Insulin ResistanceNCT01746329
Tea-beetroot-venous Occlusion Plethysmography
A study testing Tea and Beet root in people with Insulin Resistance and Obesity, run by Unilever R&D at 1 site in Netherlands.
Trial summary
In the present study, muscle perfusion will be studied before and after an oral glucose challenge following a fasting period. Read more about this study
- Who is it for?
- Ages 30 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Obesity
- What is being tested?
- Tea and Beet root
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2012to May 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male sex
- Aged 30-70 years.
- Obesity (BMI>30 kg/m2)
- insulin resistance as fasting glucose levels >6.1 mmol/L.
- Reported intense sport activities >10 h/w.
- Reported alcohol consumption >28 units/w
- Signed Informed consent
- Currently not smoking and being a non-smoker for at least 3 months prior to the start of the study.
Who cannot join
- BMI ≥ 40 kg/m2.
- Presence of cardiovascular disease.
- Presence of sudden cardiac death in a 1st degree relative at an age <50 years.
- Presence of diabetes mellitus type 2.
- Regular tea drinker (> 2 cups per day)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, 6500 HB
About this study
Official title: Exploratory Study on the Effect of Nutritional Intervention on Postprandial Skeletal Muscle Microcirculation in Obese Subjects
In the present study, muscle perfusion will be studied before and after an oral glucose challenge following a fasting period.
Read the detailed description
Based on data from previous studies, this physiological response is blunted in obese subjects, and the investigators expect these responses to be restored when the glucose load is combined with tea or beetroot juice in obese, insulin resistant men.
- Conditions
- Insulin Resistance, Obesity
- Being tested
- Tea, Beet root, Placebo
- Keywords
- Obesity, insulin resistance, muscle perfusion
- Medical subject headings
- Insulin Resistance, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeaOther
Oral intake of tea containing 75 grams of glucose
Beet rootOther
Oral intake of beetroot juice containing 75 grams of glucose
PlaceboOther
Oral intake of 75 grams of glucose in water
| Study group | Role | What they receive |
|---|---|---|
| Tea | Experimental | Oral intake of tea containing 75 grams of glucose Receives: Other: Tea |
| Beet root | Experimental | Oral intake of beetroot juice containing 75 grams of glucose Receives: Other: Beet root |
| Placebo | Placebo comparator | Oral intake of 75 grams of glucose in water Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular resistance
Vascular resistance (arm and leg) as obtained from venous occlusion plethysmography and corrected for blood pressure
Measured: Average of values obtained at 30, 60, 90, 120, 150 and 180 minutes after test product intake corrected for the value obtained at approximately 20 minutes before test product intake (baseline)
Secondary outcomes (4)
echo-Doppler
Postprandial muscle blood flow (arm and leg) measured by echo-Doppler at the brachial artery and the superficial femoral artery
Measured: Approximately 20 minutes before (baseline) and 30, 60, 90, 120, 150 and 180 minutes after test product intake
Near-infrared spectroscopy
Postprandial muscle blood flow (arm) measured by near-infrared spectroscopy on the extensor carpi radialis brevis muscles of the forearm
Measured: Approximately 20 minutes before (baseline) and 30, 60, 90, 120, 150 and 180 minutes after test product intake
Glucose and insulin
Glucose and insulin in venous blood plasma
Measured: Approximately 20 minutes before (baseline) and 30, 60, 90, 120, 150 and 180 minutes after test product intake
Vascular resistance exploratory
Vascular resistance (arm and leg) as obtained from venous occlusion plethysmography and corrected for blood pressure as an exploratory parameter.
Measured: Approximately 20 minutes before (baseline) and 30, 60, 90, 120, 150 and 180 minutes after test product intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionApr 2013
- Study completionMay 2013
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 Insulin ResistanceStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unilever R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Radboud University Medical Center
- Responsible party
- Sponsor
- Investigators
- M Hopman, Prof DR, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01746329
- Sponsor's protocol ID
- FDS-BNH-0809
- Other IDs
- Arnhem-Nijmegen 2012/357
- Status last verified
- Aug 2013
- First submitted
- 30 Nov 2012
- Last updated
- 5 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Fuchs D, Nyakayiru J, Draijer R, Mulder TP, Hopman MT, Eijsvogels TM, Thijssen DH. Impact of flavonoid-rich black tea and beetroot juice on postprandial peripheral vascular resistance and glucose homeostasis in obese, insulin-resistant men: a randomized controlled trial. Nutr Metab (Lond). 2016 May 13;13:34. doi: 10.1186/s12986-016-0094-x. eCollection 2016.
