Tea-beetroot-venous Occlusion Plethysmography

Unilever R&D18 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Insulin Resistance Obesity

Interventions

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

Eligibility

Sex: MALEMin age: 30 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, Netherlands

Outcomes

Primary Outcomes

Vascular resistance

Vascular resistance (arm and leg) as obtained from venous occlusion plethysmography and corrected for blood pressure

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)

Secondary Outcomes

echo-Doppler

Postprandial muscle blood flow (arm and leg) measured by echo-Doppler at the brachial artery and the superficial femoral artery

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: Approximately 20 minutes before (baseline) and 30, 60, 90, 120, 150 and 180 minutes after test product intake

Data from ClinicalTrials.gov

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