Tea-beetroot-venous Occlusion Plethysmography

Not Applicable

Completed

• Conditions: Insulin Resistance; Obesity

• Registration Number: NCT01746329
• Lead Sponsor: Unilever R&D

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.

Study Timeline

• Study First Submitted: 2012-11-30
• Study Start: 2012-12
• Study First Submitted QC: 2012-12-07
• Study First Posted: 2012-12-10
• Primary Completion: 2013-04
• Study Completion: 2013-05
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-02
• Last Update Posted: 2013-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Vascular resistance	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Radboud University Nijmegen Medical Centre; 🇳🇱 Nijmegen, Gelderland, Netherlands