PubMed 27182277
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study on the Effect of Nutritional Intervention on Postprandial Skeletal Muscle Microcirculation in Obese Subjects
- ClinicalTrials.gov ID
- NCT01746329
- Acronym / sponsor ID
- FDS-BNH-0809
- Conditions
- Insulin Resistance, Obesity
- Keywords
- Obesity, insulin resistance, muscle perfusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Collaborators
- Radboud University Medical Center
- Study start
- Dec 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 10 Dec 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.
In the present study, muscle perfusion will be studied before and after an oral glucose challenge following a fasting period.
Detailed description
Based on data from previous studies, this physiological response is blunted in obese subjects, and the investigators expect these responses to be restored when the glucose load is combined with tea or beetroot juice in obese, insulin resistant men.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tea | Experimental | Other: TeaOral intake of tea containing 75 grams of glucose |
| Beet root | Experimental | Other: Beet rootOral intake of beetroot juice containing 75 grams of glucose |
| Placebo | Placebo comparator | Other: PlaceboOral intake of 75 grams of glucose in water |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male sex
- Aged 30-70 years.
- Obesity (BMI>30 kg/m2)
- insulin resistance as fasting glucose levels >6.1 mmol/L.
- Reported intense sport activities >10 h/w.
Key exclusion criteria (5 listed)
- BMI ≥ 40 kg/m2.
- Presence of cardiovascular disease.
- Presence of sudden cardiac death in a 1st degree relative at an age <50 years.
- Presence of diabetes mellitus type 2.
- Regular tea drinker (> 2 cups per day)
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 |
|---|---|---|
| TeaOral intake of tea containing 75 grams of glucose | Other | Tea |
| Beet rootOral intake of beetroot juice containing 75 grams of glucose | Other | Beet root |
| PlaceboOral intake of 75 grams of glucose in water | Other | Placebo |
Primary outcome
Vascular resistance
Time frame: Average of values obtained at 30, 60, 90, 120, 150 and 180 minutes after test product intake corrected for the value obtained at approximately 20 minutes before test product intake (baseline)
Vascular resistance (arm and leg) as obtained from venous occlusion plethysmography and corrected for blood pressure
4 secondary outcomes
echo-Doppler
Time frame: Approximately 20 minutes before (baseline) and 30, 60, 90, 120, 150 and 180 minutes after test product intake
Near-infrared spectroscopy
Time frame: Approximately 20 minutes before (baseline) and 30, 60, 90, 120, 150 and 180 minutes after test product intake
Glucose and insulin
Time frame: Approximately 20 minutes before (baseline) and 30, 60, 90, 120, 150 and 180 minutes after test product intake
Vascular resistance exploratory
Time frame: Approximately 20 minutes before (baseline) and 30, 60, 90, 120, 150 and 180 minutes after test product intake
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 5 Aug 2013.
- Derived from this study: PubMed 27182277Fuchs D, Nyakayiru J, Draijer R, Mulder TP, Hopman MT, Eijsvogels TM, Thijssen DH. Impact of flavonoid-rich black tea and beetroot juice on postprandial peripheral vascular resistance and glucose homeostasis in obese, insulin-resistant men: a randomized controlled trial. Nutr Metab (Lond). 2016 May 13;13:34. doi: 10.1186/s12986-016-0094-x. eCollection 2016.
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Healthy Volunteer
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.
M Hopman, Prof DR principal investigator
Radboud University Medical 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 Tea and Beet root in people with Insulin Resistance and Obesity, run by Unilever R&D at 1 site in Netherlands.
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 8 inclusion and 5 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 5 Aug 2013. 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 Netherlands. 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?
Vascular resistance (time frame: Average of values obtained at 30, 60, 90, 120, 150 and 180 minutes after test product intake corrected for the value obtained at approximately 20 minutes before test product intake (baseline)). 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 NCT01746329, 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 5 Aug 2013.