Tea-beetroot-venous Occlusion Plethysmography

Study Overview
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Brief Summary
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In the present study, muscle perfusion will be studied before and after an oral glucose challenge following a fasting period.

Detailed Description
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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.

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

Conditions
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Insulin Resistance, Obesity

Intervention / Treatment
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* Other: Tea
* Other: Beet root
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tea<br>Oral intake of tea containing 75 grams of glucose | Other: Tea<br>* Oral intake of tea containing 75 grams of glucose<br>|
| Experimental: Beet root<br>Oral intake of beetroot juice containing 75 grams of glucose | Other: Beet root<br>* Oral intake of beetroot juice containing 75 grams of glucose<br>|
| Placebo Comparator: Placebo<br>Oral intake of 75 grams of glucose in water | Other: Placebo<br>* Oral intake of 75 grams of glucose in water<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vascular resistance | Vascular resistance (arm and leg) as obtained from venous occlusion plethysmography and corrected for blood pressure | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| echo-Doppler | Postprandial muscle blood flow (arm and leg) measured by echo-Doppler at the brachial artery and the superficial femoral artery | 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 | 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 | 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. | Approximately 20 minutes before (baseline) and 30, 60, 90, 120, 150 and 180 minutes after test product intake | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, insulin resistance, muscle perfusion