Vascular DiseasesNCT02158481
Effects of Dietary Ingredients on Vascular Function
A study testing A capsule containing both polyphenols and carotenoids in people with Vascular Diseases and Impaired Glucose Tolerance, run by Unilever R&D at 1 site in United Kingdom.
Trial summary
The main aim of the study is to investigate the effects of dietary ingredients (polyphenols and carotenoids) on vascular function during acute glucose load. Each subject will receive 4 weeks of intervention with test product or placebo product after a dietary restriction run-in period of 14 days. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Vascular Diseases, Impaired Glucose Tolerance
- What is being tested?
- A capsule containing both polyphenols and carotenoids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2014to Dec 2014
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females confirmed with IGT;
- Age ≥ 35 and ≤ 65 year at screening;
- Body Mass Index (BMI) > 25 and <40 kg/m2;
- Reported intense sporting activities ≤ 10h/w;
- Reported alcohol consumption ≤ 14 units/week (female volunteers) or ≤ 21 units/week (male volunteers)
- Currently not smoking and being a non-smoker for at least six months
Who cannot join
- Any medical condition or use of over-the-counter and prescribed medication which might affect study measurement (judged by the study physician);
- No reported participation in another nutritional or biomedical trial 3 months before screening;
- Reported weight loss or gain of 10% or more during a period of 6 months prior to screening;
- Anti-hyperglycemic drug or other medication which interferes with study measurements;
- No blood donation 1 month prior to screening;
- Reported allergy or intolerance to test products or other food products provided during the study;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Effects of Dietary Ingredients on Vascular Function During Acute Glucose Load
The main aim of the study is to investigate the effects of dietary ingredients (polyphenols and carotenoids) on vascular function during acute glucose load. Each subject will receive 4 weeks of intervention with test product or placebo product after a dietary restriction run-in period of 14 days. Subjects will be challenged with an oral glucose tolerance test (OGTT) immediately after the run-in phase and at the end of the intervention phase. During the OGTT, blood samples will be taken at regular intervals.
The study will be conducted in subjects with impaired glucose tolerance.
- Conditions
- Vascular Diseases, Impaired Glucose Tolerance
- Being tested
- A capsule containing both polyphenols and carotenoids, Placebo intervention
- Keywords
- Vascular function, Dietary ingredients, Acute glucose load, Oxidative stress
- Medical subject headings
- Vascular Diseases, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A capsule containing both polyphenols and carotenoidsDietary supplement
Placebo interventionDietary supplement
Placebo intervention
| Study group | Role | What they receive |
|---|---|---|
| Dietary ingredients: polyphenols and carotenoids | Active comparator | Dietary ingredients: polyphenols and carotenoids Receives: Dietary Supplement: A capsule containing both polyphenols and carotenoids |
| Placebo product | Placebo comparator | Placebo product Receives: Dietary Supplement: Placebo intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukin-6 (IL-6) levels.
Measured: At baseline (after 2 weeks run-in period) and after 4 weeks intervention
Secondary outcomes (3)
Pro-inflammatory and oxidative stress biomarkers
- Luminex HS cytokine, CVD, ADK and MMP panel
- Endothelial derived factors
- Systemic inflammatory cytokines: hsTNFα
- Systemic inflammatory cytokines: hsCRP
- Endothelial cell function markers
- Oxidative stress parameters
Measured: At baseline (after 2 weeks run-in period) and after 4 weeks intervention
Cell stress-defence responses
- Direct \& indirect markers of cell defence activation
- Inflammatory and oxidative stress markers
- Established and exploratory cardiovascular health markers
Measured: At baseline (after 2 weeks run-in period) and after 4 weeks intervention
Clinical chemistry parameters
- Glucose \& Insulin
- Total cholesterol, LDL, HDL, triglycerides, uric acid, Glycated Serum Proteins \& HbA1C.
Measured: At baseline (after run-in period of 2 weeks) and after 4 weeks intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DiseasesStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unilever R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aspect Clinical
- Responsible party
- Sponsor
- Investigators
- Alex Thompson, Dr, Principal investigator, Aspect Clinical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02158481
- Sponsor's protocol ID
- FDS-BNH-0751
- Status last verified
- Jun 2015
- First submitted
- 24 Mar 2014
- Last updated
- 24 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Dietary Ingredients on Vascular Function During Acute Glucose Load
- ClinicalTrials.gov ID
- NCT02158481
- Acronym / sponsor ID
- FDS-BNH-0751
- Conditions
- Vascular Diseases, Impaired Glucose Tolerance
- Keywords
- Vascular function, Dietary ingredients, Acute glucose load, Oxidative stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Collaborators
- Aspect Clinical
- Study start
- Apr 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 6 Jun 2014 (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 main aim of the study is to investigate the effects of dietary ingredients (polyphenols and carotenoids) on vascular function during acute glucose load. Each subject will receive 4 weeks of intervention with test product or placebo product after a dietary restriction run-in period of 14 days. Subjects will be challenged with an oral glucose tolerance test (OGTT) immediately after the run-in phase and at the end of the intervention phase. During the OGTT, blood samples will be taken at regular intervals.
The study will be conducted in subjects with impaired glucose tolerance.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary ingredients: polyphenols and carotenoids | Active comparator | Dietary Supplement: A capsule containing both polyphenols and carotenoidsDietary ingredients: polyphenols and carotenoids |
| Placebo product | Placebo comparator | Dietary Supplement: Placebo interventionPlacebo product |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males or females confirmed with IGT;
- Age ≥ 35 and ≤ 65 year at screening;
- Body Mass Index (BMI) > 25 and <40 kg/m2;
- Reported intense sporting activities ≤ 10h/w;
- Reported alcohol consumption ≤ 14 units/week (female volunteers) or ≤ 21 units/week (male volunteers)
Key exclusion criteria (6 listed)
- Any medical condition or use of over-the-counter and prescribed medication which might affect study measurement (judged by the study physician);
- No reported participation in another nutritional or biomedical trial 3 months before screening;
- Reported weight loss or gain of 10% or more during a period of 6 months prior to screening;
- Anti-hyperglycemic drug or other medication which interferes with study measurements;
- No blood donation 1 month prior to screening;
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 |
|---|---|---|
| A capsule containing both polyphenols and carotenoids | Dietary supplement | Dietary ingredients: polyphenols and carotenoids |
| Placebo interventionPlacebo intervention | Dietary supplement | Placebo product |
Primary outcome
Interleukin-6 (IL-6) levels.
Time frame: At baseline (after 2 weeks run-in period) and after 4 weeks intervention
3 secondary outcomes
Pro-inflammatory and oxidative stress biomarkers
Time frame: At baseline (after 2 weeks run-in period) and after 4 weeks intervention
Cell stress-defence responses
Time frame: At baseline (after 2 weeks run-in period) and after 4 weeks intervention
Clinical chemistry parameters
Time frame: At baseline (after run-in period of 2 weeks) and after 4 weeks intervention
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 24 Jun 2015.
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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.
Alex Thompson, Dr principal investigator
Aspect Clinical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A capsule containing both polyphenols and carotenoids in people with Vascular Diseases and Impaired Glucose Tolerance, run by Unilever R&D 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 6 inclusion and 6 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 24 Jun 2015. 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?
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?
Interleukin-6 (IL-6) levels. (time frame: At baseline (after 2 weeks run-in period) and after 4 weeks intervention). 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 24 Jun 2015.