Calorie Content (Kcal/250ml):40.0 250ml twice daily for 1 month (56 doses) | Dietary supplement | High Polyphenol Beverage |
| Placebo BeverageAntioxidant capacity umol TE/L(ORAC): negligible Polyphenolic Content(mcg/ml): negligible Vitamin C (mg/100ml): 0.00 Calorie Content (Kcal/250ml):40.0 250ml twice daily for 1 month (56 doses) | Dietary supplement | Beverage |
Primary outcome
Vascular Function (measured by Laser Doppler Iontophoresis and Pulse Wave Analysis / Pulse Wave Velocity)
Time frame: Baseline and post intervention
1 secondary outcome
Established and novel blood markers for vascular disease
Time frame: baseline and post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2008.
- Derived from this study: PubMed 26797134Mullan A, Delles C, Ferrell W, Mullen W, Edwards CA, McColl JH, Roberts SA, Lean ME, Sattar N. Effects of a beverage rich in (poly)phenols on established and novel risk markers for vascular disease in medically uncomplicated overweight or obese subjects: A four week randomized placebo-controlled trial. Atherosclerosis. 2016 Mar;246:169-76. doi: 10.1016/j.atherosclerosis.2016.01.004. Epub 2016 Jan 6.
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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.
Naveed Sattar, MBChB PhD FRCPath FRCP principal investigator
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High polyphenol beverage in people with Cardiovascular Disease, run by University of Glasgow at 1 site in United Kingdom.
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 9 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: status not confirmed, as of the sponsor's last update on 21 Nov 2008. 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 Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adam WF Mullan, MBChB MRCP (+44-141-330-2569, a.mullan@clinmed.gla.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascular Function (measured by Laser Doppler Iontophoresis and Pulse Wave Analysis / Pulse Wave Velocity) (time frame: Baseline and post intervention). 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 NCT00795834, 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 21 Nov 2008.