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Tea-beetroot-venous Occlusion Plethysmography

Exploratory Study on the Effect of Nutritional Intervention on Postprandial Skeletal Muscle Microcirculation in Obese Subjects

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01746329
Enrollment
18
Registered
2012-12-10
Start date
2012-12-31
Completion date
2013-05-31
Last updated
2013-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Resistance, Obesity

Keywords

Obesity, insulin resistance, muscle perfusion

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.

Interventions

OTHERTea

Oral intake of tea containing 75 grams of glucose

Oral intake of beetroot juice containing 75 grams of glucose

OTHERPlacebo

Oral intake of 75 grams of glucose in water

Sponsors

Radboud University Medical Center
CollaboratorOTHER
Unilever R&D
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
30 Years to 70 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Vascular resistanceAverage 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

Secondary

MeasureTime frameDescription
echo-DopplerApproximately 20 minutes before (baseline) and 30, 60, 90, 120, 150 and 180 minutes after test product intakePostprandial muscle blood flow (arm and leg) measured by echo-Doppler at the brachial artery and the superficial femoral artery
Near-infrared spectroscopyApproximately 20 minutes before (baseline) and 30, 60, 90, 120, 150 and 180 minutes after test product intakePostprandial muscle blood flow (arm) measured by near-infrared spectroscopy on the extensor carpi radialis brevis muscles of the forearm
Glucose and insulinApproximately 20 minutes before (baseline) and 30, 60, 90, 120, 150 and 180 minutes after test product intakeGlucose and insulin in venous blood plasma
Vascular resistance exploratoryApproximately 20 minutes before (baseline) and 30, 60, 90, 120, 150 and 180 minutes after test product intakeVascular resistance (arm and leg) as obtained from venous occlusion plethysmography and corrected for blood pressure as an exploratory parameter.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026