Clinical trial NCT01746329: Tea-beetroot-venous Occlusion Plethysmography
Official title: Exploratory Study on the Effect of Nutritional Intervention on Postprandial Skeletal Muscle Microcirculation in Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Obesity
Keywords: Obesity, insulin resistance, muscle perfusion
Lead sponsor: Unilever R&D
Sponsor class: INDUSTRY
Collaborators: name: Radboud University Medical Center
First posted: 2012-12-10
Enrollment: 18
Sex: MALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Vascular resistance
timeFrame: 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:
measure: echo-Doppler
timeFrame: Approximately 20 minutes before (baseline) and 30, 60, 90, 120, 150 and 180 minutes after test product intake
measure: Near-infrared spectroscopy
timeFrame: Approximately 20 minutes before (baseline) and 30, 60, 90, 120, 150 and 180 minutes after test product intake
measure: Glucose and insulin
timeFrame: Approximately 20 minutes before (baseline) and 30, 60, 90, 120, 150 and 180 minutes after test product intake
measure: Vascular resistance exploratory
timeFrame: Approximately 20 minutes before (baseline) and 30, 60, 90, 120, 150 and 180 minutes after test product intake
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: M Hopman, Prof DR
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.